- United Therapeutics (Research Triangle Park, NC)
- …to success. The Senior/Medical Writer will support Global Medical Affairs Phase 3b/4 research as well as early phase product development . Work independently to ... modules (eg, CTD sections). Provide strategic input into document planning and content development to ensure alignment with clinical and regulatory goals. +… more
- Sanofi Group (Colorado Springs, CO)
- …when requested. + Collaborate, as directed, with Commercial Operations, Business Development , Regulatory , etc. to facilitate diligence reviews, medical and ... that contribute to enhancement of Sanofi's key medical messages, plans and future research . + Keep abreast of medical and scientific developments in the therapeutic… more
- University of Virginia (Charlottesville, VA)
- …and tenure status will be dependent upon qualifications. This position is 75% research and 25% clinical. The successful candidate will have a strong commitment to ... improving the fundamental understanding of diabetes by promoting translational research efforts that will serve as the future basis for novel preventive, diagnostic,… more
- BeOne Medicines (Emeryville, CA)
- …Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports ... the impact to applicable safety documents or safety section of clinical or regulatory documents. + Lead strategy development , analysis, and response to safety… more
- Pfizer (New York, NY)
- …integrity and quality of clinical trial(s) in support of the development strategy for programs within our Late-Stage Oncology portfolio. **KEY RESPONSIBILITIES** ... + Clinical development expert for assigned studies maintaining current scientific and...authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …that advance our progress. **EXAMPLE RESPONSIBILITIES:** + Provides input into product development strategies and/or research or clinical development plans ... CROs, and bioanalytical input into clinical study reporting and regulatory filings. You will typically play a lead scientific...and with cross-functional project / program teams in drug research or development . + Multiple years' experience… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …with internal colleagues in the Global Medical Department, Marketing, Sales, Research and Development , strategy/portfolio management, Regulatory Affairs, ... and expertise by fostering relationships with outside organizations/experts to support research programs, clinical development programs and licensed product… more
- IQVIA (Durham, NC)
- …as flexible schedules. + Collaborating with motivated, high-performance, statistical and research teams + Technical training and tailored development curriculum ... **Job Level:** FSP Principal Biostatistician for RWE Research **Location:** Home-based in the US or Canada...responsible for providing full range statistical support for drug development based on real world evidence (RWE). **Additional Benefits:**… more
- Amgen (Cambridge, MA)
- …product delivery team leaders in Operations, Therapeutic Area heads, all Process Development groups, Regulatory , Quality and with Clinical and Commercial ... you'll help make a lasting impact on the lives of patients as we research , manufacture, and deliver innovative medicines to help people live longer, fuller happier… more
- Chiesi (Cary, NC)
- …real-world evidence (RWE) research efforts. This role is well-suited for recent PhD graduates or senior graduate students with strong research skills and a ... + Strong communication skills, with experience in scientific writing and presenting research findings. Education PhD (or current senior graduate student) in… more
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