- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- Ascendis Pharma (Princeton, NJ)
- …promotional assets for assigned product(s), and collaborate with Commercial, Legal, and Regulatory for development and review of Labeling , advertising, and ... Regulatory , Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to support… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … issues related to development compounds or marketed products including labeling discussions/updates, interactions with Regulatory Agencies, and Annual NDA ... guidelines. Organizational Relationship/Scope: + This position reports to the Head of Global Medical Affairs. The Senior Medical Director will interact with… more
- Organon & Co. (Jersey City, NJ)
- …2.7.2 and contribute to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Organon & Co. (Jersey City, NJ)
- …, Biopharmaceutics will be the primary author for module 2.7.1 for global regulatory submissions. **Responsibilities** + Provide support for the Biopharmaceutics ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of… more
- J&J Family of Companies (Titusville, NJ)
- …clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are ... matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality… more
- Taiho Oncology (Princeton, NJ)
- …guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are ... Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer… more
- Merck (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling , Regulatory ... Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production… more
- Coty (Morris Plains, NJ)
- … global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is based in ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR MANAGER, US...retailers. + Provide guidance to Product Development regarding OTC labeling and claims. Including working with the global… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. Tanabe Pharma Corporation has discovered and produced several ... development, distribution, importation, export, and vendor management in cooperation with Director of Commercial Supply Chain. This incumbent will drive supply chain… more