Tokyo Sandoz ¥3,000,000 - ¥6,000,000 per year
Job Description

Review 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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