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  • Senior Payroll Specialist

    Moderna 4.8company rating

    Moderna job in Cambridge, MA or remote

    The Role: Moderna is seeking a highly skilled and motivated Senior Payroll Specialist to support a broad range of activities within the Payroll function. This role is responsible for managing all aspects of U.S. (multi-entity, multi-state) and Canadian (multi-entity) payroll operations, including coordination of related equity transactions. The Senior Payroll Specialist will serve as a trusted payroll expert, driving operational excellence, compliance, and continuous process improvement across all U.S. and Canadian payroll activities. The ideal candidate will have advanced proficiency in Workday Payroll, with a proven track record of delivering accurate, timely, and compliant payroll results. Strong attention to detail, integrity in handling sensitive data, and commitment to process optimization, compliance, and data accuracy are essential to success in this role. Here's What You'll Do: Process and oversee end-to-end payroll for U.S. (multi-entity, multi-state) and Canadian (multi-entity, multi-province) employees, ensuring accuracy, timeliness, and compliance with all applicable laws and internal policies. Leverage ADP SmartCompliance expertise to manage wage and tax compliance and administration across the U.S. and Canada. Validate, reconcile, and audit payroll data from multiple systems (Workday and vendor outputs) to ensure data integrity before processing and funding. Partner with HR, Benefits, Accounting, and Finance to align payroll processes, support audits, and ensure a seamless employee pay experience. Collaborate with Global Compensation and Global Mobility teams to support expatriate shadow payroll, cross-border reporting, and payroll-impacting events (transfers, relocations, and repatriation). Coordinate with HR, Finance, and Legal to fulfill documentation and compliance requests, and assist with ad-hoc payroll-related reporting. Monitor the payroll inbox and resolve employee inquiries, including timesheet validation, in a timely and professional manner. Work closely with outsourced payroll providers and vendors to ensure service quality, compliance, and adherence to SLAs. Manage state and provincial agency correspondence and remain current on wage, tax, and reporting regulations to ensure ongoing compliance. Support quarter-end and year-end payroll activities, including reconciliations, adjustments, and preparation of tax documents (e.g., W-2s, T4s, RL-1, ROE). Assist with quarterly and annual audits and maintain accurate payroll documentation in compliance with SOX and internal controls. Maintain and update payroll procedures and SOPs to ensure audit readiness and consistency with corporate policies. Collaborate with HRIS and IT to test and implement Workday payroll configuration changes, integrations, and system updates. Contribute to process improvement initiatives, driving efficiency, accuracy, and scalability within payroll operations. Serve as a subject matter expert in payroll systems, compliance, and best practices to enhance governance and employee experience. Here's What You'll Need (Basic Qualifications): Minimum of 5 years of hands-on payroll experience, including U.S. (multi-entity, multi-state) and Canadian (multi-entity, multi-province) payrolls, with demonstrated technical expertise and strong regulatory knowledge. Proficiency in Workday Payroll for end-to-end processing and ADP SmartCompliance for wage and tax compliance across the U.S. and Canada. Strong analytical, organizational, and problem-solving skills with a high level of attention to detail. Proficiency in Microsoft Excel and general payroll reporting and reconciliation tools. Effective communication and collaboration skills, with experience working cross-functionally with HR, Finance, and external vendors. Proven ability to process and reconcile complex payrolls accurately and on time. Strong understanding of U.S. federal, state, and Canadian provincial payroll regulations, tax compliance, and reporting requirements. Demonstrated ability to manage sensitive employees and compensation data with the highest degree of integrity and confidentiality. Work authorization in the United States without the need for future sponsorship. Here's What You'll Bring to the Table (Preferred Qualifications) Bachelor's degree in Accounting, or a related field. Certified Payroll Professional (CPP) or equivalent certification. 7+ years of progressive payroll experience in a multi-entity, multi-state U.S. payroll environment and has exposure to Canadian payroll or equity processing. Advanced experience with Workday reporting, integrations, and system testing. Proven track record of process improvement and automation initiatives within payroll operations. Experience supporting quarter-end, year-end, and audit activities, including reconciliations and tax documentation. Strong knowledge of equity and bonus payroll processing and related taxation. Demonstrated ability to thrive in a fast-paced, high-growth environment and adapt to evolving business needs. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna 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 or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. #LI-CK1 -
    $89.9k-143.8k yearly Auto-Apply 60d+ ago
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  • Specialist, Quality Control

    Moderna 4.8company rating

    Moderna job in Norwood, MA or remote

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. The Quality Control Specialist will support cGMP QC routine testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, leading method transfers, qualification activities, quality records (e.g. Change Controls, CAPAs, ECs, Investigations), and ensuring compliance with cGMP standards. The individual will teach and train analysts on technical concepts and methods and act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development. This is an on-site position. Here's What You'll Do Your key responsibilities will be: Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities. Support bioassay routine testing for raw materials, drug substance and drug product. Lead special projects as Bioassay SME. Perform on the job training. Write/revise SOPs, protocols, and reports. Troubleshoot issues related to equipment, laboratory procedures and assay performance Establish and maintain a safe laboratory working environment. Analyze and trend data as assigned Review Data Own and manage Quality records (i.e. investigations, change controls, CAPAs) Ensure compliance with cGMP documentation and regulatory guidelines. Accountable for all mandatory training and assigned tasks. Provide support during audits and collaborate on continuous improvement initiatives. Establish and maintain a safe laboratory working environment. Additional duties may be assigned. The key Moderna Mindsets you'll need to succeed in the role: “We obsess over learning. We don't have to be the smartest - we have to learn the fastest.” Your success in this role will depend on a constant drive to expand technical expertise, especially in complex assays and evolving quality control technologies. You'll adapt quickly to new data, regulatory changes, and innovation opportunities - including leveraging AI-enabled lab tools and automation. “We behave like owners. The solutions we're building go beyond any job description.” As a Specialist, you won't just complete tasks - you'll own the quality systems and improvements you're a part of. You'll actively shape workflows, mentor peers, and elevate the lab's performance, embodying full accountability for results and impact. Here's What You'll Need (Basic Qualifications) Education: BS in a relevant scientific discipline STEM degree with minimum 5 years of experience in a cGMP laboratory, with hands-on experience in Mammalian cells, Cell-based Assays, ELISA and Protein Analysis. RFT (Right First Time) in execution. Method validation/qualification cell-based assays, or protein analysis methods. Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes) Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet Experience with laboratory equipment calibration and maintenance. Ability to work effectively in a fast-paced, cross-functional matrix environment. Working knowledge and application of FDA, EU, ICH guidelines, and regulations. Experience providing technical training. Experience in technical writing. This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Here's What You'll Bring to the Table (Preferred Qualifications) A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna 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 or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1 -
    $74k-118.4k yearly Auto-Apply 6d ago
  • Oncology Imaging & Biomarker Strategy Lead

