- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …uniting the best of both worlds to develop new medicines for patients. The Position As Senior Medical Director for the liver disease team, you will be part of ... this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the… more
- Tris Pharma (Monmouth Junction, NJ)
- …Collaborate with all Tris functions that contribute to the partnership, including R&D, Regulatory , CMC , Finance, Legal, and more. Understand their roles, their ... some combination across technical (eg, research, product development, clinical development, regulatory , CMC ) and business (eg, business development, alliance… more
- Bristol Myers Squibb (Princeton, NJ)
- …documents to support Health Authority submissions. **Position Summary** The Global Regulatory CMC Operations & Policy Senior Director will manage a team ... they relate to GRS- CMC responsibilities. The Global Regulatory CMC Operations & Policy Senior Director will also be responsible for driving CMC … more
- Novo Nordisk (Princeton, NJ)
- …Are you ready to make a difference? The Position Reporting to the Senior /Executive Director or Vice President of Regulatory Affairs, the Director of ... on GMP compliance-related activities. May supervise others. Relationships Reports to the Senior /Executive Director or Vice President, Regulatory Affairs.… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes...effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior … more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Organon & Co. (Lansdale, PA)
- …Description** **The Position** Reporting to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls ( CMC ) New Products, the ... for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but… more
- Novo Nordisk (Plainsboro, NJ)
- …therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Medical Director Work with the Clinical Operations, Non-Clinical ... ready to make a difference? The Position The Medical Director serves as the subject matter expert for our...Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be… 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 ... and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your expertise will play...Proposal (RFP) through contract execution for clinical studies and CMC projects as well as ongoing governance with key… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ).** **Expert level skillset ... to treat serious and often rare conditions. Could you be our next Associate Director , R&D Project Planning Capability Lead? This position is located in our King of… more
- Merck (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Integra LifeSciences (Plainsboro, NJ)
- … agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel ... system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management...quality and regulatory compliance. + Works with Senior Management to achieve alignment of Quality Goals and… more
