Senior Medical Writer - Shanghai/Beijing
On-site · Shanghai, Shanghai, China or Beijing, Beijing, China
Job Summary
Lead the clear and accurate completion of medical writing deliverables across studies, coordinating activities within and across departments with minimal supervision. Author and review documents including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, safety/update reports, clinical development plans, NDA/eCTD submissions, journal manuscripts, abstracts, posters, and presentations. Ensure compliance with regulatory standards (ICH E3, SOPs, templates, authorship and style guides) and coordinate quality/editorial reviews. Act as a peer reviewer for internal teams, review statistical analysis plans and table/figure/listing specifications, interact with clients and cross-functional colleagues (data management, biostatistics, regulatory affairs, medical affairs) to produce high-quality writing deliverables, conduct online literature searches, mentor less experienced medical writers, and develop deep topic expertise while working within budget specifications.
Required Qualifications
- Bachelor's degree in a relevant discipline with relevant writing experience
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
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