- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working relationships with… more
- Bristol Myers Squibb (Princeton, NJ)
- …leads matrixed cross-functional project management teams and projects within the Medical Affairs Cell Therapy Organization. This role reports directly to the Senior ... across a matrix. + Experience with drug development, commercialization, and healthcare, clinical trial management a plus. The starting compensation for this job is… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality ... assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high… more
- Bausch Health (Bridgewater, NJ)
- …drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products. ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in accordance with… more
- Bausch Health (Bridgewater, NJ)
- …our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned ... Authority requirements and timing for submissions + Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities +… more
- Bausch Health (Bridgewater, NJ)
- …drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory development and post-approval regulatory activities ... Authority requirements and timing for submissions + Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Veterans Affairs, Veterans Health Administration (Vineland, NJ)
- …and symptoms and/or changes in patients' condition and notifies the RN Care Manager (RNCM); promptly seeks the assistance of the RNCM or provider e. Demonstrates ... practices. h. Documents care appropriately in CPRS, and clears all clinical reminders; completely performs health history screenings per templated note, completes… more
- Bristol Myers Squibb (Princeton, NJ)
- …studies within the evidence generation Oncology/Hematology portfolio (including Medical Affairs Sponsored studies [MAST], Clinical Research Collaborations ... clinical accountability and oversight for the various medical affairs -led sponsored studies (interventional and non-interventional), in alignment with the… more
- Stryker (Mahwah, NJ)
- …States. In your role as a Staff Clinical Evaluation Specialist on the Clinical Affairs team, you will lead the process of planning, writing, and updating ... specialized indications and techniques. + Acts as the dedicated Clinical Evaluation Project Manager , driving the establishment...+ A minimum of 2 years in a Regulatory Affairs role required. + Experience in scientific writing, performing… more