Associate, Non-Clinical & Clinical Group

Job Description Summary

For both Sandoz small molecule and biosimilar, under direction/ leadership by manager, review of non-clinical/ clinical data, participation in development strategy discussion, execution and reporting of clinical studies, preparation of submission dossier, interaction with PMDA during review period, and acquisition of approvals as schedule.

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 

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Data Management, Detail-Oriented, Health Sciences, Lifesciences, Negotiation Skills, Project Planning, Waterfall Project Management