    Regeneron Pharmaceuticals, Inc. 4.9company rating

    Boston, MA job

    A leading biotechnology firm is seeking a Clinical Imaging Scientific Director for Oncology to lead imaging strategy and execution in clinical trials. The ideal candidate will have a PhD and over 10 years of experience in clinical imaging, particularly in oncology, with significant expertise in PET imaging and regulatory engagement. This role requires collaboration with research teams and overseeing imaging project implementation, contributing significantly to oncology drug development. Comprehensive benefits are offered to eligible employees. #J-18808-Ljbffr
    $104k-139k yearly est. 3d ago
  • Associate Director, Marketing

    Gilead Sciences, Inc. 4.5company rating

    Remote or Santa Monica, CA job

    We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR‑T cell therapies have changed the paradigm, but we're not finished yet. Join Kite and help shape where our business and medical science goes next. You'll play a key role in the development of new cancer therapies and in creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Job Description We are seeking a highly motivated individual to join us as the Associate Director of Marketing focused on the LBCL indication. The Associate Director will play an important role in developing HCP promotion, cultivating an integrated LBCL strategy, and implementing a cross‑functional tactical plan to support and grow Yescarta's LBCL indication. This person will report to the head of LBCL within Kite's US Commercial Department. Key Responsibilities of the Associate Director of Marketing - Yescarta include: Develop and optimize brand strategies and marketing tactics using market research and analytics, ensuring accurate փmeasurement of promotional tactics. Oversee the development and execution of annual brand plans, including long‑term strategic imperatives and short‑term tactical priorities. Champion cross‑functional alignment and ensure seamless execution across key stakeholders. Develop and deliver differentiated brand and marketing concepts and materials, aligning with the brand's purpose, target customer needs, and industry trends. Collaborate with the Promotional Review Committee (PRC) to create compliant and effective promotional tactics and ensure their effective implementation. Formulate, develop, and implement strategic plans while escalating market challenges and barriers to leadership, proposing appropriate solutions. Exhibit a “roll up your sleeves” attitude, demonstrating the ability to follow through on projects within tight timelines. Adapt and thrive in an ambiguous, transformational environment. Demonstrate leadership excellence in project management, effectively managing multiple projects and priorities, including agency collaboration and budget management. Travel domestically up to 50%. Basic Qualifications Advanced degree (PharmD, PhD, or equivalent) with 5+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Master's Degree知 2+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Bachelor's degree with 10+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Associate Degree and 12+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR High Schoolandaş Diploma/GED and 14+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing. Preferred Qualifications MBA or other advanced business degree. 8+ years of pharmaceutical or biotechnology experience. Experience in marketing research and / or pharmaceutical sales. Prior hematology / oncology or cell therapy experience, with in‑depth knowledge and experience in franchise‑specific market preferred. Ability to leverage data to conduct analyses and use complex analytical tools to drive decisions. Demonstrated excellence in project management and effectively managing multiple projects / priorities. Ability to successfully work with external agencies, including advertising, public relations and medical education vendors to develop programs and materials. Familiarity with marketing fundamentals, strategy, sales and commercial policies and practices. Compensation & Benefits The salary range for this position is: $177,905.00 心 $230,230.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligibleеспублик for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Equal Employment Opportunity Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual yenye orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the влияет-era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. Location & Remote Work Job Level: Associate Director Remote Type: Onsite Required Job Type: Full‑time Location: Santa Monica, CA #J-18808-Ljbffr
    $177.9k-230.2k yearly 2d ago
  • Senior Autoimmune Immunology MSL - Field Leader

    Johnson & Johnson 4.7company rating

    Boston, MA job

    A leading healthcare firm is seeking a Senior Medical Science Liaison based in the Boston area. This role involves providing scientific information to healthcare providers and requires strong experience in immunology. Candidates should have a PharmD, PhD, or MD with at least 3 years in related fields. The position emphasizes relationship-building and territory planning, with a travel requirement of up to 70%. Competitive compensation and benefits are offered. #J-18808-Ljbffr
    $106k-137k yearly est. 2d ago
  • Senior Medical Science Liaison, Dermatology (Boston Metro)

    Johnson & Johnson 4.7company rating

    Boston, MA job

    Johnson & Johnson Innovative Medicines is recruiting for a Senior Medical Science Liaison, Dermatology to be based in the Boston, MA territory. This field‑based clinical role focuses on providing balanced, objective scientific information and education to health care professionals, building strong relationships with opinion leaders, and supporting company research initiatives. The position requires significant travel (estimated 80%) and collaboration across internal and external teams. Responsibilities Develop and execute a strategic territory plan, including in‑person and virtual engagements with health care providers and key opinion leaders. Respond to scientific queries and provide evidence‑based data, integrating real‑world evidence to inform clinical practice. Coordinate and support investigator‑initiated research, including site identification, issue resolution, and meetings. Lead at least one scientific or strategic project in Immunology, identifying educational gaps and elevating team knowledge. Provide regional support to enhance sales training initiatives and improve field personnel competencies. Maintain accurate administrative requirements (expense reporting, activity documentation) and comply with regulatory and health‑care guidelines. Qualifications Advanced medical degree (PharmD, PhD, MD, NP, PA) with a minimum of 3 years of relevant therapeutic area clinical experience. At least 3 years of MSL or related pharmaceutical experience, including significant presentation experience. Strong communication, stakeholder engagement, and scientific dissemination skills. Valid U.S. driver's license with a clean record and ability to travel 75‑80% of the time. Residence within the assigned Boston, MA territory. Preferred Knowledge of dermatology or related immune‑mediated disorders. Proficiency with Microsoft Office (Word, Excel, PowerPoint) and remote collaboration tools. Prior experience collaborating with medical affairs, R&D, or field teams. Salary & Benefits Base salary range: $137,000 to $235,750 per year. Eligible for an annual performance bonus and company vehicle through the Fleet Program. Benefits include medical, dental, vision, 401(k) retirement plan, short‑ and long‑term disability, and paid time off. Travel Estimated travel: 80% within the Boston region, with occasional out‑of‑region visits. Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer committed to diversity and inclusion. 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 protected characteristics. #J-18808-Ljbffr
    $137k-235.8k yearly 1d ago
  • Principal Research Associate, Analytical Development

