- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. **SUMMARY** The Senior Quality Compliance Manager will lead, coordinate and perform corporate audits ... communication skills should create instant credibility with auditees and senior management while helping deliver the audit program...+ Experience working for regulatory agencies (such as US FDA , MHRA, TGA, Health Canada, SFDA, ANVISA, US state,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …of possible** with us. **Job Summary:** We are seeking a highly experienced and visionary Sr . Software Manager to lead and inspire a team of talented software ... to implementation, testing, and deployment, adhering to medical device regulations (eg, FDA , ISO 13485). + Define and implement software development best practices,… more
- Taiho Oncology (Princeton, NJ)
- …Employee Value Proposition: Embark on a transformative journey with Taiho Oncology as a Senior Manager , Global Labeling and PV Operations. At the forefront of ... based on your experience in our rapidly evolving organization. Position Summary: The Senior Manager , Global Labeling Innovation & PV Operations, leads the… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Embark on a transformative journey with Taiho Oncology as a Senior Manager in PV Sciences. At the forefront of pharmacovigilance innovation, ... on your experience in our rapidly evolving organization. Position Summary: The Senior Manager , PV Sciences role will support medical surveillance activities… 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 ... service providers. Support and participate at regulatory audits, such as state inspections, FDA audits, QA audits, etc. + Monitor the new regulation and industry… more
- Taiho Oncology (Princeton, NJ)
- …and manages complex global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical studies ... judgment. + Knowledge of, and competence in, application of FDA /GCP/ICH guidelines. + The incumbent in this position may...(as well as any other discretionary payment or compensation program ) at any time, including for reasons related to… more
- Bristol Myers Squibb (Summit, NJ)
- …sampling and testing, and overall contamination control program for the site. The Sr . Manager Sterility Assurance is responsible to act as the SME during ... of SOPs, forms, and methods required to support the compliant operation. + The Senior Manager , Sterility Assurance plays a critical role in ensuring the… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The Senior Manager , Hematology, Clinical Scientist leads...and interpretation of study data of a clinical development program . The Sr . Manager leads ... development projects through early and/or late phase development. The Sr . Manager reports to the Director, Clinical...and deliver on clinical studies and programs. As a Senior Manager in Hematology Clinical Sciences, a… more
- Stryker (Mahwah, NJ)
- ** Senior Manager , Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the ** Senior Manager , Regulatory Affairs** , you ... compassionate use pathways. + Direct interactions with health authorities (eg, FDA , EU Notified Bodies) and guide internal teams through regulatory communications.… more
- Novo Nordisk (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... We are seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation management… more
