Director, Global Medical Affairs, Gyn Oncology
Daiichi Sankyo Inc. - Basking Ridge, NJ
…and other cross-functional and regional stakeholders. Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in
Created: 2024-04-30
Manager, Regulatory Affairs - Solid Oncology
Regeneron Pharmaceuticals - Basking Ridge, NJ
…amendments and information requests, Orphan drug applications, Annual Reports and Investigator 's Brochure + Assist in coordination and preparation for Agency
Created: 2024-04-30
Associate Director, GMA Oncology
Daiichi Sankyo Inc. - Basking Ridge, NJ
…other cross-functional and regional stakeholders. + Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in
Created: 2024-04-30
Senior Director, Global Patient Safety - Ophthalmology
Regeneron Pharmaceuticals - Basking Ridge, NJ
…development RMPs, RMPs, etc.) and the review of clinical documents ( Investigator Brochures, protocols, clinical study reports, etc.) + Leads cross-functional Safety
Created: 2024-04-24
Director, Statistical Programming / Medical Analytics
Regeneron Pharmaceuticals - Basking Ridge, NJ
…PMR/PASS/PAES type of studies, disease/treatment registry type of studies, investigator -initiated studies/trials, and assessments of electronic health records like
Created: 2024-04-24
Research Data Coordinator
RWJBarnabas Health - Somerville, NJ
…monitors + Provides regular reports to Disease Specific Group members and Principal Investigator using OnCore + Acts as a liaison with study sponsors, scheduling
Created: 2024-06-11
Clinical Services Associate
Bausch + Lomb - Bridgewater, NJ
…planning, protocol development, essential document development, IRB submissions, CDAs and investigator agreements, and Trial Master File preparation and oversight +
Created: 2024-06-14
US Medical Director, Gastroenterology (Non-Alliance)
Sanofi Group - Bridgewater, NJ
…Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned immunology products. +
Created: 2024-06-03
Clinical Research Director, I&I
Sanofi Group - Bridgewater, NJ
…and other regulations + Review documents supporting clinical development such as Investigator 's brochure, regulatory documents for IND / CTA, clinical sections of
Created: 2024-05-26
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Clinical Research Director, Ophthalmology
Sanofi Group - Bridgewater, NJ
…packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of
Created: 2024-05-25
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