- Gilead Sciences, Inc. (Santa Monica, CA)
- …patient safety , regulatory compliance, and scientific excellence across the product lifecycle. **Key Responsibilities** + Lead ongoing safety signal ... clinical trials and postmarketing settings. + Serve as the primary author of safety sections in protocols, Investigator 's Brochures, CSRs, DSURs, RMPs, and… more
- Navy Exchange Services (NEX) (Pearl Harbor, HI)
- Title: ASSET PROTECTION/ SAFETY INVEST ASST (TRAINEE) (RFT/MAIN STORE) Location: United States-Hawaii-Pearl Harbor Job Number: 250003BW Job Summary: Assist higher ... graded LP/ Safety Investigators in performing investigative duties at a Navy... which will enable associate to assume an NF-2 Investigator position at a Navy Exchange. - Monitors the… more
- University of Pennsylvania (Philadelphia, PA)
- …manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn), regulatory bodies (both internal and ... functions independently with minimal supervision on complex protocols that are Investigator Initiated. The Regulatory Affairs Specialist C authors and conducts… more
- Covenant Health Inc. (Knoxville, TN)
- …protocol and regulatory requirements, manages patient protocol activities, assures patient safety , collects records and maintains data and source documentation. The ... population and anticipated recruitment, considering the ability to maintain the rights, safety , and well-being of the patient and serving as the liaison between… more
- J&J Family of Companies (Horsham, PA)
- …the US Medical Affairs Immunology team, where you will influence product development, scientific communication, and evidence generation efforts, ensuring alignment ... development, regulatory communications, academic and community-based IBD HCP and investigator interactions, support of execution, and supervision of clinical studies… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Epidemiology, early and late-stage Clinical Development teams, Regulatory Affairs, Drug Safety , Marketing, PPSS ( Product Pipeline Scientific Support), Corporate ... Statements, Investigator Brochures, Clinical Overviews. Contributes to PSURs (Periodic Safety Update Report), ASRs (Annual Safety Report) and Company Core… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …+ Assisting in the coordination and planning of meetings (eg Investigator Meetings, Kick-off meetings). + Conducting monitor training. + Performing ... Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes. +… more
- Sanofi Group (Morristown, NJ)
- …under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver ... and propose related corrective action plans + Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access… more
- Gilead Sciences, Inc. (Foster City, CA)
- …are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical ... + Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products. + Provides… more
- Gilead Sciences, Inc. (Foster City, CA)
- …monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality ... part of a cross-functional team + Lead the development of the target product profile and clinical development plan for assigned molecules /products considering both… more