Designing programs for complete and accurate IND/CTA/NDA/MAA and other submissions and ensuring that clinical trials are designed to meet regulatory requirements * Contributing to the submission of product registration of new drugs, progress reports, supplements, amendments, aggregate reports and periodic adverse experience reports * Several years of clinical/industry/health authority or otherwise relevant experience, preferably in a global or at least European role * Experience leading submission of CTA, IND, sNDA/NDA/MAA/Variations * Experience in one or more of the therapeutic fields: Oncology, CNS, Cardio-Renal * Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) * Experience in working in, and communicating with cross-functional, multi-cultural project teams involving internal and external experts
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