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- 197 Jobs
  • Associate Mfg I

    Amgen 4.8company rating

    Amgen Job In West Greenwich, RI Or Remote

    HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Associate Manufacturing I - Days Live What you will do Let's do this! Let's change the world! In this vital role you will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs), these can include bioreactor cleaning, steaming, inoculation, etc., operations. Perform and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Perform basic troubleshooting and assist in the review of documentation for assigned functions. Participate on cross-functional teams and represent the manufacturing teams. May also have the responsibility of owning deviations/CAPAs. Identify, recommend, and implement improvements related to routine functions. This position is for the AR5 A shift Upstream Cell Culture (Perfusion, Production, Harvest - PPH) team. The successful candidate will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7AM-7PM with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay. Qualifications Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an excellent teammate with these qualifications. Basic Qualifications: High school/GED + 2 years of manufacturing or operations work or military experience OR Associate's + 6 months of manufacturing or operations work or military experience Preferred Qualifications: Bachelor's degree in Science or Engineering Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc. Knowledge of Single-use-Systems CFR and Regulatory knowledge Mechanical ability/expertise Basic statistical mathematical skills Ability to interpret and apply GMP knowledge Understanding of analytical methods for manufacturing area Demonstrated technical writing capability Able to demonstrate project management skills and presentation skills Ability to understand, apply and evaluate basic chemistry, biology and physical principles Basic troubleshooting skills on production equipment Experience with Delta V Experience with lab equipment/testing Additional Information Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. All your information will be kept confidential according to EEO guidelines.
    $28k-41k yearly est. 10h ago
  • Advocacy Relations Director, Inflammation and Bone Business Unit

    Amgen 4.8company rating

    Amgen Job In Washington, DC Or Remote

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Advocacy Relations Director, Inflammation and Bone Business Unit** **What you will do** Let's do this! Let's change the world. In this vital role you will the Advocacy Relations Director for the Inflammation and Bone Business Unit (IBBU) is a key leader responsible for shaping and executing the patient advocacy strategy across a diverse and evolving therapeutic portfolio. In this role you will play a critical part in elevating the voices of patients and advocacy partners to shape solutions, address access barriers, and drive meaningful impact across both established and emerging therapeutic areas. You will oversee Amgen's long-standing relationships with patient communities in inflammation and bone while also identifying and cultivating new partnerships that support clinical development programs where unmet needs persist. Through strategic leadership, cross-functional alignment, and a deep understanding of patient insights, the Advocacy Director will ensure that the advocacy strategy is agile, inclusive, and aligned to Amgen's mission and business priorities. This is a remote position reporting to the Assistant Vice President, Patient Advocacy and Corporate Affairs. **Responsibilities:** **Strategic Leadership & Team Oversight** + Lead and develop the inflammation and bone advocacy team, including direct management of therapeutic areas leads. + Develop and execute an integrated advocacy strategy that aligns with corporate objectives and adapts to portfolio shifts and evolving patient needs. + Allocate resources dynamically to high-priority areas and ensure coordinated engagement across internal teams and external stakeholders. **Community Engagement & Access Support** + Partner with long-standing key patient advocacy organizations cultivating high-trust, compliant, partnerships to advance education, reduce access barriers, and support appropriate use of approved therapies. + Collaborate cross-functionally with medical, marketing, government affairs and alliance management, and communication teams to drive critical insights and amplify patient voices in shaping access and reimbursement strategies. + Represent Amgen in relevant external coalitions and forums to elevate the inflammation community's voice and needs. + Represent the patient perspective in internal forums and communications, ensuring organizational actions reflect community needs and values. **Clinical Development & Unmet Needs** + Identify and build relationships with emerging advocacy groups and communities in areas with limited existing engagement, particularly those related to pipeline and patient impact expansion products under clinical development. + Generate actionable insights through partnership to inform development, clinical trial recruitment, unmet needs, and future access strategies. + Work closely with clinical development teams to integrate patient and caregiver perspectives early in the product lifecycle. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The Advocacy professional we seek will have these qualifications. **Basic Qualifications:** Doctorate degree and 4 years of patient advocacy and/or healthcare policy experience **Or** Master's degree and 7 years of patient advocacy and/or healthcare policy experience **Or** Bachelor's degree and 9 years of patient advocacy and/or healthcare policy experience **Preferred Qualifications:** + 7+ years of progressive experience in patient advocacy, public affairs, healthcare strategy, or related fields, including demonstrated leadership of cross-functional or external engagement teams. + Proven track record of building and sustaining trusted relationships with patient advocacy organizations, community leaders, and individuals with lived experience. + Experience engaging advocacy partners across the full product lifecycle-from clinical development and trial design through regulatory milestones, access planning, launch, and post-approval engagement. + Understanding of the role patient perspectives play in shaping health policy, access, and clinical trial awareness. + Demonstrated success in competitive therapeutic areas (e.g., osteoporosis, asthma, atopic dermatitis, psoriasis,), with the ability to differentiate value narratives in crowded and dynamic environments. + Strategic thinker with the ability to align advocacy strategies to business priorities while staying grounded in patient insights and community needs. + Ability to build consensus across diverse advocacy voices. + Comfortable operating in ambiguous, fast-changing policy and payer environments, especially in the context of emerging or first-in-class therapies. + Excellent communication, storytelling, and influencing skills to elevate patient perspectives and inspire organizational action. + Recognized internally and externally for executive presence, sound judgment, and commitment to authentic, empathetic patient partnerships. + Understands the pharma/biotech business model, regulatory process & compliance guidelines. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Application deadline** Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $176k-231k yearly est. 10d ago
  • Manager Maintenance - Fill & Finish Operations (Night Shift)

    Amgen 4.8company rating

    Amgen Job In Puerto Rico Or Remote

    Career CategoryMaintenanceJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager Maintenance - Fill & Finish Operations What you will do Let's do this. Let's change the world! In this vital role, you will lead the Maintenance Section at the Formulation, Filling & Inspection Manufacturing Plant, ensuring operational reliability and regulatory compliance. As Maintenance Manager, you'll transform the Asset Management Strategy into impactful initiatives, drive key maintenance programs, and improve equipment uptime to meet production demands. You'll use CMMS to document and analyze maintenance activities, keeping the Plant audit-ready and continuously improving through Lean/6 Sigma methodologies. Specific responsibilities include but are not limited to: Develop and implement the Maintenance Vision and Strategy to align asset management and maintenance activities with operational goals. Supervise a multi-skilled team, managing workloads, training, performance evaluations, and ensuring adherence to GMP and Safety standards. Direct maintenance activities to ensure equipment reliability, compliance, and seamless support of production schedules, collaborating closely with Manufacturing and support teams. Oversee Preventive, Corrective, and Predictive Maintenance Programs, managing work order completion, performance metrics, and equipment history records to drive efficiency. Lead maintenance planning and scheduling, participating in weekly coordination meetings, including WCT meetings, to optimize workflow. Serve as Maximo CMMS gatekeeper, ensuring data accuracy and using insights for maintenance improvements and inventory management. Review and update SOPs, providing technical training and guidance to staff on compliance and industry standards. Ensure compliance within the areas, implementing safety protocols, managing permits and LOTO procedures, and maintaining an audit-ready environment. Lead continuous improvement initiatives within the Maintenance area, applying Lean/6 Sigma methodologies and Kaizen events. Handle Maintenance budget, sourcing materials cost-effectively, and overseeing Spare Parts inventory adjustments. Coordinate maintenance logistics during Plant Slowdown/Shutdown, acting as liaison with Engineering, Operations, and other functional teams to ensure efficient completion. What we expect of you We are all different! Yet, we all use our unique contributions to serve patients. The Manager Maintenance professional we seek is a strong leader with these qualifications. Basic Qualifications: Doctorate degree OR Master's degree and 3 years of maintenance experience in a GMP environment Or Bachelor's degree and 5 years of maintenance experience in a GMP environment Or Associate's degree and 10 years of maintenance experience in a GMP environment Or High school diploma / GED and 12 years of maintenance experience in a GMP environment And In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above. Preferred Qualifications: Technical academic background (Mechanical, Electronics, Electrical, or Instrumentation). Dynamic technical and managerial experience in Maintenance/Engineering within the Pharmaceutical or Biotechnology industry. Proved leadership and team-building skills, including staff coaching, mentoring, and development within a GMP-compliant environment, with knowledge of Lean/6 Sigma. In-depth knowledge of maintenance programs, predictive/preventive practices, and CMMS systems, with certifications in Reliability or Predictive Maintenance as a plus. Strong technical competence in equipment operation, validation processes, and compliance with cGMP, Safety, and regulatory standards. Demonstrated organizational skills with a focus on continuous improvement, able to manage 24/7 operations and adapt to shifting priorities. Excellent communication and presentation skills in Spanish and English, both written and verbal, with proficiency in MS Office and technical reporting. What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and an annual site shutdown Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .
    $71k-111k yearly est. 60d+ ago
  • Specialty / Senior Specialty Representative - Bone Health - Philadelphia, PA North