    Moderna 4.8company rating

    Moderna job in Norwood, MA or remote

    The Role: Reporting to the Head of the Product Characterization group, the individual in this role will coordinates characterization and comparability studies to support advancement of Moderna's pipeline, including commercial products. The incumbent should be familiar and have hands-on experience with most of the routine biochemical and biophysical characterization techniques used for RNA structural characterization, including mass spectrometry, spectroscopy, calorimetry, liquid chromatography, ELISA, light scattering and next generation sequencing. Demonstrated writing skills are required for protocol drafting and report compilation. Polished communication skills are essential considering that the incumbent will regularly interact with other RAs and Scientists within the Analytical Development, Analytical Technical Operations and Process Development teams. The individual will present scientific findings/results internally or externally. The individual will also evaluate new technologies, optimize methods and write methods SOPs. Here's What You'll Do: Draft testing protocols and compile characterization reports in support of regulatory filings Coordinate sample generation and sample submissions for partner groups Execute testing for various characterization assays including calorimetry, spectroscopy, light scattering and next generation sequencing Perform data analysis and data trending utilizing good documentation practices Record and communicate findings, present results at internal or cross-functional meetings Write/Revise SOPs related to job function Collaborate with other members within the with R&D departments throughout the company Perform general laboratory support activities including equipment maintenance and housekeeping Be accountable for project success and results delivery Here's What You'll Bring to the Table: BS with at least 4 years of industry experience, or MS with at least 2 years of industry experience (Biophysics, Chromatography, Biochemistry, Molecular Biology, or related science), Experience in performing biophysical characterization with focus on mRNA structural characterization Experience with spectroscopy and calorimetry Excellent writing and documentation skills Excellent interpersonal and collaborative skills Ability to work independently and effectively in a highly dynamic environment This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna 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 or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-CK1 -
    $89.9k-143.8k yearly Auto-Apply 60d+ ago
  • Global Safety Medical Director - Hematology/Oncology

    Amgen 4.8company rating

    Remote job

    Career CategorySafetyJob 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. Global Safety Medical Director - Hematology/Oncology What you will do Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed. Validate safety signals and lead safety signal assessments Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.) Prepare/review core and regional risk management plans including additional risk minimization measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Prepare/review safety sections of new drug applications and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications: Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Experience in the study/research and/or treatment of Oncology disease states 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. . Salary Range 243,245.00 USD - 319,267.00 USD
    $129k-182k yearly est. Auto-Apply 60d+ ago
  • Technician II, Command Center

    Moderna 4.8company rating

    Moderna job in Norwood, MA or remote

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. This individual contributor role is critical to maintaining uninterrupted facility operations at our Norwood campus. You will be responsible for monitoring, operating, and responding to conditions involving building and utility systems across Moderna sites via centralized digital platforms. Acting as the primary interface for communication and escalation during all shifts, this role is essential to ensuring operational continuity and safety across the network. With a strong foundation in system navigation, alarm management, and maintenance coordination, you will serve as the nerve center of facilities communication, fielding calls and facilitating rapid issue response. The position also involves physical inspections and routine maintenance tasks, making it a hands-on, systems-aware, and communication-focused role. If you're technically adept, calm under pressure, and thrive in an environment where every alert matters-you'll find purpose here. Here's What You'll Do Your key responsibilities will be: Monitor and operate Building Management Systems (BMS) to oversee critical utilities and infrastructure across Moderna sites. Respond to alarms and abnormal conditions using BMS, Central Monitoring Systems (CMS), and other digital platforms. Manage incoming calls to the command center, triage information, and escalate appropriately across departments. Ensure continuous 24/7/365 command center coverage, managing effective shift turnovers and preparing detailed passdown reports. Perform preventive maintenance tasks using the Computerized Maintenance Management System (CMMS). Handle process gas system oversight: monitoring quantities, ordering replacements, managing empty cylinders, and changing out as needed. Your responsibilities will also include: Record and track pH neutralization chemical additions and flow totalizer data. Respond to utility system faults or alarms and perform immediate investigation or escalation. Monitor off-hours Building Management System alarms from remote sites and initiate necessary actions. Conduct building rounds to verify operational efficiency, safety, and system integrity. Support effective coordination with Facilities, EHS, and Operations teams during incidents and planned activities. Contribute to documentation and reporting processes that enhance situational awareness and compliance. The key Moderna Mindsets you'll need to succeed in the role: “We behave like owners. The solutions we're building go beyond any job description.” As the first responder to infrastructure issues across Moderna campuses, you'll own the command center's performance and its ability to safeguard uptime, utilities, and operational communication. “We digitize everywhere possible using the power of code to maximize our impact on patients.” This role relies on digital mastery-from interpreting BMS alarms to entering data into CMMS and reporting systems-ensuring Moderna's platform is secure, efficient, and continuously improving. Here's What You'll Need (Basic Qualifications) Experience with building management systems and critical utilities operations. Strong communication skills for effective coordination and issue resolution. Ability to manage multiple tasks and prioritize effectively in a dynamic environment. Familiarity with CMMS systems, particularly Maximo. High school diploma or equivalent; additional technical certifications or vocational training is preferred. Military training equivalent of above is acceptable. Strong troubleshooting and problem-solving skills, with the ability to analyze complex issues and develop effective solutions. Proficient in reading and interpreting technical manuals, blueprints, and schematics. Excellent communication and interpersonal skills, with the ability to effectively communicate technical information to team members and stakeholders. Physical stamina and ability to perform manual labor. Minimum of 3 years of proven experience in maintaining and troubleshooting clean utilities systems in a pharmaceutical or similar regulated environment. At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Here's What You'll Bring to the Table (Preferred Qualifications) In-depth knowledge of utility systems, including HVAC, electrical, plumbing, and mechanical systems. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $53,500.00 - $85,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna 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 or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1 -
    $53.5k-85.6k yearly Auto-Apply 8d ago
  • Undergrad Intern - Inclusive Global Health and Impact (Summer 2026)

