- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation ... of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality,… more
- Merck (Boston, MA)
- …Analytics, Data Governance, Digital Literacy, Digital Transformation, Informatica Metadata Manager , Management Process, Process Flow Documentation, Project ... Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring Business Analyst, will optimize regulatory authoring… more
- Takeda Pharmaceuticals (Lexington, MA)
- …approaches to reduce COGs and strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you PM support). + ... Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… 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
- 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 - Oncology, Solid Tumors...through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &… more
- AbbVie (Worcester, MA)
- …difficult decisions regarding priorities among projects. + Effectively communicate and present project status to Operations senior management and stakeholders + ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The MES Program Manager is an experienced leader responsible for managing large global projects… more
- Sanofi Group (Waltham, MA)
- …with other internal and external stakeholders (such as R&D compliance, Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior ... diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D… more