    Amgen Inc. 4.8company rating

    Amgen Inc. Job In Philadelphia, PA Or Remote

    JOB ID: R-216545 ADDITIONAL LOCATIONS: US - Pennsylvania - Philadelphia WORK LOCATION TYPE: Field Worker DATE POSTED: May. 28, 2025 CATEGORY: Sales SALARY RANGE: - Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. SPECIALTY REPRESENTATIVE/SENIOR SPECIALTY REPRESENTATIVE What you will do Let's do this. Let's change the world. In this vital role you will be the connection to our customers by providing clinical knowledge of our products to medical professionals and helping them navigate the complex payer environment. We are actively searching for a Specialty Representative or Senior Specialty Representative to deliver on our commitment to serve patients. The Specialty Representative/Senior Specialty Representative acts as the primary customer contact and is responsible for implementing marketing strategy and promoting Amgen products as led by the District Manager. Responsibilities include: * Provide current and comprehensive knowledge of Amgen's products and effectively communicate the clinical benefits to medical professionals to drive appropriate utilization of the products * Perform as a sales leader to achieve territory sales by delivering branded sales messages, conducting planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets through both in-person and virtual engagement * Develop relationships to service and manage accounts which may include: customizing discussions and customer interactions based on understanding of customer needs, ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts * Provide feedback on marketing strategy, analyze business effectiveness of sales activities and territory analysis, and develop territory plans with the District Manager * Partner with other colleagues to share best practices and seek to learn and grow as a Specialty Representative/Senior Specialty Representative * Demonstrate passion for our products and sustain that passion through the entire sales cycle while always building our brand and never losing sight of how we serve patients * Uphold Amgen Values: Be Science-Based; Compete Intensely and Win; Create Value for Patients, Staff, and Stockholders; Be Ethical; Trust and Respect Each Other; Ensure Quality; Work in Teams; Collaborate, Communicate, and Be Accountable What we expect of you We are all different, yet we all use our unique contributions to serve patients. The sales professional we seek is a motivated individual with these qualifications. Basic Qualifications (Specialty Representative): * Bachelor's Degree OR * Associate's degree and 4 years of Sales experience OR * High school diploma/GED and 6 years of Sales experience Basic Qualifications (Senior Specialty Representative): * Bachelor's degree and 3 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related * OR * Associate degree and 6 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related * OR * High school diploma / GED and 8 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related Preferred Qualifications: * Sales, marketing and/or clinical experience within pharmaceutical, biotech, diagnostics, healthcare insurance, pharmacy services, healthcare medical device or medical supply industries * Some experience and/or pre-graduate sales training and/or proven track record of successful leadership under pressure preferred for Specialty Representative * 3 years+ experience preferred for Senior Specialty Representative * Product or hospital sales experience in the areas of oncology, cardiology, inflammation, nephrology, dermatology, rheumatology, neurology, endocrinology, hepatology, gastroenterology, bone health, respiratory, hematology, or infectious diseases; and the diseases and treatments involved with these specialties * Advanced influencing and relationship-building skills with a focus on sales outcomes * Local Market knowledge * Bachelor's degree in Life Sciences or Business Administration * Adaptability with our Core Competencies: Sales Planning and Organizing; Leveraging Business, Industry, and Technical Knowledge; Communicating with Impact; Driving for Results; and Cultivating Internal and External Relationships. This position is open to candidates of various backgrounds and experience levels. The role level/title will be chosen based on the candidate's match to basic qualifications and level of experience required for this geography. What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The annual base salary range for the Specialty Representative opportunity in the U.S. is $91,720 - $108,152. The annual base salary range for the Senior Specialty Representative opportunity is the U.S. is $121,379 - $149,742. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: * Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans and bi-annual company-wide shutdowns * Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Apply Now
    $121.4k-149.7k yearly 11d ago
  • Associate Training & Development

    Amgen Inc. 4.8company rating

    Amgen Inc. Job In Juncos, PR Or Remote

    JOB ID: R-215649 LOCATION: US - Puerto Rico - Juncos WORK LOCATION TYPE: On Site DATE POSTED: May. 27, 2025 CATEGORY: Training Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate Training and Development What you will do Let's do this. Let's change the world. In this role, you will act as a liaison between our organization and client groups, performing comprehensive needs assessments to identify and address specific training requirements that improve the skills and knowledge of our employees. Key Responsibilities: * Assess and communicate client training needs by working directly in their environment, ensuring delivery of tailored solutions including cGMP and regulatory training. * Deliver comprehensive training for new hires and transfers, facilitating their transition from training to work environment while serving as a Subject Matter Expert (SME) in specific technical areas. * Provide technical support and mentorship on compliance, regulatory issues, and manufacturing processes, as a resource/trainer on manufacturing support tasks and reporting of procedural deviations. * Review and revise documentation (equipment logs, SOPs, batch records) and may initiate Non-Conformance records as needed. * Support team operations in a 24/7 format, including extended hours and weekends as required, while organizing and prioritizing tasks to meet project timelines. * Collaborate with cross-functional teams to ensure training programs align with business objectives. * Deliver training to clients, which may involve hazardous materials and equipment. Provides on-the-job training and technical guidance to team members. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Associate Training and Development professional we seek is an individual contributor with these qualifications. Basic Qualifications: Bachelor's degree OR Associate's degree and 4 years of Training and Development experience Or High school diploma / GED and 6 years of Training and Development experience Preferred Qualifications: * Experience delivering training in a biotech or pharmaceutical manufacturing environment * Strong organizational and time management skills with high attention to detail and ability to follow written procedures * Excellent communication and presentation skills, with ability to facilitate groups and work effectively with staff at all levels * Bilingual fluency in English and Spanish (both verbal and written technical communication) * Ability to work independently with minimal direction while prioritizing tasks effectively * Strong customer service orientation with skills to identify client performance needs * Solid proficiency with Microsoft Office applications (Outlook, Word, Excel, PowerPoint) and other software applications, e.g. Smartsheet. * Physical capability to set up training environments (lifting to 35 pounds). * Good documentation practices and understanding of Amgen's business culture What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans and an annual site shutdown * Flexible work models, including remote work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Apply Now
    $34k-41k yearly est. 12d ago
  • Specialist, North American Operations, Scheduling, and Cell Logistics

    Bristol Myers Squibb 4.6company rating

    Remote or Seattle, WA Job

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible. The Position: The Operations Specialist, Scheduling and Cell Logistics will be responsible for monitoring patient treatment schedules for the manufacturing of BMS's clinical and commercial autologous cellular immunotherapy products. They will resolve real-time operational issues related to transportation, manufacturing, distribution, and administration. The primary duty of the Operations Specialist, Scheduling and Cell Logistics is to execute day-to-day operations (>= 95% of time). Participation in projects and working groups is a growth opportunity as operations permit, considering performance and alignment with development plan. Position is office-based in Seattle, WA with in-office attendance required a minimum of 60% of the time. Remote work must be performed at home with consistent office setup and internet access, as extensive work at computers and phones is essential to job function. Overtime may occasionally be required as assigned. Weekend and holiday on-call support is required as assigned. Travel is possible and will not exceed 10%. International travel will not exceed once per year. Responsibilities: Act as initial and primary scheduling point of contact for apheresis centers, manufacturing sites, couriers, and other logistics partners Create and maintain patient schedules in coordination with apheresis centers, manufacturing sites, treatment sites, and third-party logistics Monitor collection, delivery, transportation, and manufacturing activities Troubleshoot and develop plans of action for issues throughout the patient journey Interact with internal and external stakeholders over the phone and email Ensure a positive end-to-end customer experience Execute escalations and facilitate product returns and product replacements Input and maintain transactional data related to patient schedules within BMS's scheduling system Document feedback from customers and partners as received Actively participate in tactical and other meetings as assigned Facilitate daily operations activities and meetings including shift turnover on rotating basis Provide real-time scheduling portal support to external users Monitor and triage requests and issues within the case management system Provide on-call and holiday support as assigned Comply with applicable SOPs, work practices, and other documentation Accountable for individual performance Execute project tasks as assigned Execute working groups tasks as assigned Qualifications and Experience Bachelor's degree or 3 years of work experience Work experience in customer service, call center operations, patient services/navigator, account management, logistics, or supply chain preferred Highly self-motivated, self-aware, and professional Salesforce CRM experience a plus Able to work independently and in groups Flexible in responding to quickly changing business needs Exceptional customer service orientation Skilled at managing tense situations and de-escalation Eager to work with teams from other regions and cultures Able to share workspace for independent and collaborative work Strong sense of ownership and accountability Fluent reading, speaking, and writing skills required in English The starting compensation for this job is a range from $69,000 - $86,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the geographic location where work is performed. Final, individual compensation is decided commensurate with demonstrated experience. For more on benefits, please visit our BMS Careers Site. Eligibility for specific benefits listed therein may vary based on job and location. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $69k-86k yearly 7d ago
  • Rare Disease Field Access Specialist