    Amgen 4.8company rating

    Remote job

    Career CategoryCollege JobJob 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. Undergrad Intern - Inclusive Global Health and Impact (Summer 2026) What You Will Do Let's do this. Let's change the world. This internship will be approximately 12 weeks and includes both project-based and experiential learning. The intern will be an integral member of the Amgen Inclusive Global Health and Impact (IGHI) Team, which is dedicated to embedding impact at every step of the value chain-from molecule to market-by uniting science, strategy, and multi-sector partnerships As a member of Amgen's IGHI Team, your work will be highly collaborative across multiple teams and levels within Amgen, including Representation in Clinical Research (RISE), Access to Health (ATH), and Health Impact. Additionally, you will have the chance to work cross-functionally with Research & Development, Corporate Affairs, Government Affairs, Health Equity, Advocacy Relations, Diversity, Inclusion & Belonging, and others. You will be uniquely responsible for one or more key projects that will advance the IGHI mission, including the following: Developing a project charter to map out objectives and identify key stakeholders, timelines, and deliverables Leveraging your analytical, leadership, communication, and interpersonal skills to work in teams, identify problems, conduct research, develop recommendations through qualitative and quantitative analysis, and deliver final projects Presenting your deliverables/findings through various forums including an intern-wide poster session and a final readout to executive management You will also be engaged in learning activities, networking with colleagues across the company, and enjoying full access to Amgen's Employee Resource Groups What We Expect of You We are all different, yet we all use our unique contributions to serve patients. The collaborative individual we seek is hard-working with these qualifications: Basic Qualifications: Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria: 18 years or older Currently enrolled in a full-time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent Completion of one year of study from an accredited college or university prior to the internship commencing Enrolled in a full-time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university Must not be employed at the time the internship starts Student must be located in the United States for the duration of the internship OR co-op Preferred Qualifications Pursuing a degree in Health Sciences, Psychology, Sociology, Communications, Business Administration, Public Health or a similar field Strong written and verbal communication skills Strong interest in public health, community health, social sciences, health equity, health policy, health communications, DEI (diversity, equity and inclusion), and/or other related fields Strong organization and time management skills 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 base pay range for this opportunity in the U.S. is $24.70 - $28.30 per hour. Build a network of colleagues that will endure and grow throughout your time with us and beyond. Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. Participate in executive and social networking events, as well as community volunteer projects. Apply now and make a lasting impact with the Amgen team. careers.amgen.com Please search for Keyword R-231691 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. Sponsorship Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed. 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. . Salary Range -
    $24.7-28.3 hourly Auto-Apply 41d ago
  • Director, Corporate Counsel - Privacy / Transactions

    Regeneron Pharmaceuticals 4.9company rating

    Cambridge, MA job

    Regeneron Pharmaceuticals is seeking a highly experienced transactions attorney for a pivotal role to serve as the liaison to the Regeneron Data Privacy Office. This position will act as a privacy expert within the Transactions & Contracts team offering guidance to colleagues on privacy law and ensuring that privacy provisions are seamlessly integrated into our contracts. The position involves drafting, reviewing, negotiating, and providing strategic counsel on a diverse portfolio of agreements across our innovative business units. Your expertise will be instrumental in advising the Transactions Team on complex privacy issues, requiring a deep understanding of life sciences, business transactions, and data privacy. We are looking for a candidate with exceptional drafting and negotiation skills, and a proven track record of progressive experience in contract law and data privacy. The ideal candidate thrives in collaborative settings, working alongside multiple stakeholders to provide comprehensive legal solutions that drive Regeneron's success. The role will be based onsite at our offices in Cambridge, MA or Sleepy Hollow, NY. This is not open to fully remote-based work arrangements. If eligible, we can offer relocation benefits. A typical day might include the following: Providing legal support for a particular area of business transactions, which may include research collaboration agreements, master services agreements, consulting services agreements, license agreements, data use agreements, laboratory services agreements and confidentiality agreements, among others. Maintaining subject matter expertise in data privacy laws and the Regeneron privacy policies and advising Transaction Law colleagues and clients on developments of importance. Providing ongoing one-on-one support to members of the Transaction Law team and coordinating with internal teams and external resources to negotiate and finalize data privacy language in third-party agreements. Responding to U.S. and ex-U.S. contracting questions. Managing updates to group's data privacy contracting playbook. Creating data privacy contracting tools and training materials. Managing office hours with internal business partners. Developing and training on privacy contracting tools and requirements. Acting as liaison for the Transactions Law Group with the Data Privacy Office on data privacy policy questions and approaches. This role might be for you if: You have the ability to work independently, while meeting aggressive deadlines and juggling multiple matters. You are able to maintain an objective perspective while developing and maintaining strong partnerships with key stakeholder / client organizations and protecting Regeneron's interests. You can work effectively and professionally with colleagues and clients at all levels of the organization and in a collaborative, team-oriented environment. You have the ability to effectively convey to, and respond to questions from, colleagues and key stakeholders, on data privacy law concepts. To be considered for this position you must possess a JD with excellent law school credentials. Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel is preferred. At least 7 years of legal experience at a law firm and/or in-house, with some biotech/pharmaceutical and/or health care experience is preferred. Solid understanding of contracts and related law. Experience with contracts involving data privacy and intellectual property. You should also have a high level of business acumen, excellent contract drafting and negotiation proficiency, exceptional oral and written communication skills and interpersonal and conflict resolution capability. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $202,000.00 - $336,600.00
    $202k-336.6k yearly Auto-Apply 60d+ ago
  • Principal IS Business Analyst - Clinical Study Design and Analysis

    Amgen 4.8company rating

    Remote job

    Career CategoryInformation SystemsJob Description 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. Principal IS Business Analyst - Clinical Study Design and Analysis What you will do Let's do this. Let's change the world. Amgen is seeking a Principal IS Business Analyst to join the Clinical Study Design and Analysis (CSDA) product team. You will be responsible for "Run" and "Build" project portfolio execution, collaborate with business partners and other IS service leads to deliver IS capability and roadmap in support of business strategy and goals. The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborates with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Captures the voice of the customer to define business processes and product needs. Works with Product Managers and customers to define scope and value for new developments. Collaborates with Engineering and Product Management to prioritize release scopes and refine the product backlog. Ensures non-functional requirements are included and prioritized in the product and release backlogs. Facilitates the breakdown of epics into features and sprint-sized user stories and participates in backlog reviews with the development team. Clearly expresses features in user stories and requirements so all team members and stakeholders understand how they fit into the product backlog. Translates complex business and technological needs into clear, actionable requirements for development teams. Ensures acceptance criteria and definition of done are well-defined. Works closely with UX to align technical requirements, scenarios, and business process maps with user experience designs. Stays focused on software development to ensure it meets requirements, providing proactive feedback to stakeholders. Develops and executes effective product demonstrations for internal and external stakeholders. Maintains accurate documentation of configurations, processes, and changes. Serves as a liaison between global DTI functional areas and global development scientists, prioritizing their needs and expectations. Manages a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree and 2 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Master's degree and 4 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor's degree and 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Associate's degree and 10 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR High school diploma / GED and 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery through technology. Experience with Agile software development methodologies (Scrum). Excellent communication skills and the ability to interface with senior leadership with confidence and clarity. Experience in writing requirements for the development of modern web applications. Experience in writing user requirements and acceptance criteria in Agile project management systems such as JIRA. Good-to-Have Skills: Demonstrated expertise in a clinical development domain and related technology needs. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code and no-code test automation software. Technical thought leadership. Ability to communicate technical or complex subject matters in business terms. Experience with Jira Align. Knowledge of cloud platforms (AWS, Azure/Databricks, GCP) and enterprise infrastructure technologies. Experience with DevOps, continuous integration, and continuous delivery methodologies. Professional Certifications: SAFe for Teams certification (preferred). Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members, with a demonstrated ability to delegate work effectively. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. 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. . Salary Range 143,358.00 USD - 173,256.00 USD
    $113k-142k yearly est. Auto-Apply 13d ago
  • Principal Human Factors Engineer, Abiomed

