- Merck & Co. (Rahway, NJ)
- …subject matter expert in flow cytometry, working with project teams, biomarker leaders, clinical operations, regulatory affairs , and physicians to implement ... Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Genmab (Plainsboro, NJ)
- …the US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross ... regional strategies and tactics with appropriate use of resources.Work with clinical development, regulatory , commercial, and market access teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role will interface with key stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial ... About the Department The Clinical , Medical and Regulatory (CMR) department...and Global HQ. Key internal relationships include Project Managers, Clinical Directors, Medical Affairs directors, HEOR Directors,… more
- Insmed Incorporated (San Diego, CA)
- …and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical ... and Risk-Evaluation and Mitigation Strategies (REMS). Ensures, in collaboration with Regulatory Affairs labeling team, an accurate representation and… more
- Tris Pharma (Monmouth Junction, NJ)
- …statistical guidance and support to cross-functional teams including, but limited to: Clinical Development, Regulatory Affairs and Medical WritingManages and ... managers and other stakeholders to ensure data quality and compliance with regulatory requirementsContributes to preparation of clinical study reports, … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. External ... 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
- Aequor (Bothell, WA)
- Job Title: Regulatory Affairs Contractor Work Location: Bothell, WA 98021 - Hybrid role - 3 days onsite , 2 days remote - locals only Duration: 12 months ... Bridge (Camera-On) Request-ID#33378-1 Job Description: POSITION SUMMARY: Team is seeking a Regulatory Affairs Contractor to contribute to the development and… more
- Merck & Co. (Rahway, NJ)
- …spectrometry-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the ... Molecular Biomarkers (TMB) is responsible for the development and execution of clinical biomarker assays across all therapeutic areas and all phases of … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... About the Department The Clinical , Medical and Regulatory (CMR) department...Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional… more
- Genmab (Plainsboro, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be ... of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs , the key responsibilities… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …relating to compliance efficiently and with utmost professionalism. The Director of Regulatory Affairs will also interact with many consultants, Exela's contract ... compiling, publishing and submission of regulatory dossiers. The Director of Regulatory Affairs will participate in discussions on change controls, quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical , Medical and Regulatory (CMR) department...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Merck & Co. (North Wales, PA)
- …via coordination with the field medical leadership team, Headquarters (HQ) Medical Affairs teams, Global Clinical Development, and IIS teamsAssists Country ... collaborates with leadership within Country Field Medical, Research & Development (R&D) Clinical Development, Global Center for Scientific Affairs (GCSA), and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders across CDSE and more broadly within Clinical , Medical and Regulatory , Market Access and Public Affairs . Externally, this individual is ... with cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory ,...of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to facilitate the… more
- Formation Bio (New York, NY)
- …and preventive actions (CAPA as needed. Collaborate with cross-functional teams (eg, CMC, Regulatory Affairs , Clinical Operations) to ensure alignment on ... and perform batch record reviews to ensure accuracy, completeness, and compliance with regulatory requirements. Manage QA release of clinical trial materials to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborations within and across line functions, eg Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Operations. Formulates ... with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge.This position independently addresses… more
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