- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical ... from Global Safety Surveillance and other cross functional teams. Oversees daily operations of the function by directing staff and adhering to company-wide policies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to guide the successful completion of promotional initiatives. Relationships Reports to Director , Marketing Operations . Primary interaction is with teams that ... Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 position may serve as an...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to collaborate with, and support the head of Global QA strategy and operations . In this position, the incumbent will take on organizational responsibilities relevant ... tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA,...to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... functional teams and various departments to include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain Technical Operations , Pharmaceutical Technology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure ... successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of...of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global ... Strategy and Operations . In collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations ,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make ... and expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where you will utilize your knowledge and… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …true to the best of my knowledge. **Job Description** **About the role:** ** Associate Director , Nonclinical Regulatory Writing and Submission Support,** ... vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory...team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations , Drug Discovery… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 position may serve as an...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to collaborate with, and support the head of Global QA strategy and operations . In this position, the incumbent will take on organizational responsibilities relevant ... tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA,...individuals are current and up to date - Support regulatory inspection related activities as required - Support Head,… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Summary:** This position is accountable for ensuring compliant and efficient operations of the Customer Operations team responsible for the creation ... the following key business partners:Government Price Reporting, Government Contracts Operations , Institutional Contract Administration, Chargeback Operations , Order… more
- Sumitomo Pharma (Trenton, NJ)
- …, Strategic Sourcing - R&D and Supply Chain/TOQ.** The Associate Director Strategic Sourcing R&D and Supply Chain/Technical Operations & Quality (TOQ) ... a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada...policy setting to enable productivity and efficiency improvements. The Associate Director , Strategic Sourcing R&D and Supply… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...such as clinical operations , data management, Pharmacovigilance Operations , Medical Writing and Regulatory Affairs is… 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 at Global Regulatory Team (GRT) + Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead and Labeling Compliance to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... functional teams and various departments to include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain Technical Operations , Pharmaceutical Technology… more
- Bristol Myers Squibb (Princeton, NJ)
- …a dynamic organization that is focused on strategic and executional excellence. As an Associate Director , you will be working among the best in your profession ... success of training multiple market access field teams. The Associate Director will be responsible for driving...with key matrix team members including Marketing, Strategy and Operations , Legal, Regulatory , & Compliance, etc. +… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Temperature Strategy & Execution - 2406177829W **Description** Johnson & Johnson Innovative Medicine Research & Development (JJIM R&D), part ... of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director , Temperature Strategy & Execution within Clinical Supply Chain (CSC). The… more
