- Merck & Co. (Upper Gwynedd, PA)
- …Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance , Regulatory ... regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Merck & Co. (Rahway, NJ)
- …Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management, Regulatory Affairs Compliance {+ 4 more}-Preferred ... model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs ,...health authorities.- Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements,… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director, Policy. Other internal relationships include a dotted ... line with Corporate Tax, as well as other Market Access & Public Affairs teams, Medical, Legal, Compliance , Communications and other key stakeholders locally and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(Pricing, Contracting, Operations and Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs , and Legal & Compliance . External relationships include ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Eisai, Inc (Nutley, NJ)
- …and provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (North Wales, PA)
- …resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research, and will support Pneumococcal Vaccines.Under the ... guidance of a senior leader, this position supports value evidence outcomes research...is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership Team (LT). ... supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the...and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops… more
- Merck & Co. (North Wales, PA)
- …with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior -level and first-line ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Insights, Supply Chain, Procurement, Public Affairs , Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance . External ... Works closely with Enterprise Insights, Finance, Market Access, Legal, and Compliance to establish and monitor the program operations and related forecasts… more
- Merck & Co. (North Wales, PA)
- …Product Development Teams, Franchise Teams, Regional Product Directors, affiliates, Public Affairs , and Medical Education to ensure value evidence programs are ... strategies and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement… more
- Pivotal Solutions (Boston, MA)
- …with company objectives. Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs , and Marketing, to ensure cohesive medical ... Job Description Position Overview: The Sr . Director of Medical Affairs plays...ensure the safety of products. Ensure that all Medical Affairs activities comply with regulatory and industry… more
- Arkema (Broomall, PA)
- …to assure compliance with legal and corporate product stewardship and regulatory affairs requirements in a cost effective and efficient manner. This ... Hazard Communication, Hazardous Materials Transportation and HTSUS product classifications), product regulatory affairs , and product risk management as such… more
- Fotona (Irving, TX)
- …with evolving regulatory landscapes. Ideal Profile: 7+ years of experience in regulatory affairs , legal compliance , or risk management, ideally within ... role responsible for shaping Fotona's compliance infrastructure, partnering with senior stakeholders, and ensuring sustained regulatory excellence across our… more
- Cleerly (Denver, CO)
- …regulatory compliance issues. Mentorship & Development: Mentor and develop senior regulatory professionals, guiding them through complex regulatory ... in the job description. About the Opportunity As Principal Regulatory Affairs Specialist, you will provide ... regulatory submission pathways and approval options. Global Regulatory Compliance : Ensure medical devices meet … more
- BioTalent (Carlsbad, CA)
- …medical device company in beautiful North San Diego! We're seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory ... inspections. Qualifications: Bachelor's degree with a minimum of 5 years of Regulatory Affairs experience in the medical device industry. Hands-on experience… more
- EPM Scientific (San Diego, CA)
- Title: Senior Specialist/Manager of Regulatory Affairs Summary: A global leader in medical technology is seeking an experienced and driven Regulatory ... If you have strong communication and problem-solving skills and are passionate about regulatory affairs in the medical device industry, this could be the… more
- CryoLife (Kennesaw, GA)
- …information about Artivion, visit our website, www.artivion.com. Position Overview: The Regulatory Affairs (RA) Specialist is responsible for supporting ... Responsibilities: Support manufacturing site needs to meet local objectives and maintain regulatory compliance . Provides support for product regulatory … more