    Johnson & Johnson 4.7company rating

    Danvers, MA job

    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: Industrial Design & Human Factors Job Category: Scientific/Technology All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: Johnson & Johnson is hiring for a Principal Human Factors Engineer - Abiomed to join our team located in Danvers, Massachusetts. 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 Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech ABOUT US: Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. Patients First | Innovation | Winning Culture | Heart Recovery POSITION SUMMARY Our Human Factors Engineers and Designers are focused on improving patient outcomes through better usability, rapidly developing next generation products for heart recovery by placing our users at the center of our design process. * We develop solutions that balance the needs of various users; surgeons, physicians, hospital staff, patients and caregivers. * Our team works across all global Abiomed platforms striving for best practice usability and true human centered design. KEY RESPONSIBILITIES: The Principal Human Factors Engineer will: * Influence the HF/Usability strategy and contribute to human factors efforts for programs from concept through post market support, supporting usability activities for all product lines and programs with minimal oversight. * Develop an understanding of intended use environments gained through good understanding of intended user types formed through interactions with users. * Work on problems of diverse scope that impact the broader program team and business and leads projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for creating risk mitigations and associated evaluations. * Mentor other engineers on project, and supervise/direct third party contractors/consultants; including reviews of deliverables to ensure accuracy * Network with key contacts outside own area of expertise, contributes to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development REQUIREMENTS: * University/bachelor's degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, or Equivalent; Post-Graduate Degrees (MS) are a plus. * Minimum of 8 years' work experience in human factors / usability engineering experience or equivalent experience in product development and customer interactions is required. Medical Device product development or experience working in a highly regulated industry is a strong plus. * Demonstrated proficiency with the human factors engineering process (research, planning, risk assessment, and regulatory submissions) and principles (task and use-related risk and root cause analysis methods). * Expertise in planning, executing (including moderation), documenting, and reporting usability testing including consolidating user feedback into concise, meaningful design insights and actionable recommendations. * Basic knowledge of anthropometrics, biomechanics, and physiology is preferred. * Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for improvement * In depth knowledge of FDA, ISO, AAMI, and other relevant usability regulations and standards. Knowledge of the ISO 14971 and IEC 62304 are a plus. * Fluent in English. German is an advantage. * Ability to travel up to 5%, domestic and international is required. Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace. 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 & 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 contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $117,000 - $234,000 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 (401k).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. For additional general information on Company benefits, please go to: - ********************************************* #LI-Onsite Required Skills: Collaborating, Communication, Compliance Management, Innovation, Problem Solving Preferred Skills: Analytical Reasoning, Coaching, Concept Testing, Critical Thinking, Customer Intelligence, Human Factor Engineering, Industry Analysis, Organizing, Product Design, Product Improvements, Product Portfolio Management, Product Strategies, Product Testing, Prototyping, Research and Development, Risk Management, SAP Product Lifecycle Management, Technical Credibility The anticipated base pay range for this position is : US : $117,000.00 - $234,000.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $117k-234k yearly Auto-Apply 57d ago
  • Associate Director, Biostatistics - Hematology

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA job

    This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. In this role, a typical day might include: The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will represent statistical issues in regulatory agency meetings. The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications. As an Associate Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage full-time staff. This role might be for you if can: * Represent Biostatistics at Global Clinical sub-teams. * Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials. * Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc. * Lead and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables. Authors new/revised SOPs and contributes to cross-functional EPIC workstreams. * Evaluate appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools. * Prepare presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management. * Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians. To be considered for this opportunity, you must have the following: * PhD or equivalent degree in statistics/biostatistics with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience * Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar Therapeutic Area. * Time to Event (TTE) experience. * Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies. * Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment. * Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills. * Solid knowledge of statistical analysis methodologies, experimental and clinical trial design * Expertise in statistical software Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $173,500.00 - $283,100.00
    $173.5k-283.1k yearly Auto-Apply 4d ago
  • Director, Medical Affairs Lead - Haematology

