- Sanofi Group (Morristown, NJ)
- …development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary ... Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of… 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 ... Brand Team (GBT) strategies + Liaise with Medical Study Leader to oversee investigator -initiated study (IIS) process from end to end including: Reviewing ISS and ESC… more
- Sanofi Group (Morristown, NJ)
- …abstracts and/or manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from ... scientifically sound and correctly conducted. + Prepare and review the interim investigator reports. + Lead the Dose Escalation Meeting and document decision making… more
- Sanofi Group (Bridgewater, NJ)
- …the CRD role: + Review and/or contribute in the the clinical section of the Investigator 's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP + Contribute on an ad hoc basis ... color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex,… more
- Sanofi Group (Morristown, NJ)
- …development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary ... color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex,… more