    Pfizer 4.5company rating

    Remote Job

    The Rare Disease Field Access Specialist is a non-promotional, field-based commercial role that supports patient access to Rare Disease portfolio products. The FAS is a subject-matter expert on reimbursement, access, and coverage issues affecting our Rare Disease products. The FAS proactively engages with HCPs and their staff on Hub-enrolled cases around matters relating to reimbursement, access and coverage to assist patients with access to our Rare Disease products. The FAS will serve as the primary point of contact for HCP offices regarding the status of individual patients seeking access or reimbursement support through our respective product hubs. This individual will report directly to, the Access & Reimbursement Regional Director for the **West Region** . The Rare Disease Field Access Specialist will perform their duties while adhering to all Pfizer policies and compliance standards. **ROLE RESPONSIBILITIES** + Be the primary point-of-contact with HCPs/office staff for access-related communication relating to patients prescribed our products and/or enrolled in the product Hub, including helping to resolve reimbursement and coverage questions; + Provide education to HCPs/office staff regarding local/regional payer landscape, payer coverage and formulary change updates, payer policies (e.g., prior authorization, step edits, specialty pharmacy coverage), Hub activities, and patient support and financial assistance offerings. + Coordinate as appropriate with other Pfizer colleagues. + Maintain a detailed understanding of the patient access journey within our distribution channels and requirements at each stage, keeping abreast of regional/provider changes in access requirements and inform any changes to appropriate internal stakeholders. + Provide HCPs with information on how patients may apply to the Pfizer PAP, and direct to the product Hub for further information. + Provide HCPs with information on how patients may enroll in Pfizer copay programs, and direct to the respective hub for further information. + Understand defined distribution networks. + Utilize approved systems and platforms to compliantly manage assigned cases. + Work cross functionally with PAC and CENCORA Access Counselors to optimize the patient access journey. + Understand Buy & Bill. All activity will be performed consistently with Pfizer's mission, values, and policies and under the direction of their immediate supervisor the Access & Reimbursement Regional Director. This person must exhibit strong communication, organizational, and management skills in order to be effective with a host of diverse stakeholders. + Must conduct themselves with the utmost discretion and confidentiality. + Must adhere to strict company compliance guidelines and procedures. + Effectively and compliantly communicate with stakeholders to adopt ideas, actions, or positions through logical and engaging messages without direct authority. + Effectively link customer insights to the offerings and resources to address patient access barriers. + Build trust through follow up and knowledge of the access journey. + Demonstrate excellence in responsible business communication both written and spoken. **Knowledge & Skill Sets Desired** + Excellent communication skills, both written and verbal. + Exceptional relationship building skills: Trust, Integrity, Empathy, Patience. + Deliver meaningful & concise presentations. + Outstanding collaboration and networking abilities. + Exceptional attention to detail and organizational skills. + Ability to work in a team environment. + Rare Disease HCP Community. + Government & Rare Disease Payment Systems. + Adherence to Regulatory and Compliance Standards. + Ability to travel - Approximately **70%** with some weekends as appropriate to cover industry related events. **BASIC QUALIFICATIONS** + Bachelor's degree required. + Minimum 7-10 years pharmaceutical industry experience typically within the fields of pharmaceutical sales and/or coding and reimbursement. + Valid US driver's license and a driving record in compliance with company standards. **PREFERRED QUALIFICATIONS** + Minimum 3-5 years of medical billing or insurance claim management experience, preferably within the Pharmaceutical/ Biopharmaceutical sectors, Provider/Carrier Networks, or Government Agency. Reimbursement and Access experience is a must. Strong understanding of Rare Disease Reimbursement, Government Payment Systems, Provider/Carrier Networks, Co-Pay Assistance Programs, and knowledge of the Rare Disease policy dynamics that exist in the Rare Disease Community. + Experience demonstrating exceptional communication and presentation skills, strategic planning and success in implementation of this plan to bring a return on investment. This individual must also have demonstrated leadership and success at working across internal boundaries and be able to collaborate with multiple stakeholders to coordinate various unique objectives. + Demonstrated ability to work in a highly regulated environment and adhere to strict company compliance guidelines and procedures. Proven track record of collaborating broadly with a diverse range of customers, clients, and stakeholders. Training in and experience in responsible business communication both written and spoken. **Other Job Details** + **Last Date to Apply:** June 19th, 2025 + Territory covers: Alaska, Idaho, Oregon & Washington + Must live in one of the states listed. + Preference to live close to an airport. The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. **Sunshine Act** Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. **EEO & Employment Eligibility** Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Sales Operations & Admin
    $63k-93k yearly est. 2d ago
  • QC Associate - Medical Device

    Eli Lilly and Company 4.6company rating

    Remote or Indianapolis, IN Job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The QC Associate is primarily responsible for assessing, establishing, and supporting quality systems within the Indianapolis Device Manufacturing (IDM) QC organization per applicable Lilly Quality Standards (LQS) and Global Quality Standards (GQS). This role provides daily quality control support, and guidance for the IDM QC Laboratory involving laboratory operations, testing practices, analytical equipment, and test method development impacting the Device Quality Control Laboratory. Responsibilities: Provide Quality Control technical support for the IDM QC laboratory related to device testing for commercial and development product (e.g., design verification, process validation, stability, and batch release testing). Support Event Management through roles of originator, executor, and investigator of quality observations/deviations and analytical investigations impacting the QC laboratory using root cause analysis. Support Change Management through roles of originator and executor, primarily completing impact analysis tasks and implementation steps. Serve as author, periodic reviewer, and/or subject matter expert (SME) for applicable IDM QC laboratory procedures, processes, and equipment, including training of laboratory personnel. Timely review and approval of GMP laboratory data and documentation: protocols, methods, technical reports, procedures, sampling plans, and rework/retest/resample instructions. Perform comprehensive technical review of lot release testing data generated by the IDM QC lab. Implement, maintain, and/or enhance appropriate quality systems within IDM QC laboratory. Build and maintain working relationships with DDCS, PRD, TS/MS, Lilly final Device Assembly/ Packaging Sites, and Contract Manufacturers supporting batch release testing of Lilly product. Participate in new product design and pre-launch preparation projects to support device specification and test method development, laboratory equipment validation, and device testing. Participate in departmental process improvement activities (continuous improvement). Participate in regulatory agency and internal inspections. Play a key role in the harmonization of global methods and support of local and global lab issues. Develop and maintain knowledge of applicable regulations, LQS, and GQS requirements in order to network and influence Lilly's and the industry's application. Basic Requirements: Bachelor's degree in STEM discipline Minimum of 1 year of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e.g., cGMP, 21 CFR 820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL). Additional Preferences: Three or more years of experience in Quality (QA/QC), Technical Services (TS/MS), or Engineering Experience writing requirements documents (e.g., procedures) and developing training materials Analytical thinking skills and attention to detail Ability to mentor and train others - share learning Excellent teamwork and interpersonal skills Strong critical thinking and problem solving skills with an ability to apply rationale Self-management / motivated and ability to multi-task Strong verbal and written communication skills in English Computer literate in Teams/Sharepoint, Windows, and Microsoft applications (Outlook, Excel, Word) Experience with parenteral products, dry products, or devices Experience with analytical lab equipment (e.g., Zwick, CADI, MicroVu) and LIMS systems (e.g., Darwin, SmartLab, LabVantage) Previous experience with method development Experience with documentation management systems (e.g., Veeva/Quality Docs) and CAPA systems (e.g., TrackWise), especially related to analytical investigations Demonstrated knowledge and application of federal regulations as applicable to the pharmaceutical industry and related quality systems, especially related to lab systems and data integrity Additional Information: The position is day shift on site Monday-Friday. Occasional after-hours and holiday coverage may be required. The position supports limited (1-2 days per month) work from home. Limited travel may be required for OUS and domestic travel ( Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $63k-162.8k yearly 21h ago
  • Thought Leader Liaison, KRYSTEXXA, Northeast (New York, Boston)

