- Glycomine (Boston, MA)
- …in the quality of life for patients, caregivers, and families. Job Description The Senior Clinical Project Manager /Clinical Project Manager is a team-player ... through all phases of clinical trials (Phase I-III). The Senior Clinical Project Manager /Clinical Project Manager...with relevant team members involved in study set up ( CMC , Reg, etc). Ensure timeline collection of all start-up… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies ... individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. Represents and supports… more
- Vertex Pharmaceuticals (Boston, MA)
- Job Description General/Position Summary The Director, CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the ... inspection management related to CMC activities of the internal manufacturing site for Cell...work in a dynamic environment and communicate effectively with senior leaders. Other Requirements 5% travel may be required.… more
- WuXi AppTec (Boston, MA)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager / Senior Manager , CMC Project Management.** This position ... will be responsible for managing DS and DP projects within STA. The position will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- Takeda Pharmaceuticals (Lexington, MA)
- …on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies ... manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + Represents and… more
