- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling , Policy and Intelligence. The position will be based in our Princeton, New… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …and immune disorders. SummaryThis 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. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- …and External Collaborations (~200+). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across ... more than 60+ countries, all in accordance with US and WW regulations, company policies and standard operating procedures.The head of GCS External Partnership & Sourcing is a core member of GCS LT and as such, will actively participate in adapting the GCS… more
- Merck & Co. (Rahway, NJ)
- …and External Collaborations (~200+). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across ... more than 60+ countries, all in accordance with US and WW regulations, company policies and standard operating procedures. Without Clinical supplies, there is no study.The head of GCS Logistics and Regions is a core member of GCS LT and as such, will actively… more
- Merck & Co. (Rahway, NJ)
- …clinical trials.- Global Clinical Supply is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. ... Development Teams.- Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... success. Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and...FDA meetings as relevant. Support global regulatory lead and labeling strategy lead in development of the Company Core… more
- Novo Nordisk Inc. (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
- Genmab (Plainsboro, NJ)
- …programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for the assigned projects Lead ... plans) and ensure that they are implemented, if applicable Collaborate with the Labeling Team Lead to develop Company Core Data Sheet and US Prescribing Information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice ... and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions Provide strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in ... collaboration with the CDLContributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure… more
- Genmab (Plainsboro, NJ)
- …will join a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the Global Clinical Drug Supply ... a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, Denmark.Main Responsibilities IncludeEngage with… 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)
- …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
- Compass Group, North America (New York, NY)
- …but the start of a career where you can flourish. Job Summary The Director of Quality Assurance will lead the development and execution of comprehensive QA programs ... requirements. + Oversee the Allergen Preventive Controls Program, ensuring accurate allergen labeling and prevention of cross-contact in line with Kirkland & Ellis… 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
