- 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)
- …to internal and external stakeholders. Relationships This position will report to Senior Director or Executive Director Safety Surveillance, US East Coast ... Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... information to internal and external stakeholders. Relationships This position will report to Executive Director - Safety Surveillance, US East Coast Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned...external stakeholders. Relationships This position will report to Executive Director of Global Safety US East Coast… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational work for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs , Patient Safety required A thorough ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Analytics team members, Global commercial and New Product Planning teams, Medical Affairs , Regulatory Affairs , Legal, and Market Access. Collaborates ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Insmed Incorporated (San Diego, CA)
- …team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality, and ... expertise to internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory Affairs , R&D, and Legal) and external (healthcare… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and Operational… more
- Merck & Co. (Rahway, NJ)
- …of interest.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, Enterprise Insights, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, Enterprise Insights, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May… more
- AbbVie (North Chicago, IL)
- …objectives, both strategic and applicable regulatory requirements. Director , Safety , Regulatory and Medical Affairs Quality Standards is responsible ... for the management of a RDQA global Safety , Regulatory Affairs (RA) and...role reports to the Senior Director of Safety , Vigilance and Medical Affairs Quality Assurance.… more
- Herbalife (Torrance, CA)
- Director , Global Regulatory Affairs -...**Overview** **THE ROLE:** Reporting to the VP of Global Regulatory & Post-market Safety Affairs , this ... implementation of strategy for multiple complex projects led by the corporate regulatory affairs team, including process improvement for efficiency gain,… more
- Gilead Sciences, Inc. (Foster City, CA)
- … affairs organization. The incumbent will collaborate with patient safety , quality, regulatory CMC, commercial, clinical, and other development organizations ... help create possible, together. **Job Description** The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and… more
- Lilly (Indianapolis, IN)
- …from an accredited college or university + At least 5 years of regulatory affairs experience with research-based drug development, including early phase (first ... to evolve how Lilly and LRL operates. The **Senior Director ** is responsible for managing all Regulatory ...experience. + Demonstrated understanding of clinical drug development and regulatory affairs , including regulations in the US,… more
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of Quality ... the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading, and executing large scale… more
- Inovio Pharmaceuticals (Plymouth Meeting, PA)
- …disease-fighting tools. For more information, visit www.inovio.com . Job summary The Senior Director , Regulatory Affairs , Combination Products will have a ... position may have direct and/or indirect personnel management responsibilities. The Senior Director , Regulatory Affairs , Combination Products will ensure… more
