- 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
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Director , Global Regulatory Labeling is responsible for overseeing the prioritization, ... creation, review, approval, and maintenance of finished goods labeling artwork and templates. This role requires a solid...templates. This role requires a solid understanding of global labeling requirements, a basic understanding of labeling … 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare 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
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can be located in Spring House, PA; Horsham, PA; ... potential. At Johnson & Johnson, we all belong. The Director , Global Regulatory Leader, is responsible for global regulatory...Regulatory Team (GRT): + Serve as a member of Labeling Working Group (LWG) to build or update the… more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Director , Patient Centered Outcomes Research, is responsible for the design and execution of ... of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible PED champion and subject matter expert within… 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
- Ascendis Pharma (Princeton, NJ)
- Medical Director Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are ... the Endocrine Medical Sciences team for the US business, the Medical Director handles deliverables and activities associated with management and implementation of… more
- Novo Nordisk (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions + Provide… 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
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global ... proceedings to support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for developing and maintaining… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …(including Reference Safety Information) and Investigator Brochure, as well as other labeling documents. + Demonstrate knowledge of local and global health authority ... requirements. + Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations. + Train and mentor Pharmacovigilance Physicians and Specialists. + Maintain professional knowledge and accreditation… more
- Bristol Myers Squibb (Princeton, NJ)
- …guidelines. The role works closely with the Proofreading team, Labeling Operations, Commercial Regulatory Affairs, and Worldwide Commercialization Excellence (WCE) ... responsible for the seamless implementation of prescribing information and all derivative labeling documents across all brands. This is an important role within US… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …schedules and coordinates daily priorities for incoming raw materials and labeling components, in-process testing, finished product sampling, in-process labeling ... incoming raw material, in-process material, finished product and in-process packaging/ labeling operations sampling and inspection activities. + Trains, supervises… more
- Bristol Myers Squibb (Princeton, NJ)
- …Channel Operations is responsible for managing the operational processes associated with product labeling updates in the US market. This role will define, drive, and ... managers). The team will be responsible for the seamless implementation of updated labeling across all active brands. This is an important role within US… more
- Ascendis Pharma (Princeton, NJ)
- …As part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs, Advertising and Promotion. There is a preference for this position ... the commercial regulatory impact of new campaign concepts, target, or product labeling , and to provide strategic regulatory guidance on corporate communications and… more
- Hunterdon Health Care System (Flemington, NJ)
- …for the Department of Pharmaceutical Services. They are responsible for labeling , preparing, dispensing, and distributing of pharmaceutical products for all patient ... and visitors Reporting Relationships Reports to (position): Pharmacists; Assistant Director of Pharmaceutical Services; Director of Pharmaceutical Services… more
- Integra LifeSciences (Princeton, NJ)
- …outcomes and set new standards of care. Under direct supervision of a Director , Global Marketing - Codman Specialty Surgical, CSS, this role will identify and ... and/or line trimming, forecasting, pricing strategies, literature/video/sales support materials, labeling revisions, clinical studies, manufacturing and customer service/operations support… more