    Amgen Inc. 4.8company rating

    Amgen Inc. Job In New York, NY Or Remote

    JOB ID: R-217264 ADDITIONAL LOCATIONS: US - New York - New York ADDITIONAL LOCATIONS: US - Massachusetts - Boston WORK LOCATION TYPE: Field Worker DATE POSTED: Jun. 05, 2025 CATEGORY: Sales & Marketing Operations SALARY RANGE: 195,353.00 USD - 226,875.00 USD Let's do this. Let's change the world. In this critical role, you will focus on building and maintaining relationships with external opinion leaders and large medical centers treating uncontrolled gout across rheumatology and nephrology. The TLL role is a commercial, field-based, customer-facing role focused on the identification and cultivation of relationships with both leading and emerging key opinion leaders (KOLs) as well as leading the development of key customers and speakers. You will be a critical member of the Brand Team and will coordinate closely with field sales and field medical. It will be important for you to drive alignment to the KRYSTEXXA brand objectives and strategic imperatives. Additionally, you will be expected to bring insights to help shape the brand strategy, anticipate market events and champion cross functional collaboration with internal team members. In this role, you will report into the TLL Director for KRYSTEXXA and will be part of the Rare Disease Business Unit. * Significant customer-facing time, building relationships with existing and new thought leaders for involvement in current and future commercial activities * Creates local peer-to-peer strategies in coordination with national and regional strategic marketing and sales business plans. * Liaise with sales and marketing to ensure thought leader concerns/needs are addressed in a timely and thorough manner * Collaborates closely with the Amgen advocacy team to develop relationships with key physician and patient organizations * Creates and executes short-term and long-term KOL engagement plans. * Captures, synthesizes and shares key thought leader insights to help shape brand strategy and prepare for future life cycle management and competitor entry into the marketplace * Identifies evidence gaps across product and disease education through appropriate thought leader discussions and podium observations. * Disseminate thought leader insights to broader Amgen stakeholders, including marketing, sales, market access to drive development of new strategies and tactical approaches and to ensure a comprehensive view of market trends is integrated into overall planning * Coordinate leadership interactions at all assigned national/regional, state society conferences * Initiates and pursues opportunities to involve Amgen in meaningful programs with thought leaders to ensure Amgen is strategically and strongly positioned in the market * Assists with speaker events, including selection of speakers, training for speakers and reviewing current speaker programs ensuring consistent messaging and compliant execution * Collaborates with marketing team on peer-to-peer programs including speaker training programs and contributes to ongoing refinement of U.S. speaker bureau * Contributes to content development by providing customer insight and perspective, increasing program impact & relevance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is a person with these qualifications. Basic Qualifications: Doctorate degree and 2 years of marketing, sales, relevant clinical or medical experience Or Master's degree and 4 years of marketing, sales, relevant clinical or medical experience Or Bachelor's degree and 6 years of marketing, sales, relevant clinical or medical experience Or Associates degree and 10 years of marketing, sales, relevant clinical or medical experience Or High school diploma / GED and 12 years of marketing, sales, relevant clinical or medical experience Preferred Qualifications: * 3-5 years of experience working in rheumatology, nephrology or Rare Disease in customer facing roles (sales, district manager, medical affairs/MSL, marketing opinion leader management, etc.) * Experience developing and executing HCP key customer strategies * Relationships with rheumatology or nephrology opinion leaders * Biotech/pharmaceutical industry experience required * Strong relationship management capabilities * Ability to understand scientific literature and key publications * Excellent organizational skills with keen attention to detail and the abilities to take ownership of issues and to work independently with confidence and to meet deadlines * Excellent verbal and written communication skills * Ability to work well with all levels of employees and demonstrate strong collaboration skills * Ability to work in a fast-paced, dynamic environment * Professional, proactive demeanor * Strong interpersonal skills Travel Requirements: * Requires approximately 50-65% travel by air or car is regularly required * Individual must reside within territory boundaries given travel requirements * Willingness to work some evenings and select weekends is required * Located near a hub airport is recommended Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com Application deadline Amgen anticipates accepting applications until June 16, 2025 however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates. Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provideda reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Amgen is a Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients. Apply Now
    $109k-149k yearly est. 3d ago
  • Diagnostic Regulatory Affairs Manager

    Amgen 4.8company rating

    Amgen Job In Thousand Oaks, CA Or Remote

    divh2bCareer Category/b/h2Regulatoryh2/h2h2bJob Description/b/h2pbHOW MIGHT YOU DEFY IMAGINATION?/b/pp You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. /ph2bCompanion Diagnostic Regulatory Affairs Manager/b/h2h2bLive/b/h2pbWhat you will do/b/pp Let's do this. Let's change the world. In this vital role, you will support establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in vitro diagnostics (IVDs)/companion diagnostics (CDx's). /ph2bKey responsibilities:/b/h2ulliProviding critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning and decision-making/lili Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities/lili Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development teams and joint project teams with diagnostic partners/lili Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions (e. g. PMA, 510(k), IDE)/lili In collaboration with diagnostic partners and internal teams, prepare for and conduct meetings with regulatory agencies. /lili Review and approval of key diagnostic regulatory submissions to CDRH and global health authorities (as agreed with diagnostic partners) and corresponding therapeutic dossiers. /lili Interacting with international regulatory colleagues and diagnostic partners to determine best practices and least burdensome regulatory paths toward development and global registration activities/lili Assessing the impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development and registration activities, respectively/lili Regulatory support of due diligence activities of external CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed/lili Manage Regulatory Information Management System (e. g. VeevaVault) and support the department in regulatory document management activities. /lili Maintain regulatory SharePoint site and document archive/intelligence database(s)/li/ulh2bWin/b/h2pbWhat we expect of you/b/pp We are all different, yet we all use our outstanding contributions to serve patients. The versatile expert we are looking for plays a crucial role as a collaborative partner and possesses these credentials. /ph2bBasic Qualifications:/b/h2h2spanMust have in depth knowledge of regulatory document management systems including content management and archival, such as VeevaVault. /span/h2p/pp Doctorate degree/ph2Or/h2pMaster's degree and 3 years of Health Agency or Med-Device or Regulatory experience/ph2Or/h2pBachelor's degree and 5 years of Health Agency or Med-Device or Regulatory experience/ph2Or/h2pAssociate's degree and 10 years of Health Agency or Med-Device or Regulatory experience/ph2Or/h2pHigh school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience/ph2bPreferred Qualifications:/b/h2ulliMS Degree/lili Degree in Regulatory Affairs, Life Sciences, or Engineering/lili6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations/lili8 plus years of experience in medical device and/or IVD/CDx industry/li/ulh2bThrive/b/h2pbWhat you can expect of us/b/pp As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. /pp Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:/pulli Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. /liliA discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan/lili Stock-based long-term incentives/lili Award-winning time-off plans and bi-annual company-wide shutdowns/lili Flexible work models, including remote work arrangements, where possible/li/ulh2bApply now/b/h2pbfor a career that defies imagination/b/pp Objects in your future are closer than they appear. Join us. /ph2bcareers. amgen. com/b/h2p/pp Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position/pp/pp Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. /pp We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. /pp style="text-align:inherit"/pp style="text-align:inherit"/pp style="text-align:inherit"/p. pb Salary Range/b/p112,345. 00 USD - 143,224. 00 USD/div
    $111k-145k yearly est. 60d+ ago
  • Corporate Automation Utilities Engineer

