- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for leading RA team members involved in device project activities ... training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical ...strong and respected voice. + Comprehensive knowledge of US medical device regulations (FDA), Clinical Practice standards,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …position will report to the Senior Director , Strategy Lead of PAQ Oncology. The Director Medical Affairs - PAQ Oncology will support the US launch ... communicate data gaps, and work collaboratively with research teams ( Clinical Development, Medical Affairs Research,...share insights and evidence needs with the PAQ Oncology Medical Director * In collaboration with PAQ… more
- Ascendis Pharma (Princeton, NJ)
- …part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs , Advertising and Promotion. There is a preference for this ... together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs , Advertising and Promotion will be an internal expert on US FDA… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be local ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in developing and executing regulatory strategies… 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 Director of Strategy and Operations, serving as a strategic...a strategic and operational partner within the Cell Therapy Medical organization to deliver key portfolio priorities. Responsibilities include… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Principal Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications and post-approval life cycle maintenance phases. The… more
- J&J Family of Companies (Titusville, NJ)
- …regulatory affairs , data management, medical writing, biostatistics, global medical affairs , clinical pharmacology, clinical operations, health ... ideas to assist in identifying new market opportunities** **Support general Clinical / Medical Affairs activities involving product evaluation, labeling… more
- Merck (Rahway, NJ)
- …in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...percent of the time to manage future or ongoing clinical research projects. Provide scientific and medical … more
- Bausch + Lomb (Trenton, NJ)
- …with relevant global team members, other B&L departments (eg, R&D/Project Management, Clinical / Medical Affairs , Biometrics, Regulatory Affairs , Quality ... study objectives are being met and provide the operations director and/or senior management with timely updates on progress...completed in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs … more
- Sanofi Group (Morristown, NJ)
- …to submit to genetic testing) or any other characteristic protected by law. The Clinical Research Director (CRD) provides medical and scientific expertise to ... **Job Title:** Clinical Research Director - RBD **Location:**...CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of… more