- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...& variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disclosure for collection, retention, testing and retesting of samples + Project Team Participation: Provide device-specific regulatory insight/guidance during ... around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional ... together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds,...direct reports. + Provides matrix management and leadership to project teams. + Provides accurate and thorough input and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Statistical Project Leader - Associate Director **Location:** Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future ... accelerate progress. Join our **Biostatistics Immunology & Inflammation team as Statistical Project Leader ( Associate Director )** and you'll provide… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Merck (Rahway, NJ)
- …Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, ... and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Director , Statistical Programming, provides functional expertise and ... leadership to clinical project teams to lead statistical programming teams and support...technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development and implementation… more
- AbbVie (Florham Park, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Statistics - Eye Care provides statistical leadership ... trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts...or those of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide… more
- Sanofi Group (Morristown, NJ)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... and is accountable to develop and maintain device aspects of project regulatory strategy documents. The incumbent will provide strategic and tactical support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Laboratory Data Management is accountable for the ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… more