    Eli Lilly and Company 4.6company rating

    Remote or Indianapolis, IN Job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Lilly is at a critical juncture as we tool up to realize the potential of our product pipeline. We are building new processing capabilities around the world, and emphasizing emerging, innovative processing technologies, such as continuous processing and advanced biotech platforms. Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune five hundred company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is in the process of expanding manufacturing with three new sites in Lebanon, Indiana and recent acquisition and expansion at Kenosha, Wisconsin. In addition, Lilly announced that four new pharmaceutical manufacturing sites would be built in the United States that includes both active pharmaceutical ingredients (API) and parenteral manufacturing for future injectable therapies (Drug Product). The Corporate Automation Utilities Engineer is a senior automation position that will lead the design and delivery of major capital projects as part of Lilly's manufacturing expansion. This role is intended to lead one or more project workstreams for the design of key utility systems including the central utilities plant, clean utilities (WFI, Clean Steam), and Building Automation Systems. This role will partner with A&E firms and other Lilly consultants to develop conceptual, basic, and detailed design packages. The role will also collaborate with selected suppliers on build, FAT, and site startup activities. This role will be part of Lilly's Global Process Automation & Control Engineering (GPACE) team in Corporate Engineering. GPACE provides automation, measurement, and process control solutions. GPACE is a technical resource for training, standards, capital project delivery, and Lilly's standard automation platforms. GPACE's primary customers are global manufacturing and development sites, Corporate IT, and peer groups such as Global Facilities Delivery (GFD). The Corporate Automation Utilities Engineer role requires the candidate to be flexible on location and have the ability to travel both US and OUS. Key Objectives/Deliverables: Be a champion for health & safety, diversity & inclusion, ethics, and compliance. Partner with Global Facilities Delivery, Global Groups, OEM's, Engineering firms, and site teams to design, install, and qualify key site utility platforms including clean steam, water for injection, purified water systems, and building automation systems. Lead and support the development of statements of work and automation supplier and integrator selection. Lead and support delivery strategies, quality assessments, and CSV and C&Q verification plans. Collaborate with site automation leadership to integrate resources into the project team. Assist with site hiring and capability building. Collaborate with other corporate engineering groups and Lilly IT to develop delivery strategies and execution plans. Coach and mentor others. Basic Requirements: Bachelor's in Engineering (preferably Electrical, Mechanical, Computer, or Chemical) or a related science field. Minimum 3 years of Process Automation / Process Control experience. Experience with site utility platforms including but not limited to: clean steam. water for injection, purified water systems, and building automation systems. Experience in pharmaceutical or related manufacturing. Experience with Rockwell Automation Platforms. Experience in Commissioning and Qualification. Additional Skills/Preferences: Excellent verbal and written communications skills. Strong analytical and critical thinking skills. Collaborative skills with operations, process engineering, and other project & manufacturing team members. Integration of OT and IT platforms. Project management experience. Technical knowledge in process instrumentation. Ability to influence without authority. Ability to clarify and simplify complex issues. Strong trust building with peers and leaders. Other Information: The Automation Utilities Engineer role will initially start out in Indianapolis, IN but will transition full time to a project site location. There can be some accommodation for remote work until the project location is determined. There will also be project travel associated with the role, both US and OUS to support design reviews, FAT's, and other project related activities. Travel would not typically exceed 25%. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $76,500 - $167,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $76.5k-167.2k yearly 21h ago
  • Field Clinical Specialist - Shockwave (Seattle, WA)

    Johnson & Johnson 4.7company rating

    Remote or Santa Clara, CA Job

    * Job title Field Clinical Specialist - Shockwave (Seattle, WA) * Function MedTech Sales * Sub function Clinical Sales - Hospital/Hospital Systems (Commission) * Category Analyst, Clinical Sales - Hospital/Hospital Systems (Commission) (P4 - E24) * Date posted Jun 03 2025 * Requisition number **********W * Work pattern Fully Remote This job posting is anticipated to close on Jul 31 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: MedTech Sales Job Sub Function: Clinical Sales - Hospital/Hospital Systems (Commission) Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America, Seattle, Washington, United States of America Job Description: Johnson & Johnson is hiring for a Field Clinical Specialist for Shockwave Medical Inc. located in Seattle, WA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Field Clinical Specialist is a visible position that will provide case support to physicians within certain territories. Case support will be done on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) technology. The Field Clinical Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. Case support may be required to support other territories at certain times. Essential Job Functions * Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. * Effectively meet the needs of internal and external customers with a sense of urgency and drive. * Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms. * Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders. * Partner with other clinical research colleagues to meet business needs in the field including site re-training, data collection for timely database locks and resolution of critical issues. * Administrative activities including training to procedures, manage territory travel and budgets. * Other duties as assigned. Qualifications - External * Minimum Bachelor's Degree in business, science, nursing or related fields, or equivalent experience. * Minimum 2 years' experience directly supporting interventional or surgical procedures within a hospital setting OR, 1 year of industry, hospital-based life sciences, sales support experience. Cardiovascular industry experience preferred but not required. * Working knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. * A history of effective collaboration with regulatory agencies through clinical studies and market releases. * Product knowledge including product vigilance and medical device reporting. * High attention to detail and accuracy. * Computer skills (MS Office products, word processing, spreadsheets, etc.). * Finance and budgeting knowledge. * Good prioritization and organizational skills. * Excellent critical thinking skills. * Excellent influencing and negotiation skills. * High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people. * Entrepreneurial "hands-on" experience. Pro-active and "can do" attitude. * Ability to consider and accept feedback and suggestions for continuous improvement. * Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such. * Effective written, verbal and presentation skills with all levels of customers and management. * Ability to work in a fast-paced environment while managing multiple priorities * Operate as a team and/or independently while demonstrating flexibility to changing requirements. * There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) * Significant travel >50% of time requiring the employee to be effective in a remote manner. * Employee may be required to lift objects up to 40lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space. Pay Transparency: Additional Information: * The base pay range for this position is $100,000. * The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. * This position is eligible for a car allowance through the Company's Fleet program * Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. * Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). * Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. This job posting is anticipated to close on March 31,2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit *******************. The anticipated base pay range for this position is : Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
    $100k yearly 5d ago
  • Project Coordinator, Clinical Pharmacology & Pharmacometrics

