- J&J Family of Companies (Raritan, NJ)
- …to treatment and supports the interpretation and reporting of results + Assists Regulatory Affairs in determining requirements for any corrective actions or ... in conjunction with other clinical team members + Assists Regulatory Affairs in the development of drug...preferred + Significant experience with managing/ supervising clinical trials, medical and data monitoring clinical research programs… more
- Bristol Myers Squibb (Princeton, NJ)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... personal lives. Read more: careers.bms.com/working-with-us . **Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** The selected candidate will… more
- Bristol Myers Squibb (Princeton, NJ)
- …Access objectives + Work as part of cross-functional teams-including clinical development, medical affairs , regulatory , and biostatistics-to ensure HEOR ... counterparts in the development and review of eCOA documentation, including data model specifications, project plans, user acceptance testing scripts, device… more
- Sanofi Group (Morristown, NJ)
- … authorities. + The CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value proposition and ... on opportunities. + The CRD will liaise with the Medical Affairs group to contribute to activities...Strong analytic thinking and the ability to assess scientific data and medical literature + Excellent written… more
- Sumitomo Pharma (Trenton, NJ)
- …including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is ... and ensure patient safety. + Assist in signal detection activities including data assembly, signal validation, and signal evaluation. + Perform literature monitoring… more
- J&J Family of Companies (Raritan, NJ)
- …within GCDS verticals, and with cross-functional and regional partners from Global Medical Affairs , Global Market Access, Global Marketing, Global Epidemiology, ... J&J Technology Data Sciences, Janssen R&D Data Science, reginal medical affair and evidence...cross-functional franchise teams with internal partners such as Global Medical Affairs , Global Market Access, Global Marketing,… more
- System One (Park Ridge, NJ)
- …+ Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements ... hands-on testing when necessary. Your expertise will directly impact product safety, regulatory success, and speed-to-market for critical medical devices and… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more} **Preferred… more
- J&J Family of Companies (Titusville, NJ)
- …scientific analytic projects in collaboration with cross-functional partners including Scientific Affairs , Medical Affairs , Strategic Customer Group, and ... APIs for model serving (eg, RESTful APIs, FastAPI, Flask). + Awareness of data security, regulatory standards, and best practices for privacy. + Experience… more
- Merck (Rahway, NJ)
- … Analysis, Drug Development, Ethical Standards, Intellectual Curiosity, Management Process, Medical Research, Regulatory Affairs Compliance, Regulatory ... + Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development… more