- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...cross-functional impact, including drug device/combination products and software as medical device platforms.- Reviews and resolves issues that span… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory responsibility for field based ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution ... of Global Medical Affairs /MSL training and continued education plans...credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Merck & Co. (Rahway, NJ)
- …Trial Support, Cross-Functional Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, ... efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical… more
- Novo Nordisk Inc. (WA)
- …line with Corporate Tax, as well as other Market Access & Public Affairs teams, Medical , Legal, Compliance, Communications and other key stakeholders locally ... and gathering insights from other departments (Corporate Tax, MA, Comm'l BUs, Medical , Regulatory , Legal, etc) Assigned policy areas may include, but… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs , finance, NNGlobal, and other ... also eligible to participate in Company employee benefit programs including medical , dental and vision coverage; life insurance; disability insurance; 401(k) savings… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality,… more
- Pivotal Solutions (Boston, MA)
- …Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs , and Marketing, to ensure cohesive medical strategies. Scientific ... pharmacovigilance team to ensure the safety of products. Ensure that all Medical Affairs activities comply with regulatory and industry standards. Team… more
- Eisai, Inc (Nutley, NJ)
- …execution of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These ... be used in external interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or MS. Role OverviewAs part ... of the US Medical Affairs team, the Senior ...hired MSLs.Fully understand and apply MSL SOP's/guidelines and company HCC/ Regulatory /Legal guidelines.Requirements2-3 years relevant MSL work experience in therapeutic… more
- Merck & Co. (North Wales, PA)
- …The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates ... national immunization technical advisory groups.Responsibilities and Primary ActivitiesPartners with Medical Affairs counterparts to develop, execute and deliver… 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). ... knowledge management tools and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops to ensure manufacturing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with cross-functional teams, including Field Sales, Marketing, Strategic Partnership and Engagement, Medical Affairs , Market Access and Public Affairs ... (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs , Compliance and other relevant NNI departments to ensure… more
- Leica Biosystems (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work… more
- Merck & Co. (Upper Gwynedd, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …PCOR (Pricing, Contracting, Operations and Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs , and Legal & Compliance. External relationships ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
