- Sumitomo Pharma (Trenton, NJ)
- …reports + Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing ... for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator … more
- J&J Family of Companies (Raritan, NJ)
- …+ Work with business partners including but not limited to R&D, Clinical Research , Regulatory Affairs, Communications, Legal, Quality & Compliance, Preclinical, ... for the development of materials to be used for clinical study execution ( investigator brochures, training materials,...with Medical Safety team to ensure adverse events from clinical research studies are reviewed, trended and… more
- Mount Sinai Health System (NJ)
- …oncology research at VHMSCCC + Support the development and implementation of a clinical research strategy with the VHS research leadership + Collaborate ... a working relationship with investigators and the leadership of Clinical Research at the Tisch Cancer Institute...of Health funding and in the 99th percentile in research dollars per investigator according to the… more
- IQVIA (Parsippany, NJ)
- …such as Power BI and Spotfire. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life ... and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life… more
- Sanofi Group (Morristown, NJ)
- …guidance and serving as the key liaison between global Medical, the Principal Investigator (PI), and the US Medical Team on Sanofi-sponsored studies, as delegated by ... Identify, establish, build, grow, and maintain strategic relationships with senior experts, key opinion leaders (KOLs), professional societies, immunization advisory… more
- Bristol Myers Squibb (Princeton, NJ)
- …oversees evidence generation for the Oncology Solid Tumors portfolio, including Clinical Research Collaborations (CRCs), Medical Affairs Sponsored Studies ... (MAST), and Investigator -Sponsored Studies (ISRs), ensuring alignment with internal strategies to...and drive strategies to accelerate the development of BMS's clinical development pipeline leveraging external research platforms,… more
- Bristol Myers Squibb (Princeton, NJ)
- …and real-world evidence (RWE) studies, including early signal-seeking studies, investigator -sponsored research (ISR), medical affairs-led studies, post-market ... worldwide. The WW-DAH will collaborate closely with cross-functional teams, including Research & Development, Commercial, and Market Access, to maximize the value… more
- Merck (Trenton, NJ)
- …simultaneously + Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release ... the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. **Key functions:** + Reports… more
- System One (Park Ridge, NJ)
- …device, cosmetic, disinfectant (EPA, DIN) and general household products areas. The Senior Writer will lead and drive the technical (CMC) writing to accelerate ... or exceed quality standards. + Drafts eCTD written and tabulated summaries, investigator brochure content, FDA briefing packages, and other agency related technical… more
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