    Regeneron Pharmaceuticals 4.9company rating

    Uxbridge, MA job

    Are you ready to make a meaningful impact in the field of haem-oncology? At Regeneron, we are seeking a dedicated Medical Affairs Lead to be the driving force behind our haem-oncology program in multiple myeloma and lymphoma. As a pivotal member of our team, you will serve as the medical contact in-country, collaborating with internal teams and external stakeholders to advance scientific understanding, improve patient care, and ensure the success of our therapeutic strategies. Join us in shaping the future of haem-oncology while working in a dynamic and supportive environment. A Typical Day: * Represent Regeneron as the in-country medical contact for haem-oncology, engaging with medical societies, academic leaders, and thought leaders. * Collaborate with cross-functional teams, including clinical development, regulatory, market access, and commercial colleagues, to optimise strategic and tactical planning. * Manage and develop a high-performing haem-oncology medical team, ensuring compliance, training, coaching, and execution of initiatives. * Provide medical support for clinical development activities, such as identifying key investigators and supporting patient recruitment efforts. * Stay updated on scientific advancements and therapeutic developments in haem-oncology to enhance strategic decision-making. * Participate in scientific engagements and deliver impactful presentations to diverse audiences, including healthcare professionals and stakeholders. * Lead medical education initiatives, ensuring alignment with local needs and compliance with ABPI and IPHA codes. * Collaborate with global teams to prepare for product launches, market access strategies, and life cycle management initiatives. This Role May Be For You If You: * Are a physician (M.D.) or scientist (PhD) with expertise in haem-oncology and experience in Medical Affairs within the pharmaceutical or biotech industry. * Have a strong knowledge of ABPI and IPHA codes, coupled with experience supporting research and clinical development in the UK. * Excel at building relationships with key stakeholders, including thought leaders, and can cultivate trust through scientific expertise and follow-through. * Possess strong leadership skills, inspiring and motivating teams while fostering collaboration and inclusion. * Are proactive, resourceful, and thrive in a fast-paced, innovative environment. * Are skilled at juggling multiple projects, delivering actionable insights, and maintaining attention to detail. * Embody an entrepreneurial attitude and demonstrate a commitment to ethical and scientific standards. * Are fluent in English and willing to travel 30-50% of the time. To Be Considered: Applicants must hold an M.D. or PhD with expertise in haem-oncology and have substantial pharmaceutical or biotech industry experience in Medical Affairs. A thorough understanding of the UK healthcare environment and ABPI/IPHA codes is essential. Preferred candidates will have experience supporting clinical development in haem-oncology, a solid background in life-cycle product development, and a proven ability to work cross-functionally in matrix environments. Strong leadership, communication, and organisational skills are critical for success in this role. Join Regeneron and contribute to advancing haem-oncology care while working with a team of passionate professionals dedicated to innovation and patient outcomes. Apply today to make a difference! Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
    $108k-140k yearly est. Auto-Apply 41d ago
  • United States Regulatory Professional- Obesity and Related Conditions

    Amgen 4.8company rating

    Remote job

    Career CategoryRegulatoryJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. OR United States Regulatory Professional (USRP)- Obesity and Related Conditions TA Live What you will do Let's do this! Let's change the world! Amgen is seeking a United States Regulatory Professional (USRP) supporting products in the Obesity and Related Conditions Therapeutic Area (TA). Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of Amgen molecules. In this product-facing role, you will support the creation and submission of regulatory documents under the supervision of a more experienced regulatory lead. The USRP provides operational support for U.S. regulatory execution by coordinating submission deliverables, maintaining compliant documentation, and partnering cross-functionally to enable effective health authority engagement. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Key responsibilities Coordinate and execute U.S. regulatory submissions in compliance with Amgen corporate standards and FDA requirements. Drive submission readiness by coordinating inputs, tracking timelines, and ensuring deliverables are complete, accurate, and submitted on time. Maintain regulatory documentation and records, including preparation, delivery, and electronic archiving of submission content and agency communications. Create and maintain product regulatory history documentation (e.g., IMR, as applicable). Support U.S. labeling activities, including review of source text to enable U.S. labeling updates. Support review of promotional and non-promotional materials as applicable and in accordance with internal requirements. Coordinate and QC briefing documents and other materials for meetings with regulatory agencies. Under general supervision, support FDA interactions and act as a point of contact as appropriate to fulfill product-specific obligations. Support responses to health authority questions by coordinating inputs, tracking actions, and ensuring document readiness. Collate and communicate regulatory information across regulatory colleagues and cross-functional teams; provide timely updates on U.S.-specific considerations. Maintain awareness of emerging U.S. legislation, guidance, and regulatory policy; escalate and disseminate relevant updates to appropriate stakeholders. Participate in cross-functional and team governance (e.g., GRT support including agendas/minutes) as needed. Basic Qualifications: Master's degree in biology, life science, health science, or regulatory science with a biology curriculum OR Bachelor's degree in a science discipline (biology, life science, health science) and 2 years of directly related experience OR Associate's degree in a science discipline (biology, life science, health science) and 6 years of directly related experience OR High school diploma / GED in a science discipline (biology, life science, health science) and 8 years of directly related experience Preferred Qualifications: Experience in a regulated industry (e.g., biotech/pharma, medical device, clinical research, healthcare) Experience supporting programs in Obesity, Diabetes, or related metabolic diseases through scientific or clinical work Strong written and oral communication skills Strong organizational skills; ability to manage multiple activities, timelines, and stakeholders Demonstrated attention to detail and document quality mindset Ability to identify, communicate, and escalate risks/issues appropriately Experience with document management and archiving practices in a regulated setting Thrive 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. 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. Sponsorship Sponsorship for this role is not guaranteed. 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. . Salary Range 88,347.00 USD - 110,633.00 USD
    $72k-99k yearly est. Auto-Apply 2d ago
  • Principal Mechanical Engineer

    J&J Family of Companies 4.7company rating

    Danvers, MA job

    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 Mechanical Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Danvers, Massachusetts, United States of America **Job Description:** We are searching for the best talent for a Principal Mechanical Engineer. 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 Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech **Key responsibilities** + Lead technically complex design efforts from concept through verification and support through transfer to manufacturing, product launch and sustaining. + Act as the recognized subject matter expert in one or more engineering domains (e.g., precision mechanisms, temporary pump technology, fluid-structure interactions, materials and fabrication). + Translate clinical observations and user needs into validated device concepts and engineering requirements. + Rapidly prototype, test, iterate, and optimize mechanical designs using a variety of fabrication and bench-test techniques. + Perform and lead troubleshooting, incident investigations, and root-cause analysis for design failures or performance issues; develop and implement robust corrective and preventive actions to prevent recurrence. + Provide formal input to and lead aspects of the design review process; conduct project post-mortem (lessons-learned) activities and close the loop on improvement opportunities. + Produce clear, rigorous technical documentation including technical reports, technical memoranda, test plans, test reports, design inputs/outputs, and risk analyses for internal and external audiences. + Present technical findings, project status, and risk trade-offs to R&D management and cross-functional stakeholders. + Mentor, coach, and train junior engineers on engineering methods, tools, manufacturing-feasible design, testing, and problem-solving techniques. + Collaborate effectively with cross-functional teams including Clinical, Regulatory, Quality, Manufacturing, and Suppliers to drive product success. + Promote and apply J&J Credo values and leadership imperatives in decision-making and team objectives. **Required qualifications** + BS in Mechanical Engineering or equivalent. + Minimum 10 years of hands-on product design experience in medical device product development (or equivalent industry experience). + Proven track record delivering medical device projects from concept through verification and launch. + Expert proficiency with 3D CAD (SolidWorks preferred) and geometric dimensioning and tolerancing (GD&T). + Experience in prototyping and fabrication of metal and plastic parts and assemblies. + Strong analytical skills in tolerance stack-up, DFM/DFMEA, FEA or bench-test-driven validation approaches. + Demonstrated experience with root cause analysis tools and methods (8D, 5 Whys, Fishbone, FMEA). + Excellent written and verbal communication skills; demonstrated ability to produce technical reports and present to technical and non-technical audiences. + Experience coaching and mentoring junior engineers. + Ability to work collaboratively in a fast-paced, cross-functional environment. **Preferred qualifications** + Advanced degree or equivalent in Mechanical Engineering or related field. + Experience with cardiovascular/hemodynamic support devices or other implantable/insertable medical technologies. + Familiarity with medical device regulations and design controls (e.g., FDA, ISO 13485) and risk management per ISO 14971. + Test method development and instrumentation experience (flow rigs, pressure instrumentation, high-speed imaging). + Experience supporting transfer to manufacturing and supplier development. **Core competencies** + Technical leadership and independent problem solving. + Systems thinking and ability to balance trade-offs (performance, reliability, manufacturability, cost). + Strong attention to detail and documentation rigor. + Influencing and stakeholder management across functions. + Continuous improvement mindset and commitment to quality and patient safety. **Work environment and physical requirements** - Primarily office and laboratory/bench environment with regular hands-on work at prototyping and test benches. - May require occasional travel to suppliers, contract manufacturers, or clinical sites. 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 & 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 contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $117,000.00 - $201,250.00 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 (401k).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. For additional general information on Company benefits, please go to: - ********************************************* This job posting is anticipated to close on January 20, 2026. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. **Required Skills:** **Preferred Skills:** Bioinformatics, Biological Engineering, Biostatistics, Clinical Trials Operations, Coaching, Communication, Critical Thinking, Global Market, Healthcare Trends, Medical Affairs, Organizing, Product Development, Project Reporting, Research and Development, Researching, Resource Planning, SAP Product Lifecycle Management
    $117k-201.3k yearly 8d ago
  • Technical Documentation Specialist

