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Job Type
Full-time
Description
The Role:
The Medical Writer will serve as an important contributor to Sagimet Biosciences' Clinical and Regulatory Affairs teams, responsible for the creation, coordination, and delivery of high-quality clinical and regulatory documents. Reporting directly to the Chief Medical Officer, this individual will lead the writing of clinical study reports, regulatory submissions, and scientific communications in support of the company's Phase II and Phase III clinical trial programs.
The Medical Writer will bring a high degree of self-direction, scientific acumen, and regulatory writing expertise to every deliverable. This role requires close collaboration with Clinical Operations, Biostatistics, Regulatory Affairs, and external CRO partners, as well as the ability to translate complex scientific data into clear, accurate, and submission-ready documents that meet FDA, EMA, and ICH standards.
Essential Responsibilities:
- Author, edit, and finalize clinical study reports (CSRs) in accordance with ICH E3 guidelines for Phase II and Phase III clinical trials
- Lead the writing of regulatory submission documents, including IND amendments, NDA/BLA sections, briefing documents, and responses to FDA/EMA information requests
- Develop and maintain a broad range of clinical and regulatory documents, including protocols, protocol amendments, informed consent forms (ICFs), investigator brochures (IBs), and annual reports
- Collaborate with the Biostatistics team to ensure accurate interpretation and presentation of statistical results, tables, listings, and figures (TLFs) within regulatory documents
- Partner with Regulatory Affairs to ensure all written content aligns with applicable regulatory requirements, submission formats (eCTD), and agency-specific expectations
- Coordinate document review cycles across cross-functional stakeholders, incorporating scientific and regulatory feedback to produce final, approval-ready documents
- Develop and maintain document templates, style guides, and writing SOPs to support consistency and regulatory compliance across all written deliverables
- Manage timelines for multiple concurrent writing projects, ensuring on-time delivery of high-quality documents in a fast-paced environment
- Support preparation of scientific publications, abstracts, posters, and slide decks for medical conferences and peer-reviewed journals
- Assist in the preparation of Data Safety Monitoring Board (DSMB) packages, interim analysis reports, and safety narratives
- Contribute to the development of clinical development plans, integrated summaries of efficacy (ISE), and integrated summaries of safety (ISS) for regulatory filings
- Work with Clinical Operations to support the preparation of site-facing documents, including study manuals, training materials, and site communication letters
- Liaise with CROs and contract medical writing vendors to ensure quality and consistency of outsourced writing deliverables
- Maintain awareness of evolving regulatory guidelines and industry best practices in medical writing to continually advance document quality
- Support inspection and audit readiness by ensuring all documents meet archival and traceability standards
- Provide editorial review and quality check of documents authored by colleagues or external vendors
- Ensure all documents are completed in compliance with GCP, applicable SOPs, and regulatory requirements
- Assist with preparation of executive-level summaries and internal scientific communications as needed
- Maintain and organize document version control and submission-ready filing systems
- Other duties as assigned
Requirements
Education and Experience:
- Bachelor's degree required; advanced degree (M.S., Ph.D., PharmD, or M.D.) in a life sciences, biomedical, or related scientific field strongly preferred
- 5+ years of medical writing experience in a pharmaceutical, biotech, or CRO environment, with demonstrated experience on Phase II and/or Phase III clinical trial documents
- Proven track record authoring clinical study reports (CSRs), regulatory submission documents, and/or clinical protocols in accordance with ICH and FDA/EMA guidelines
- Strong understanding of ICH guidelines (E3, E6, E8, E9) and FDA/EMA regulatory submission requirements, including eCTD format
- Experience with CDISC data standards and ability to interpret statistical outputs, TLFs, and clinical datasets
- Excellent scientific writing, editing, and proofreading skills with exceptional attention to accuracy and detail
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) and document management/submission tools (e.g., Veeva Vault, eCTD publishing tools)
- Ability to manage multiple projects and deadlines independently in a resource-constrained startup environment
- Experience collaborating with cross-functional teams including Clinical, Regulatory, Biostatistics, and external CROs