- Sumitomo Pharma (Trenton, NJ)
- …https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The ** Associate Director , Commercial Drug product Manufacturing and Packaging** ... assigned projects to coordinate technology transfer and development efforts per project milestones, timelines, and deliverables for projects. + Reviews and… more
- Bristol Myers Squibb (Princeton, NJ)
- …Requirements + Advanced Degree in related field (MS, Ph.D. or PharmD) + For Associate Director with Ph.D. approximately 5+ years of experience with demonstrated ... are supported.The CP&P team interacts with discovery and translational scientists, project leadership, early and late clinical development teams and commercial… more
- System One (Basking Ridge, NJ)
- Job Title : Associate Director , Clinical Safety Scientist (Contingent Worker) Job Schedule: Candidate can work 100% remote - preference would be EST/CST based ... and cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communication + Ensures consistent and unified safety… more
- Merck (Rahway, NJ)
- …and routes of administration, including inhalation, implantation, and injection. The Associate Principal Scientist will lead the definition and execution of design ... performed by external partners. + Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, design… more
- Merck (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Bristol Myers Squibb (Princeton, NJ)
- …to regulatory submissions. This individual will work on cross-functional project teams to drive execution of translational/biomarker plans working with disease ... with Biomarker Lead late stage clinical trials for Phases II/III preferred. Regulatory submissions drug approvals in solid tumor space also highly desirable.… more
- Bristol Myers Squibb (Princeton, NJ)
- …across the organization, including medical safety assessment, clinical development, global regulatory , epidemiology and others. The SBRA Lead will drive functional ... the benefit-risk assessment function, aligning with organizational goals and regulatory requirements. + Lead the benefit-risk assessment process across therapeutic… more
- Sumitomo Pharma (Trenton, NJ)
- …of the problems. + Act as a liaison between statistical programming, subcommittees and project teams as + undefined + May serve as an external spokesperson for the ... using SAS + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc. + Executing Pinnacle… more
- CenterWell (Trenton, NJ)
- …a part of our caring community and help us put health first** The Medical Director , Primary Care relies on medical background and reviews health claims. The Medical ... Director , Primary Care work assignments involve moderately complex to...be authorized. All work occurs with a context of regulatory compliance, and work is assisted by diverse resources… more
- Humana (Trenton, NJ)
- …a part of our caring community and help us put health first** The Medical Director relies on medical background and reviews health claims. The Medical Director ... or data requires an in-depth evaluation of variable factors. The Medical Director actively uses their medical background, experience, and judgement to make… more