Senior Medical Manager - Jiangsu Hengrui Medicine
Led medical management and project management responsibilities for regional or country-level clinical trials. Integrated medical science into clinical strategy, study design, clinical plans, and overall trial conduct. Provided medical support across Phase 1 to 3 studies spanning authorization, ethics submissions, medical monitoring, data review, vendor management, and regulatory writing support. • Owned cross-functional protocol authorization, EC submissions, and study start-up preparation • Contributed to statistical analysis plan inputs and safety management plan development • Managed medical monitoring, medical data review, and result interpretation/reporting • Supported timelines and budgets, study drug label and supply management, and NDA package writing