Associate, Non-Clinical & Clinical Group
Posted: Oct 19, 2025
Job Description
Job DescriptionReview and evaluate non-clinical/ clinical data Plan clinical development strategy with assistance from manager and global team Prepare documents for PMDA consultation in collaboration with local regulatory affairs and global team Execute and report bioequivalence studies, pharmacodynamic studies and clinical endpoint studies with healthy subjects and patients in accordance with GCP and other regulatory requirements with assistance from Manager Vender Management with assistance from manager Prepare submission dossier non-clinical and clinical part with assistance from manager and global team Prepare answers to deficiency letters from PMDA with assistance from manager and global team Management and archive relevant documents Support market team after getting approval with assistance from manager
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