- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …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
- Bristol Myers Squibb (New Brunswick, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Position: Senior Manager , Development to Launch Analytics** **Location** **: New ... questions and drive business strategy using advanced data science and analytics. The Senior Manager , Development to Launch Analytics will join a dynamic and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- 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. (Trenton, NJ)
- …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
- Bristol Myers Squibb (Princeton, NJ)
- …experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and ... key internal stakeholders and outside of BMS (functional and project leaders, peers and employees at all levels, vendors,...+ US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to… more
- Sanofi Group (Morristown, NJ)
- …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
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