- Sanofi Group (Morristown, NJ)
- …guidance to internal Sanofi customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to ... work in close partnership with other departments including brand teams and Public Affairs + Play a leadership role in developing, executing, and contributing to the… more
- J&J Family of Companies (Titusville, NJ)
- …expertise with multiple components of drug development, such as translational research, clinical studies, or regulatory interactions. + Working knowledge of ... work to a wide audience. + Prior experience serving on multifunctional teams delivering clinical trials in an R&D or Medical Affairs setting. Preferred: +… more
- AbbVie (Florham Park, NJ)
- …management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs . The Associate ... development and drive alignment with functional management. Partner with other functions ( Clinical , Regulatory , Patient Safety, or GMA) to create development… more
- AbbVie (Florham Park, NJ)
- …life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The ... development and drive alignment with functional management. Partner with other functions ( Clinical , Regulatory , Patient Safety, and GMA, etc.) to create… more
- Merck (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be… more
- Ascendis Pharma (Princeton, NJ)
- …compliance audits. . Functions as a patient safety advisor to Ascendis Clinical Development Organizations, Medical Affairs , Commercial Organizations and PV ... all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management.… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …The ideal candidate will have a strong background negotiating agreements related to pre- clinical and clinical research (international experience a plus) in the ... and will provide legal support and assistance for various R&D and regulatory -related activities. This role requires frequent interaction with leadership and other… more
- J&J Family of Companies (Raritan, NJ)
- …to improve patient outcomes. + Collaborate closely with cross-functional partners (eg regulatory , medical affairs , market access, R&D, etc.) to facilitate ... and ITI-1284 and will be a strong partner with R&D, Global Medical Affairs , and the Regions to deliver these innovative therapies worldwide. Key responsibilities… more
- System One (Park Ridge, NJ)
- …+ Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements ... technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization.… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... Deep knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. **Competencies**… more