    Johnson & Johnson 4.7company rating

    Remote or Spring House, PA Job

    * Job title Project Coordinator, Clinical Pharmacology & Pharmacometrics * Function Business Support * Sub function Administration & Secretarial * Category Analyst, Administration & Secretarial (P4 - E24) * Date posted Jun 06 2025 * Requisition number R-017520 * Work pattern Hybrid Work This job posting is anticipated to close on Jun 14 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Business Support Job Sub Function: Administration & Secretarial Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: Johnson & Johnson is recruiting for a Project Coordinator, Clinical Pharmacology & Pharmacometrics (CPP) located in Spring House, PA, Titusville, NJ or Raritan, NJ. This position may require up to 10% travel. Per our J&J Flex Policy, the expectation for this position is to work in the office 3-4 days per week and work from home 1-2 days per week. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine The Project Coordinator will independently and proactively support activities and processes managed by the CPP Business Operations team, while also providing logistics and administrative support to the Clinical Pharmacology & Pharmacometrics Organization. Principal Responsibilities The position enables operational excellence in areas of communications, procurement, compliance, knowledge management, and administrative support. Excellent collaboration skills across multiple functions and all levels of Clinical Pharmacology & Pharmacometrics (CPP) are required to accomplish departmental activities in local, virtual, and global environments. Primarily, the incumbent will serve as a lead or owner for assigned projects and/or processes; requiring an ability to lead best practices thinking and implementation within CPP, the use of sound judgment, discretion, attention to detail, and independent assessment for resolution of complex situations/problems. As the individual will act as a single point of contact for executive leaders on assigned projects and processes, he/she must be self-directed and can respond quickly to shifting priorities and accommodate multiple stakeholder requirements in order to make last minute changes and/or decisions without prior approval from assigned leaders. The incumbent will also spend a portion of their time supporting CPP leadership in managing calendars, travel, expense reporting, and contracting/purchase orders as needed. * Expertise: Demonstrates self-initiative, problem-solving, troubleshooting, and applied experience in multiple areas of project management, process improvement, business operations, and administrative support. Is effective in the use of computational tools and technology. * Communication: Demonstrates excellent written, oral presentation and interpersonal communication skills. Demonstrates the ability to collaborate and consult with partners across domains and teams. Translates operations concepts into actions effectively. * Resource Management: Support and identifying improvement opportunities for the resource management process (1-Supply, Onboarding, Offboarding) * Administrative: Supports the organization of meeting logistics and agendas that enable decision making and the alignment of CPP priorities to R&D priorities. Forms effective partnership with CPP Administrative Function, CPP-LT and business partners. * Process and Innovation: Supports the identification and implementation of process improvements. Suggests and helps evaluate and implement solutions that improve process and cost efficiencies. * Technology: Demonstrates proficiency in operational and communication platforms and MS Office Suite. * Collaboration: Works cross-functionally to identify and resolve issues. Cultivates internal, cross-functional partnerships and external relationships. Collaborates effectively with CPP colleagues and with external sourced partners to achieve results with a focus on improving communication, efficiency, and productivity. * Representation: Represents CPP Business Operations and occasionally Clinical Pharmacology & Pharmacometrics on cross-functional and inter-departmental teams or working groups. * Additional Responsibilities: * Manages multiple projects and internal stakeholders effectively. * Provide effective administrative support including complex travel arrangements, large and complex meeting coordination, contracting, and purchase order management. * Support the training compliance and inspection readiness goals for CPP staff through monitoring and communication. * Supports/leads communication activities internal to CPP and support external communications through emails, and electronic mediums, as well as occasionally in-person forums such as town halls. * Contributes to knowledge management content and systems including SharePoint. * Supports the identification, prioritization, tracking and reporting out of end-to-end processes or improvement initiatives. * Proactively identify areas for improvement and suggest solutions. Drive the implementation of best practices including change management. * Supports the execution of CPP and cross-functional sourcing strategies and vendor management. Principal Relationships: * Internal: CPP Business Operations, Statistics & Decision Sciences, Global Development, Human Resources, Finance and Procurement * External: Contracted Partners, Suppliers and Vendors, Scientific Societies. Education and Experience Requirements: * Bachelor degree (or equivalent) * 5 years relevant work experience * Excellent organization skills, excellent written and verbal communication skills. Excellent independent time management skills. Proven ability to plan and track deliverables and timelines. * Ability to effectively work with cross-functional teams in a matrix environment. * Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business. * In-depth experience with operating and communication platforms (SharePoint, MS Teams, Global Connect, eMarketPlace, Concur) * High proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook, Visio) * Proven performance and practical knowledge in administrative support and project management with matrixed responsibilities in the pharmaceutical industry is required. * Effective partnership with stakeholders at all levels in a global matrix environment. * Proactive and able to work independently with minimal supervision in interdisciplinary contexts and across teams. * Exercise good judgment, maintain confidentially and discretion as coming across sensitive information. * Flexibility in working hours occasionally required to effectively support global teams * Ability to travel between J&J sites both domestic and international at least 10% is required Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $63,000 - $100,000 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://*******************/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
    $63k-100k yearly 2d ago
  • Oncology Area Business Specialist (Hematology) - Upstate NY & CT- Johnson & Johnson Innovative Medicine

    Johnson & Johnson 4.7company rating

    Remote or Syracuse, NY Job

    * Job title Oncology Area Business Specialist (Hematology) - Upstate NY & CT- Johnson & Johnson Innovative Medicine * Function Pharmaceutical Sales * Sub function Sales - Oncology/Hematology (Commission) * Category Senior Analyst, Sales - Oncology/Hematology (Commission) (P6) * Location Syracuse / Hartford / Buffalo / United States of America * Date posted Jun 04 2025 * Requisition number R-017319 * Work pattern Fully Remote This job posting is anticipated to close on Jun 12 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Pharmaceutical Sales Job Sub Function: Sales - Oncology/Hematology (Commission) Job Category: Professional All Job Posting Locations: Buffalo, New York, United States, Hartford, Connecticut, United States, Syracuse, New York, United States Job Description: We are searching for the best talent for Oncology Area Business Specialist in Upstate NY & CT. About Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine This position within Portfolio Strategy & Execution Team, is part of the commercial organization at Johnson and Johnson Innovative Medicine. This role will be focused on optimizing hematology operational strategy and readiness for execution within Community accounts by educating and training accounts to maximize delivery of our products inclusive of practice economics and efficiency, payer landscape, and patient assistance. Key Responsibilities: * Collaborate with J&J Oncology field teams peers to build relationships with key stakeholders in community accounts * Educate and train staff on appropriate efficiency practices to support delivery of our products * Act as Responsible subject matter expert (SME) on the economic value story and key private and public payer changes that impact delivery process for our products for both inpatient and outpatient settings * Advise on patient affordability programs that are available to assist patients financially. * Partner with J&J local teams to ensure staff in accounts have been trained using company approved materials to deliver pharmaceutical products in a safe and efficient manner * Partner with J&J local teams to train appropriate clinical staff re: technical aspects of product delivery, administration, monitoring, and adverse event management and reporting. * Assist members of sales force (e.g., Oncology Specialists, District Managers) in all aspects of product promotion, including but not limited to product access, pull-through and reimbursement. * Support patient care and transition between sites of care to optimize patient adherence and ensure a mix of viable sites of care are available in the local marketplace. * Mentor doctors and staff on practice management including but not limited to, how to develop and implement an end-to-end delivery of J&J products including overall operations management, scheduling, staffing, pre-authorization, reimbursement, capacity management, inventory management, and management/efficiencies. * Help Community sites remove operational barriers with hematology products (EHR/Order Sets updated, transitions of care, partnerships). * Drive the pull through of brand resources like professional education * Implement EHR patient identification pull through and embed patient access & affordability resources into Community EHR systems in partnership with other Field teams * Approach each customer from a total account management perspective, by leveraging resources appropriately, collaborating with business partners and accurately articulating the value proposition for the customer. Required: * A minimum of a bachelor's degree or equivalent experience in practice management * A valid driver's license issued in one (1) of the fifty (50) United States * The ability to travel, up to 60% of the time * Reside in the geography and/or willing to relocate to it Preferred: * BA/BS or degree in related field. * Work related experience in Oncology. * Pharmaceutical sales experience * Experience working with field teams (Key Account Manager, Account Managers, Oncology Clinical Educator, etc.). * Practice management & operations experience or applicable experience in a similar role leading a total office call, inclusive of practice management, operations, and systems management experience Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. #RPOAMS The anticipated base pay range for this position is : $108,000-$173,650 annually Additional Description for Pay Transparency:
    $108k-173.7k yearly 4d ago
  • Biostatistics Director (Hybrid)

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Remote or Boston, MA Job

    As a Director Biostatistics at Vertex, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may lead to innovative medical breakthroughs. The Biostatistics Director will independently perform highly scientific statistical functions in support of the company's Immunotherapies program area on new and complex issues, creating alternative approaches to achieve desired results if needed. In addition, the Director provides independent strategic and technical contributions. The incumbent should possess an excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. This position is hybrid, with a work schedule that allows for 2 days per week remote-based work and 3 days per week in the Boston Seaport office. (Relocation assistance is available). Key Duties and Responsibilities: * Directs one or more projects including multiple clinical trials, observational studies, or real world data (RWD) investigations. Also includes presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards. * Mentors project team members and promotes effective team operation and cross-functional collaboration. * Possesses an expert understanding of modern drug discovery and development processes. * Represents Biostatistics as a member of cross functional teams, providing strategic input and expert technical guidance to elicit meaningful and/or productive outcomes. Sets the technical and scientific directions of the project(s). * Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results. * Leads collaboration with statistical programming and other functions to ensure high quality and technically sound delivery of TFLs. * Leads or contributes to external interactions with regulators, payers, review boards, etc. * Authors or co-authors methodological or study-related publications and posters. * Leads implementation of innovative designs and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others. * Contributes to departmental working group efforts on key various technical and operational issues. * Independently undertakes new and highly complex issues requiring advanced analytical thought. * Completes work in a resourceful, self-sufficient manner; conceptualizes alternative, and at times untested, approaches to achieve desired results. * Maintains and expands in-depth knowledge of related disciplines with a drug developer mindset. Knowledge and Skills: * Project management and project team oversight * Expertise with SAS and R statistical software * Demonstrated expertise in advanced/complex statistical methods used in drug development * Deep skill in critical thinking and logical problem-solving * Excellent written and verbal communication skills with the ability to influence opinions of peers and managers * Excels in a team environment * Collaborates well with non-statisticians and can effectively explain complex concepts to non-technical audiences * NDA/MAA experience and direct dealings with USA/European regulators. Education and Experience: * Ph. D. in Statistics or Biostatistics. * Typically requires 10 years of experience with a Ph.D. #LI-AR1 #LI-Hybrid Pay Range: $196,000 - $294,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $97k-132k yearly est. 10d ago
  • Principal Clinical Safety Specialist - Shockwave Reducer

