- Gilead Sciences, Inc. (Parsippany, NJ)
- …regarding audit outcomes and CAPAs. Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership ... helping deliver life-saving therapies for unmet needs. We bring our passion for science , discovery, and creative thinking into everything we do. We are an inclusive… more
- Bristol Myers Squibb (Princeton, NJ)
- …to evolve biotransformation capabilities within the department and contribute to science through conference presentations and publication of new findings. Basic ... years of academic and / or industry experience OR PhD or equivalent advanced degree in the Life Sciences...strategies in 14C human ADME studies. + Understanding of regulatory requirements in the areas of drug metabolism, drug-drug… more
- J&J Family of Companies (Raritan, NJ)
- …Innovative Medicine is informed and inspired by patients, whose insights fuel our science -based advancements. Visionaries like you work on teams that save lives by ... Marketing, Global Epidemiology, J&J Technology Data Sciences, Janssen R&D Data Science , reginal medical affairs, evidence generation functions, and others. **You… more
- Merck (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs. The AVP provides leadership and direction through senior-level and… more
- Bristol Myers Squibb (Princeton, NJ)
- …pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier / submissions; and assist in developing strategy for the ... DSUR, etc. to support clinical trials and global registrations. Interacts with regulatory authorities to address questions as needed. + Support clinical assets for… more
- J&J Family of Companies (New Brunswick, NJ)
- …dossiers, manuscripts, and conference abstract/poster presentations. **Qualifications:** + A PhD in Biostatistics, Data Science , Epidemiology, Health Services ... and epidemiologic research to support post-market safety and effectiveness, regulatory submissions, product development, product launches, value assessments, predictive… more
- Merck (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... to individual contributors + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics and authoring … more
- Taiho Oncology (Princeton, NJ)
- …collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types ... Employee Value Proposition: At Taiho Oncology, we are leaders in cutting-edge science and technology, from chemistry to pharmacokinetics. This expertise and our… more
- Sanofi Group (Morristown, NJ)
- …an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and ... of sanofi revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. + He/she: Creates and executes a… more
- Merck (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses + Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory … more