- 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
- 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
- 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
- J&J Family of Companies (Titusville, NJ)
- …more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a ** Senior Manager , Product Artwork Technical & Automation to join our ... They will continuously report progress, challenges, and achievements to senior leadership and stakeholders. **Qualifications:** **Education:** . Bachelor's degree… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good ... Participate in regulatory inspections and assist in preparing response documentation. **Audit Program Execution** + Contribute to the development of the annual audit… 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 ... overall management of vendor operations and all projects related to the program . This position specializes in contact center patient support inclusive of digital,… more