    Johnson & Johnson 4.7company rating

    Remote or Santa Clara, CA Job

    * Job title Principal Clinical Safety Specialist - Shockwave Reducer * Function Product Safety * Sub function Drug & Product Safety Operations * Category Senior Analyst, Drug & Product Safety Operations (P6) * Date posted May 20 2025 * Requisition number R-004188 * Work pattern Fully Remote This job posting is anticipated to close on Jun 13 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Product Safety Job Sub Function: Drug & Product Safety Operations Job Category: Professional All Job Posting Locations: New Brighton, Minnesota, United States of America, Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Principal Clinical Safety Specialist- Shockwave Reducer to join our team located in New Brighton, MN. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Principal Clinical Safety Specialist will have primary responsibility for study or program oversight, ensuring all aspects of safety are conducted according to procedure and in a compliant manner. The Principal Clinical Safety Specialist may oversee one or more studies, assuming ownership for study-specific requirements. This may include special projects, process development, vendor oversight, audit participation, and providing advisory to the clinical and post-market surveillance teams. In addition, the Principal Clinical Safety Specialist will be responsible for providing backup support for adverse event collection and processing, safety monitoring, maintenance of study-specific Safety Management Plans, and participation in writing and/or reviewing safety sections of clinical study documents. This may also include management of Clinical Events Committee(s) and Data Safety Monitoring Board(s). Essential Job Functions * Assumes wholistic responsibility for safety management and monitoring for one or more clinical studies, including: * Establishment of end-to-end safety documentation system; development of study-specific plans, procedures and data entry guidelines * Compliance with pre-market regulatory reporting of Serious Adverse Events (SAEs) and Device Deficiencies (DDs) * Assurance of high-quality safety data collection * Provision of direction and guidance to safety vendor(s), escalating vendor management issues as appropriate * Management of Clinical Events Committees (CEC) and Data and Safety Monitoring Boards (DSMB) * Serving as liaison and advisor to the post-market surveillance team to resolve complaints-related issues * Use of appropriate medical and regulatory judgement in escalating any safety concerns * In addition, the Principal Clinical Safety Specialist may provide support for any of the following: * Review, evaluation of, and tracking of incoming adverse events (AEs) including follow-up of ongoing events * Collaboration with sites/monitors/Contract Research Organization (CRO) to ensure comprehensive information is available for full review of adverse events * Drafting or review of SAE narratives * Distribution and notification of AEs to appropriate teams and clinical sites, as needed * Liaison for safety-related questions from Clinical Affairs, CRO, monitors, Field Clinical Specialists, post-market quality, surveillance, etc. * Verification of consistency and compliance in application of protocol definitions for adjudication outcomes * Providing input to the development and management of study related documents including clinical protocols, case report forms, monitoring plans, study manuals, and other study tools related to adverse event reporting and definitions * Assistance with preparation of safety reporting for annual reports, clinical study reports, investigator brochure updates, and other documents as required * Maintains knowledge of current FDA, ISO, competent authority, IRB, REB, and EC regulatory rules and policies affecting AE reporting * Assists in training of study personnel regarding the adverse event definitions per protocol * Collaborates on additional Clinical Affair's activities, as required * Other duties as assigned Requirements * RN or equivalent healthcare experience, with Bachelor's degree preferred * Minimum 10+ years' experience in clinical safety or combined clinical safety/post-market vigilance experience, with prior clinical research experience preferred * Experience in cardiovascular disease preferred * Experience with medical device clinical studies preferred * Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology * Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.) * Good prioritization and organizational skills * High attention to detail and degree of accuracy * Familiarity with electronic data capture (EDC) systems * Operates both as a team and independently, with adaptability to changing requirements * Experience coordinating, prioritizing, setting timelines, and multi-tasking. * Expertise with medical device regulations and compliance guidelines for clinical studies including ISO 14155, 21 CFR 812, EU MDR, and other relevant guidance documents * Position requires approximately 10% travel Pay Transparency: * The anticipated salary range for this position is $121,000 - $194,350 * The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. * Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. * Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). * This position is eligible to participate in the Company's long-term incentive program. * Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Additional information can be found through the link below. ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $121,000 - $194,350 Additional Description for Pay Transparency:
    $66k-85k yearly est. 20d ago
  • Sr. Field Clinical Engineer - Shockwave Medical

    Johnson & Johnson 4.7company rating

    Remote or Santa Clara, CA Job

    * Job title Sr. Field Clinical Engineer - Shockwave Medical * Function R&D Operations * Sub function Clinical/Medical Operations * Category Experienced Analyst, Clinical/Medical Operations (P5) * Date posted May 12 2025 * Requisition number R-013331 * Work pattern Fully Remote This job posting is anticipated to close on May 30 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Operations Job Sub Function: Clinical/Medical Operations Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Sr. Field Clinical Engineer - Shockwave Medical (Remote) to join our team. The position is FULLY REMOTE and can sit anywhere in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials. In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success. Essential Job Functions * Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. * Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms. * Provide clinical and technical support for key study investigators and clinical leaders at assigned sites. * Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues. * Administrative activities including training to procedures at site level. * Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals. * Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools. * Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked. * Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals. * Partner with assigned physician advisors to create and deliver recruitment strategies. * Partner with vendors that support recruitment activities. * Other duties as assigned. Requirements * Bachelor's Degree in a scientific field of study or equivalent work experience. * Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital. * Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials. * Thorough knowledge of Good Clinical Practice (GCP) is required. * Ability to attain and maintain hospital credentials. * Ability to work in a fast-paced environment while managing multiple priorities. * Operate as a team and/or independently while demonstrating flexibility to changing requirements. * Experience with electronic data capture (EDC) systems. * Must have excellent verbal and written communication skills. * High attention to detail and accuracy. * Able to manage multiple project teams with guidance * Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.) * Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America. * May be required to lift up to 25 pounds. Pay Transparency: * The anticipated salary range for this position is US: $89,000 - $143,750 / Bay Area: $103,000 - $165,600 * The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. * Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. * Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). * This position is eligible to participate in the Company's long-term incentive program. * Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Additional information can be found through the link below. ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : $89,000 - $143,750 Additional Description for Pay Transparency:
    $103k-165.6k yearly 8d ago
  • Technical Sales Specialist, MedTech Digital

