Position Overview
Responsibility:
Ensure that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles. Perform product evaluation, regulatory strategy and gap analysis, as well as protocol design and development. Responsible for CSR, clinical investigator's brochure, CTD, submission e.g. IND, NDA …, integrated report, annual update, and special science report writing. Demonstrate a strong ability in scientific literature search, review, and information integration. Complete other tasks or assignments requested by the director. Requirement: Preference will be given to candidates with a PhD in life sciences and experience studying abroad. Required working experiences: biotech or pharma for more than 5 years. Experience with regulatory requirements for various types of clinical document writing, preparation, or review. Well understandings...