- J&J Family of Companies (Titusville, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... Director , RA Labeling Product Leader (1 of 2) in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the ... development and implementation of labeling content and strategy of multiple assigned products in...you will contribute:** With guidance from leadership: Management of Labeling Cross-Functional Teams + Independently leads Labeling … more
- Ascendis Pharma (Princeton, NJ)
- …for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across ... the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with US regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area Description** ... Develop strategy for signal evaluation and document outcome. . Lead safety labeling activities for assigned products/program. Act as the Safety Subject Matter Expert… more
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors ... prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** + Provides… more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a ... Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the… more
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) -...OUS markets. + Serve as a member of the Labeling Working Group to create or update the CCDS and ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located...they are doing in early/late development and knowledge of labeling aspects + Impact and Influence: Able to persuade,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a Director to join our Precision Medicine team. The Director , Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely ... with Senior Director , Precision Medicine CDx and key cross-functional collaborators to...interactions and filings related to Precision Medicine, including product labeling and participates as appropriate in internal and external… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... to Health Authority) + Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDL +… more
- J&J Family of Companies (Trenton, NJ)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical Writing. The ... can reach their potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a highly experienced medical writer and… more
- Taiho Oncology (Princeton, NJ)
- Sr. Director , PV Medical Surveillance Princeton, NJ, USA Req #378 Monday, July 15, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... Proposition: Embark on a transformative journey with Taiho Oncology as a Sr. Director , PV Medical Surveillance . At the forefront of pharmacovigilance innovation, we… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Signal Detection Scientist - 2406212640W **Description** Johnson and Johnson is currently seeking an **Associate Director , Signal Detection ... event data reviews, evaluations of drug safety issues, adverse event dictionaries, core labeling , and Periodic Safety Review preparation * Ability to lead projects *… more
- J&J Family of Companies (Titusville, NJ)
- Director , Medical Safety Officer (Neurovascular) - 2406209070W **Description** **Johnson & Johnson, is recruiting for a Director , Medical Safety Officer ... categorization of product/product families. Review and provide input on: mitigations, labeling and internal and customer safety training materials directed to… more
- Cardinal Health (Trenton, NJ)
- …scheduling patient doses. Doses we manufacture are delivered when you need them. The Director , Quality Management - PET will be responsible for leading a team of 8 ... procedures related to quality, facilities and equipment, materials, production, packaging, labeling and laboratory control systems. Provide controls to ensure proper… more
- Sanofi Group (Bridgewater, NJ)
- …you thought was possible. Ready to get started? The Clinical Research Director (CRD), Dupilumab, Immunology and Inflammation Therapeutic Area is responsible for the ... participates to the review process for protocols, study reports, labeling , and contributes/supports interactions with regulatory agencies and ethics committees.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …renewals, responses to Health Authority) - Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration ... with the CDL - Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives - May lead the development and updates of the Investigator's Brochure (IB):… more
- Bristol Myers Squibb (Princeton, NJ)
- …with HA deadlines. + Contribute in the developing of target labeling . **Degree / Experience Requirements** + Bachelor's degree required; advanced scientific ... degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ability to broadly represent the… more
- Bristol Myers Squibb (Princeton, NJ)
- …or GRL as needed + Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes in the global/US regulatory ... environment and provide strategic guidance regarding development plans as a result. + Foster positive relationships with FDA. + Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion &… more