- 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 the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, ... rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global...will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, ... hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient… 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
- 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
- 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
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