- University of Pennsylvania (Philadelphia, PA)
- …interactions with nursing colleagues Serve as an expert in specialty area ( ex . Grant reviewer, editorial board, presenter) Participate in query and analysis of ... nursing research as a result of study team participation ( ex . Viral shedding studies for gene therapy and implications...new ideas Serve as a resource to the new investigator Clinical Practice Collects comprehensive data pertinent to the… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …amendments and information requests, Orphan drug applications, Annual Reports and Investigator 's Brochure + Assist in coordination and preparation for Agency ... be for you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …development RMPs, RMPs, etc.) and the review of clinical documents ( Investigator Brochures, protocols, clinical study reports, etc.) + Leads cross-functional Safety ... + Ability to apply and provide critical analysis of relevant FDA , EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities… more
- United Therapeutics (Silver Spring, MD)
- …and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, ... and ensuring the safety of enrolled subjects. Review and approve protocols, investigator brochures, and clinical trial reports in accordance with SOPs and good… more