- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager ** **Location: Cambridge, MA (Hybrid)** **About the ... role:** As a CMC Project Manager , you will provide project management expertise to CMC LCM activities for Takeda's small molecule portfolio. You will… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …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 (Providence, RI)
- …Analytics, Data Governance, Digital Literacy, Digital Transformation, Informatica Metadata Manager , Management Process, Process Flow Documentation, Project ... implement the approach of structured content management. They will also support project management activities to ensure efficient execution and compliance within … more
- Shuvel Digital (Boston, MA)
- …Certifications + IT and Technology-Specific Certifications + Certified Information Systems Project Manager (CISPM) + ITIL Certification (Information Technology ... Project /Program Manager Boston, MA - Hybrid... Project /Program Manager Boston, MA - Hybrid (Remote and In...Infrastructure Library) + Certified Management Consultant ( CMC ) + Leadership in Energy and Environmental Design (LEED)… more
- AbbVie (Worcester, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The MES Program Manager is an experienced leader responsible for managing large global projects ... multiple manufacturing locations. This individual provides leadership and coordinated project management for all manufacturing and/or technical activities needed to… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …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. (Providence, RI)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Takeda Pharmaceuticals (Boston, MA)
- …The GPL ensures through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope & objectives, budget and ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- Sanofi Group (Northborough, MA)
- …planned with the right coverage targets as defined by Policy or Critical Material Manager (GSP) in case of exceptions / deviations * Reporting of deviations to ... coverage targets to Critical Material Manager (GSP) + Reviews SAP requisitions or Site Scheduler...and purchasing systems in a CGMP manufacturing environment + Project management skills + Expertise in document management systems… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of complex ... the regulatory requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA guidance… more