- WuXi AppTec (Natick, MA)
- …Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …requirements for CMC and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance and perspective ... Provide CMC regulatory strategy input and expertise in the...marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka's products are developed/maintained in… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of global ... of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC , etc.) to contribute to global regulatory plans, address global regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …into issues and develops contingency plans; communicates timely and proactively project -related issues to senior executive management and manages issues ... and empower you to shine? Join us as a Senior Director, Global Program Leader (GPL) in our Cambridge...through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &… more
- Takeda Pharmaceuticals (Lexington, MA)
- …progress; manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + ... ensure accurate information, timelines and budgets are completed to support project recommendations to Senior Management. + Generates collaboration, cooperation… more
- Takeda Pharmaceuticals (Boston, MA)
- …into issues and develops contingency plans; communicates timely and proactively project -related issues to senior executive management and manages issues ... role is defined by Takedas' values of Patient-Trust-Reputation-Business. In addition to project specific responsibilities, the ED GPL may be called upon to represent… more