- Merck & Co. (Rahway, NJ)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content Understanding of CMC operations, ... to regulatory documentation.- - - Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring Business… more
- Integra LifeSciences (Plainsboro, NJ)
- …through Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend ... Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …or continued marketing. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (eg, ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- Merck (Rahway, NJ)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... source systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… 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 ... submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors...of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- Sanofi Group (Morristown, NJ)
- …Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior manager of the TED team or Research lead, participates in project ... 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
- Merck (Rahway, NJ)
- …Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and ... **Position Description/Summary:** The GPAM Associate Director, Value & Implementation Project Manager (VIPM), is a core member of Value & Implementation (V&I)… more
