To provide high quality expertise on preclinical safety (Toxicology and Safety Pharmacology) to Global Product Teams (GPTs).You are accountable for the management of pharma projects (small molecules and biologics) beginning at Exploratory Development (ED) through marketing authorization and life cycle management (LCM). To analyze results of in silico, in vitro and in vivo toxicology as well as safety pharmacology studies and bibliographic data, put it into strategic perspective and create preclinical safety assessments.
You will compile preclinical safety parts of all regulatory documents including clinical trial applications (IND/IMPDs), global marketing authorization applications (e.g. BLA/NDA) and other filings. To support delivery of high-quality contributions in incoming requests from other functions within the organization and Health Authorities. You will contribute to activities for due diligence evaluations.
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