Senior Medical Writer

Role: Senior Medical Writer supporting Sagimet Biosciences' clinical and regulatory documentation for Phase II and III trials. Responsibilities: authoring and editing CSRs, regulatory submissions (IND, NDA/BLA), protocols, ICFs, IBs, and reports; collaborating with Clinical Operations, Biostatistics, Regulatory Affairs, and CRO partners; ensuring compliance with ICH, FDA, EMA, eCTD standards; managing document review cycles, templates, and SOPs; supporting publication and safety documentation; maintaining document control and audit readiness. Requirements: Bachelor's degree; 5+ years in pharmaceutical/biotech/CRO medical writing, with experience in Phase II/III studies; proven expertise in CSRs and regulatory documents per ICH/FDA/EMA; strong understanding of ICH guidelines, eCTD, CDISC data standards; excellent scientific editing and proofreading; proficiency in Microsoft Office, Veeva Vault, and submission tools. Preferred: advanced degree (M.S., Ph.D., PharmD, M.D.); experience with clinical development plans, safety narratives, and cross-functional teamwork. High-Value: focus on clinical/scientific communication for biotech/pharma, regulatory compliance, GxP standards, and document management in a fast-paced environment. WorkSetup: not specified.