- Novo Nordisk Inc. (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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Genmab (NJ)
- …Director, External Data Quality Management, is a strategic leadership role within Clinical Data Management. This individual is accountable for driving the strategy, ... quality, and integrity of external data across the clinical trial portfolio. This role serves as a Subject Matter Expert (SME) in protocol quality, central and local… more
- Genmab (NJ)
- …with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical, and/or CROs, to enable expedited, predictive delivery for ... competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program.Key contributor to the study's… more
- Bristol Myers Squibb (Princeton, NJ)
- …cross-functional project management teams and projects within the Medical Affairs Cell Therapy Organization. This role reports directly to the Senior Director ... across the therapeutic within allocations provided. + Prepare detailed project plans, progress reports, and presentations for senior management and… more
- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs , Precision Medicine, you will help develop ... and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs, global registration, and market access. This role will operate on… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business ... on real-world evidence, and creating hope for all facing illness. The Manager , General Affairs , provides broad facilities management and office management… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality assurance, etc.) in pharmaceutical or ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works… 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
