- Careerbuilder-US (Princeton, NJ)
- …into narrative text. Liaises with internal groups, ie, Biostatistics, Data Management, Regulatory Affairs , Medical Affairs , Clinical Development, Clinical ... person for production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- Tris Pharma (Monmouth Junction, NJ)
- …oversight of clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs , Product Development, Research and Development ... (R&D), Quality Assurance (QA), Pharmacovigilance, Medical Affairs , etc.) on strategic and tactical clinical development issues...trial data and translates data into actionable plans at product levelContributes to Medical aspects of Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned ... and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to...Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... grow and expand. Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The ...through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The… more
- Abbott (Princeton, NJ)
- …submission to US FDA. + Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions. + ... in the Abbott Point of Care Division. As a ** Regulatory Affairs Manager** , your role involves...develop and manage regulatory professionals. + Provide regulatory input to product lifecycle planning. +… more
- dsm-firmenich (Princeton, NJ)
- Regulatory Affairs Manager/Personal Care Princeton, NJ, US Hybrid Are you passionate about the cosmetic and OTC sunscreen regulations in North America with a ... centric mindset? Join us in our journey! As a Regulatory Affairs Manager North America (NA), you...and personal care specialty chemicals products are evaluated for safety and regulatory conformance + Support the… more
- Bausch Health (Bridgewater, NJ)
- …business acumen and the ability to see business drivers outside of regulatory affairs + Working knowledge of the Rx product NDA and labeling processes + ... and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and… more
- Ascendis Pharma (Princeton, NJ)
- …global strategies and local regulations . Coordinate US labeling activities for regulatory submissions, product maintenance and safety variations, including ... a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- US Tech Solutions (Titusville, NJ)
- …including: + Partnership across Medical Affairs , RW V&E, JRD, Brand Marketing, Regulatory Affairs , Global Medical Affairs , New Business Development, J&J ... work force. Adherence to project budgets and timelines, the safety and privacy of research participants, and compliance with...Doctorate, PhD, or PharmD + Will be monitoring trials, regulatory affairs , etc with competition + Will… more
- Bristol Myers Squibb (Princeton, NJ)
- …Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and ... Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and… more
- Bristol Myers Squibb (Princeton, NJ)
- …Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings ... activities and benefit-risk strategies for assigned BMS compounds/ program and chair the product Safety Management Team(s). + Oversee aggregate safety review… more
- Terumo Medical Corporation (Somerset, NJ)
- …to management on pricing, manufacturing, packaging, distribution, promotion, market research, regulatory , legal and any issue which impacts product ... initial installation and maintenance of products. + Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality… more
- Terumo Medical Corporation (Somerset, NJ)
- …& Safety and Quality System policies, programs, rules and practices, taking account product and patient safety , the health and safety of all associates ... NJ, US, 08873 Company: Terumo Medical Corporation Department: Medical Affairs Operations Terumo Medical Corporation (TMC) develops, manufactures, and markets… more
- Terumo Medical Corporation (Somerset, NJ)
- …this position may assist with directing changes in company policy to ensure product safety , product effectiveness, ethical behavior &/or compliance with ... product recall from the market, to litigation, &/or regulatory action by the FDA to address the situation....CIOs, Directors, Management staff & associates in HR, Quality, Regulatory Affairs , Clinical Affairs , Facilities… more
- Sanofi Group (Bridgewater, NJ)
- …Collaborate with colleagues in Medical Affairs , Commercial, Research and Development, Drug Safety , Sales & Marketing and Regulatory to ensure success of the ... review and approval of medical and scientific content of Regulatory , Safety , Scientific Affairs , Medical...across brands (where possible) measurable policies regarding customer and product medical education within the team to assure a… more
