- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... leading the development and maintenance of global labeling documents (eg, Core Data Sheet,...Regulatory Affairs (GRA) and will report to the Sr Director , Labeling , Policy and Intelligence. The position… more
- Genmab (Plainsboro, NJ)
- … Global Regulatory Lead, plan, prepare and lead FDA meetings as relevant. Support global regulatory lead and labeling strategy lead in development of the ... authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a… more
- Genmab (Plainsboro, NJ)
- …time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities include but are ... for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science and Global Evidence and Pricing Access. In addition, the Director will represent Novo Nordisk externally and assume a leadership role in collaborations ... 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… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key ... to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content....approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing… 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 ... Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior… more
- Merck (West Point, PA)
- **Job Description** The Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division, is accountable for managing the 'end-to-end' ... Collaborations (~200+). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical...as such, will actively participate in adapting the GCS strategy and priorities to ensure GCS is able to… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …well as other labeling documents. + Demonstrate knowledge of local and global health authority requirements. + Support GPSE in the maintenance of a highly ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Merck (West Point, PA)
- **Job Description** The Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division, is accountable for managing the 'end-to-end' ... Collaborations (~200+). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical...as such, will actively participate in adapting the GCS strategy and priorities to ensure GCS is able to… more
- Sumitomo Pharma (Trenton, NJ)
- …and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in ... regulatory activities for assigned project(s) in line with the global registration strategy of the product +...support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for… more
- CSL Behring (King Of Prussia, PA)
- …lead scientific and clinical expert in the assigned TA(s). Provide input on labeling and regulatory strategy . Maintain in-depth understanding of disease states, ... a true expert in the responsible TA, the Executive Director , will lead the development and execution of Medical...products. Provide key strategic input to shape the portfolio strategy and global clinical development and risk… more
- Ascendis Pharma (Princeton, NJ)
- Medical Director Do you want to be part of...and implementation of the product medical and medical launch strategy as well as work intricately within the other ... the Endocrine Medical Sciences team for the US business, the Medical Director handles deliverables and activities associated with management and implementation of… more
- Merck (West Point, PA)
- **Job Description** The Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... Research Laboratories portfolio of clinical trials. Global Clinical Supply is accountable for the... Clinical Supply is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... that are at regulatory filing stage to develop content strategy for global dossiers. + Ensure consistent...HA deadlines. + Contribute in the developing of target labeling . **Degree / Experience Requirements** + Bachelor's degree required;… 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
