Eli Lilly and Company seeks a Research Scientist – Benefit Risk (R5-R6) to provide benefit-risk assessments (B-RA), consultation, and policy issue development across drug development lifecycle. Develop scientific standards, best practices, study plans, and scientific tools to facilitate B-RA for Lilly compounds in early development, peri- and post-approval. Develop and maintain a systematic B-RA framework suitable for inclusion in strategic planning and regulatory interactions. Represent Lilly on selected external B-RA working groups as needed to understand and maintain awareness of developing and ongoing initiatives (policies, practices, guidance, regulations, etc.) at the FDA, EMA, and other regulatory agencies as it relates to B-RA. #LI-DNI Position requires a Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related field and 3 years of scientific experience in epidemiology, program evaluation, health behavior, health education and/or clinical development. Experience must include a minimum of: 2 years of experience in developing and executing benefit-risk assessments of medicinal products; 2 years of experience in risk management programs and activities; 2 years of experience in supporting regulatory submissions to FDA/EMA with focus on analytic review and /or clinical study protocol review; 2 years of experience in post-approval B-RA activities; and 2 years of experience in understanding and communicating various aspects of delivery of healthcare. Part time telecommuting may be permitted. #LI-DNI JOB LOCATION: Indianapolis, IN. To apply, please visit and enter job requisition number R-88242 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285. Eli Lilly
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