    Johnson & Johnson 4.7company rating

    Remote or Santa Clara, CA Job

    * Job title Technical Sales Specialist, MedTech Digital * Function Sales Enablement * Sub function Sales Strategy * Category Experienced Analyst, Sales Strategy (P5) * Date posted May 29 2025 * Requisition number R-013019 * Work pattern Fully Remote This job posting is anticipated to close on Jun 30 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Sales Enablement Job Sub Function: Sales Strategy Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America : About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of MedTech surgery? Ready to join a team that's reimagining how we heal? Our MedTech Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech. We are searching for the best talent for a Technical Sales Specialist position. This position is Fully Remote. Job Description: We are seeking a dynamic and self-motivated Technical Sales Specialist to join our sales team. The ideal candidate will have a strong understanding of connected devices, software, cloud, and how to sell connected devices with associated software into hospitals. This person will be responsible for providing technical support to sales representatives and customers, communicating our connected medical devices and software and their IT specs, answering technical questions that arise from customers, and coordinating with relevant JJMT teams to fill in IT/IS questionnaires that come from customers and answer customer questions related to those questionnaires. The role will focus on North America sales but will also support APAC as needed and will coordinate closely with the EMEA team to ensure that processes followed are globally consistent. You will be responsible for: * Offer rapid, knowledgeable responses to customer technical inquiries during the sales cycle, showcasing problem-solving abilities and in-depth product expertise. * Collaborate with Regional Sales Managers and Account Managers to support their sales motion with customers by partnering with them for presentations and Q&A with customer stakeholders that have any questions about connectivity in the device and/or software * Seek, analyze, and act on customer feedback, liaising with service, engineering and research teams to answer and review IT/IS questionnaires and provide feedback to product as needed based on customer feedback * Serve as a subject matter expert, aiding team members in reducing customer escalations and contributing to cost containment through expert guidance. * Work closely with cross-functional teams, including Professional Education, Customer Success, R&D, and Clinical Engineering, to foster client satisfaction and encourage repeat business. * Ensure customer feedback during the sales process is quickly and accurately communicated to the appropriate internal teams, expediting resolutions. * Remain informed of industry advancements, evidencing a commitment to continuous professional development and market leadership. Qualifications / Requirements: Education: * Bachelor's degree in engineering or a related domain. Advanced degree preferred Required: * Minimum of 2+ experience in Medtech, healthcare sales, SaaS, or technical roles. * Demonstrated experience in medical technology or technical roles, with a focus on robotics or connected medical devices. * Proficiency in the understanding of robotics, human physiology, and medical equipment, with the ability to apply this knowledge in a sales context. * Excellent communication and presentation skills, capable of explaining complex technical information in an easily understandable format. * Strong negotiation skills and business acumen, with a proven track record in a competitive sales environment. * Flexibility for extensive travel (up to 50%) to meet with clients and attend events. * Proficient in the use of CRM software and sales analytics tools to track client interactions and sales progress. Preferred Skills & Experience: * Experience with connected medical devices and their use in OR's * Experience selling connected devices into hospitals * Knowledge of articulating cloud-based infrastructures, EHR interfaces, network diagrams & data flows * Knowledge of software architectures to protect PHI, data encryption, and data de-identification * Knowledge of hospital network connectivity and cybersecurity protection protocols * Experience with navigating hospital data security questionnaires and managing relevant stakeholders Other Requirements: * Ability to travel (up to 50%) to meet with clients and attend events. The anticipated base pay range for this position is $89,000 - $143,750 California Bay Area - The anticipated base pay range for this position is $103,000 - $165,600 This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. For additional general information on Company benefits, please go to: - ********************************************* This job posting is anticipated to close on 3/17/25. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. * #RAD-CM * #Li-Remote The anticipated base pay range for this position is : The anticipated base pay range for this position is $89,000 - $143,750 Additional Description for Pay Transparency: California Bay Area - The anticipated base pay range for this position is $103,000 - $165,600
    $103k-165.6k yearly 9d ago
  • Senior Director - Construction and Engineering Services Capital Procurement

    Eli Lilly and Company 4.6company rating

    Remote Job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Reports To: AVP of Global Capital and Real Estate We are seeking a highly skilled and experienced Senior Director - Construction and Engineering Services Capital Procurement to lead our company's engagement with Construction Managers, Design Builders, EPC/EPCMs, and Architectural and Engineering firms. This role is pivotal in negotiating deals and strategically developing our supply base to support our ambitious $27B capital portfolio plan. The ideal candidate will have deep experience negotiating construction service agreements with engineering and construction firms. This position requires extensive experience with mega industrial projects. In this role, you will work closely with management from design, construction, project controls, contracts, and legal to enable delivery of new life sciences manufacturing sites at scale. The primary focus is on the planning and execution of the construction procurement and commercial activities. Key roles and responsibilities include negotiating critical commercial terms for Lilly's portfolio of capital projects, developing and executing a regional business strategy, complementing the category strategy which positions Lilly's cost, technology, and availability requirements in a dynamic environment. Key Responsibilities: Lead and manage procurement strategies for a portfolio of large-scale capital projects across functions and geographic areas, ensuring alignment with the company's strategic goals. Develop and maintain strategic relationships with key suppliers, including Construction Managers, Design Builders, EPC/EPCMs, and Architectural and Engineering firms. Negotiate and finalize billion-dollar contracts for mega industrial projects, ensuring the best value and terms for the company. Drive supplier development initiatives across a portfolio of capital projects while growing and developing our supply base. Collaborate with internal stakeholders to understand project requirements and ensure procurement strategies meet these needs. Influence senior management and other internal/external partners on key decisions and outcomes Monitor market trends and find opportunities for cost savings and efficiency improvements. Ensure compliance with all relevant regulations and standards in procurement processes. Provide leadership and mentorship to the procurement team, fostering a culture of excellence and continuous improvement. Your Basic Qualifications: Bachelor's degree in Supply Chain Management, Construction Management, Engineering, Architecture, or related degree. Minimum of 10 years of experience in construction commercial/cost control, supply chain management, contracts management, or construction project management. Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. What You Should Bring: Consistent track record of negotiating and leading billion-dollar contracts and supplier relationships. Deep understanding of construction contracting, pricing/methods of measurement, and supplier development on industrial projects. Exceptional commercial acumen and strategic thinking abilities. Strong leadership and team management skills. Excellent communication and interpersonal skills. Ability to work in a fast-paced, dynamic environment and lead multiple priorities. Experience in a senior procurement role within a large, complex organization. Knowledge of industry best practices and emerging trends in capital procurement and construction contracting, particularly in mega industrial projects. Professional certifications such as CPSM, CIPS, or PMP. Why Join Us: Opportunity to lead and shape the procurement strategy for a significant capital portfolio. Work with a dynamic and innovative team committed to excellence. Competitive salary and benefits package. Career growth and development opportunities. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $150,000 - $220,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $150k-220k yearly 21h ago
  • Software Engineer, Product Security

    Johnson & Johnson 4.7company rating

    Remote or Santa Clara, CA Job

    * Job title Software Engineer, Product Security * Function R&D Product Development * Sub function R&D Software/Systems Engineering * Category Experienced Engineer, R&D Software/Systems Engineering (ST5) * Date posted Jun 05 2025 * Requisition number R-009770 * Work pattern Fully Remote This job posting is anticipated to close on Jul 31 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: R&D Software/Systems Engineering Job Category: Scientific/Technology All Job Posting Locations: Santa Clara, California, United States of America Job Description: About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech Remote work options may be considered on a case-by-case basis and if approved by the Company. #Li-Hybrid We are searching for the best talent for a Cybersecurity Software Engineer, to be in Santa Clara, CA. Purpose: We are looking for an early in career Software Engineer who would help improve the software cybersecurity of our product. The position requires understanding of cybersecurity controls and deliverables, knowledge of C++ preferably in a Linux environment, and the ability to work closely with other software engineers as well as multi-functionally. The successful candidate is self-motivated, curious, and has the desire to bring the essential and best in class cybersecurity controls and implementations into the medical field. You will be responsible for: * Designing, implementing, and testing software solutions for cybersecurity controls. * Defining software cybersecurity requirements and detailing the software design of the product based on cybersecurity requirements. * Performing software code reviews and design reviews with a cyber-lens. * Performing periodic risk assessment of security vulnerabilities in software for the product by identifying and analyzing software vulnerabilities * Developing recommendations to mitigate security risks in product software. * Developing product software using C++ and scripting languages such as bash in an FDA regulated environment. * Actively collaborating with cross-functional product partners including Product Security, systems, test and service teams. * Adhering to organization and product level quality processes outlined in the Quality Management System. Qualifications / Requirements: * BS or equivalent in Computer Science, Computer Engineering, or equivalent field. * 2+ years of software development and testing experience. * 2+ years of experience with software development using C++. * 1+ years of experience implementing software controls for product/IOT cybersecurity. * Knowledge of cybersecurity concepts such as encryption, authentication and authorization. * Working knowledge of Linux Ubuntu and understanding security controls provided by the operating system. * Experience of working with multi-threaded applications. * Familiarity with shell scripting languages including bash. Preferred Skills & Experience: * MS/MEng in Cybersecurity, or similar field. * Familiarity with CI/CD tools and Dev-Sec-Ops tools and processes. * Experience working with Agile methodology as an individual contributor. * Experience analyzing security risks from sources such as penetration testing, threat modeling, vulnerability management etc. Other Requirements: * Must be at least 18 years of age. * Ability to travel up to 10% domestic US and Internationally, with overnight stay. * Ability to work onsite at the J&J office in Santa Clara, CA. The expected base pay range for this position is $89,000 to $143,750. For the California Bay Area, the anticipated base pay range for this position is $103,000 to $165,600. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year. * Sick time - up to 40 hours per calendar year. * Holiday pay, including Floating Holidays - up to 13 days per calendar year. * Work, Personal and Family Time - up to 40 hours per calendar year. For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on 4/30/25 The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. * Software Engineering - #RADSW * Product Security - #RADPS * #Li-Hybrid
    $103k-165.6k yearly 3d ago

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Amgen may also be known as or be related to AMGEN INC, Amgen, Amgen Inc, Amgen Inc. and Applied Molecular Genetics (1980–1983).