    J&J Family of Companies 4.7company rating

    Danvers, MA job

    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:** Marketing **Job Sub** **Function:** Advertising & Promotions **Job Category:** Professional **All Job Posting Locations:** Danvers, Massachusetts, United States of America **Job Description:** **We are searching for the best talent for a Technical Documentation Specialist.** 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 Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This person will work closely with the IFU Operations team, Product Managers, and project originators across the enterprise to assist in global company growth by providing documentation that serves our customers and meets local, federal and international regulations and guidance. The Technical Documentation Specialist will prepare instructions for use manuals and other supporting documents that communicate complex and technical information to customers. This position has overall responsibility for producing and maintaining IFUs and ensuring the accuracy and visual quality of layouts, graphics, and copy. This position may also work with Regulatory, Advanced Clinical Training & Support, Product Management, Engineering, Quality, and other functions. **Key components of the position include:** + Adheres to brand and style guides + Creates new IFUs and updates existing IFUs based on drafts and redlines provided by project originators + Creates new graphics as required and stores appropriately in Veeva Vault + Creates translated sections of IFUs based on translated copy provided by certified translation vendor + Checks quality of own work including copy editing for grammar, punctuation, consistency, clarity, and style as defined by the company guidelines, and incorporates feedback from proofreaders + Receives task assignments in Roadmunk tool, dispositioning and updating status to ensure tracking is always up to date + Stores and distributes design files and final documents in accordance with operational processes and procedures + Prepares documents for printing, including reviewing proofs + Drafts and communicates release notes as IFUs are produced or updated + Exercises excellent service standards and maintains high customer satisfaction through resolving problems by explaining the best solution, expediting corrections or adjustments to provide resolution + Develops knowledge of other roles and responsibilities on the team, and provides support and coverage for other team members as needed + Participates in team and project meetings, and contributes to continuous improvement of processes, tools, and workflows as a member of a small but mission-critical team **Qualifications:** + Associate's or Bachelor's degree in graphic design or a related discipline + 1-3 years' experience with graphic design and technical document creation in a regulated product development environment + Demonstrated strong project management skills and multi-tasking capabilities + Strong attention to detail + Ability to clearly communicate ideas and information (oral and written) and work collaboratively. + Ability to adopt new tools and technologies + Adobe InDesign experience 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 & 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 contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is 79,000 to 127,650. 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 (401k).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. For additional general information on Company benefits, please go to: - ********************************************* This job posting is anticipated to close on January 11, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. **Required Skills:** **Preferred Skills:** Advertising, Analytical Reasoning, Brand Identity, Brand Positioning Strategy, Brand Recognition, Business Behavior, Communication, Content Marketing, Customer Intelligence, Data Analysis, Data Reporting, Design Mindset, Execution Focus, Financial Analysis, Integrated Media Planning, Leverages Information, Marketing Campaign Management, Organizing, Problem Solving, Researching, Sales Promotions
    $64k-88k yearly est. 41d ago
  • Director, External Innovation, R&D Data Science

    Johnson & Johnson 4.7company rating

    Cambridge, MA job

    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: Project/Program Management Group Job Sub Function: R&D Project Management Job Category: Professional All Job Posting Locations: Cambridge, Massachusetts, United States of America Job Description: 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 Director, External Innovation, R&D Data Science, External Innovation will drive the identification, assessment, and execution of strategic AI/ML partnerships that deliver measurable impact across Johnson & Johnson Innovative Medicine (JJIM) R&D. This role is accountable for leading the development of partnerships: producing high-quality diligences, landscape analyses, and partnership assessments that inform and enable decision-making across the R&D value chain, focusing on technologies that apply cutting-edge, multimodal AI/ML to extract insights from generative and agentic AI and complex biological datasets-including genomics, proteomics, transcriptomics, imaging, scientific literature, and emerging data modalities. The role requires deep "bilingual" capabilities across computational and scientific topics, and well as excellent strategic, operational, and communication skills. This position will be based in J&J's Innovation Center in Cambridge, Massachusetts. Summary * Landscape and assess: Conduct rigorous landscaping of external AI/ML capabilities, producing structured assessments that map strategic relevance to JJIM R&D priorities, delivering fit-for purpose landscape reports and assessments * Diligence and partnership development: Lead and participate in end-to-end diligence processes-including scientific scoping, technical evaluation, and business analysis-to support partnership formation with high-impact external entities, delivering detailed diligence briefs and advancing and leading the development of strategic partnerships with transformative potential * Partnership management and oversight: Manage, monitor, and evaluate ongoing strategic partnerships, ensuring delivery against research objectives and business milestones * Strategic contribution: Contribute to JJIM's AI/ML strategy by synthesizing insights from external engagement into actionable recommendations. Actively collaborate with External Scientific Innovation as a member of one of J&J's regional Innovation Centers. Responsibilities: * Deliver comprehensive landscape reports and structured assessments of external AI/ML capabilities (including generative AI) relevant to JJIM R&D priorities. * Lead end-to-end diligence processes-scientific scoping, technical evaluation, and business analysis-to support partnership formation with high-impact external entities. Produce detailed diligence briefs and advance strategic partnerships in collaboration with SMEs, transaction teams, and other stakeholders. * Alliance manage and oversee execution of ongoing strategic partnerships, ensuring delivery against research objectives and business milestones. Provide direction, monitor progress, and generate periodic evaluation reports. * Contribute to JJIM's AI/ML strategy by synthesizing insights from external engagement into actionable recommendations. Collaborate with External Scientific Innovation team at regional Innovation Center Requirements * PhD preferably in Computer science, AI/ML, Statistics, biomedical engingeering, Machine Learning & Artificial Intelligence, Physics, Mathematics, Bioinformatics, Computational Biology, Biology or a related discipline * 8yrs + in related work experience * Proven track record in developing and scaling AI/ML solutions, especially generative models, in a start-up, industrial, enterprise setting * Strong foundation in computer science, with hands-on experience in model architecture, deployment, and performance optimization. * Exceptional strategic thinking, communication, and stakeholder management skills. * Experience working across scientific and technical domains, with the ability to translate complex technical concepts into actionable business strategies. * Experience developing strategic partnerships * Experience in healthcare and/or life sciences * Deep knowledge and expertise in the use of AI/ML for research and discovery within a pharma * Exceptional strategic thinking, communication, and stakeholder management skills. * Experience working across scientific and technical domains, with the ability to translate complex technical concepts into actionable business strategies. * Experience developing strategic partnerships 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 & 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, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-GR #LI-Hybrid #JRDDS #JNJDataScience #JRD Required Skills: Preferred Skills: Agility Jumps, Business Alignment, Continuous Improvement, Mentorship, Performance Measurement, Process Control, Program Management, Project Management Methodology (PMM), Project Management Office (PMO), Project Reporting, Project Schedule, Quality Control (QC), Research and Development, Risk Management, Tactical Planning, Technical Credibility The anticipated base pay range for this position is : $164,000 - $282,900 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $164k-282.9k yearly Auto-Apply 33d ago
  • Sr Electronics Production Engineer

    J&J Family of Companies 4.7company rating

    Danvers, MA job

    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:** Supply Chain Engineering **Job Sub** **Function:** Manufacturing Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Danvers, Massachusetts, United States of America **Job Description:** **About Cardiovascular** 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 Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech **We are searching for the best talent for Sr. Electronics Production Engineer** **Purpose:** This role will drive the scale-up and production of a complex electro-mechanical medical device used in life-saving cardiac support therapies. This role will own scale-up activities, validations, root-cause investigations, safety and regulatory compliance, and continuous process improvement with a focus on cost savings and robust, repeatable manufacturing processes. **You will be responsible for:** + **Scale-Up & Design Transfer** + Lead scale-up from pilot to full-scale production, including process development, equipment qualification, line layout, and work instructions. + Collaborate with R&D and Quality to ensure smooth design transfers and robust manufacturing readiness. + **Validation & Verification** + Plan and execute IQ/OQ/PQ activities for equipment, processes, and software where applicable. + Develop and approve validation protocols and reports; ensure traceability to user needs and regulatory requirements. + **Root Cause Investigation & CAPA** + Lead root-cause analysis for yield loss, quality escapes, and process deviations using structured problem-solving methods. + Implement corrective and preventive actions (CAPA), verify effectiveness, and close with data-driven evidence. + **Safety & Regulatory Compliance** + Ensure manufacturing activities comply with EHS standards and device safety requirements. + Maintain alignment with regulatory expectations (e.g., FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as needed. + **Process Improvement & Cost Savings** + Identify and execute Lean/Six Sigma projects to improve throughput, reduce cycle times, increase yield, and lower cost per unit. + Apply statistical methods (DOE, SPC, MSA, Cp/Cpk analysis) to optimize processes and sustain gains. + **Quality Systems & Documentation** + Maintain and improve documentation: SOPs, work instructions, MBR/Device History Records, change controls, and validation artifacts. + Develop and manage PFMEA, Control Plans, and ongoing quality checks to ensure product reliability. + **Production Support** + Provide hands-on troubleshooting on the manufacturing floor; drive standard work, line balancing, and equipment optimization. + Monitor key production metrics and implement actions to meet targets for quality, cost, and schedule. + **Cross-Functional Collaboration** + Partner with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to align on program milestones, risk, and resource needs. + Mentor and coach junior engineers and technicians; contribute to a culture of continuous improvement. **Qualifications / Requirements:** + Bachelor's degree in Engineering (Electrical, Mechanical, Biomedical, Industrial, or related). Master's degree strongly preferred. + 6-10+ years of manufacturing engineering experience in electronics or medical devices (device hardware, electronics assembly, or related fields). + Working knowledge of FDA QSR/21 CFR Part 820 and ISO 13485. Experience supporting or leading design transfers, validation activities, and quality systems in a regulated environment. + Proficient in DOE/DOE-based experiments, statistical process control (SPC), capability analyses (Cp/Cpk), MSA, and root-cause analysis methodologies. + Experience with process validation (IQ/OQ/PQ) and risk-based approaches to manufacturing. + Familiarity with PCB/SMT assembly, soldering, testing, electronics packaging, and related manufacturing processes. + Experience with change control, CAPA, PFMEA, control plans, and documentation management. + Excellent problem-solving, communication, and project-management skills. + Ability to work cross-functionally, influence without authority, and manage multiple priorities in a fast-paced environment. 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 & 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, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. \#LIOnsite **Required Skills:** **Preferred Skills:** Accelerating, Coaching, Critical Thinking, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Performance Measurement, Product Design, Program Management, Project Engineering, Project Schedule, Risk Compliance, Robotic Automation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy **The anticipated base pay range for this position is :** $94,000.00 - $151,800.00 Additional Description for Pay Transparency: $91,000 - $147,200 This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year Please use the following language: For additional general information on Company benefits, please go to: - *********************************************
    $94k-151.8k yearly 41d ago

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Moderna may also be known as or be related to MODERNA, INC., ModeRNA Therapeutics (2010–2018) and Moderna.