Responsibilities： * Serve as medical writing lead for clinical trial-related clinical and regulatory documents * Write, review, and/or edit publications (manuscripts, abstracts, slides/poster presentations, etc.) * Support the preparation of writing content of clinical trial-associated documents for new and ongoing programs * Drive document writing and review processes * Develop and maintain timelines for document generation, revision, and completion, with collaboration with other project team members * Coordinate and manage review cycles, incorporate team comments, and lead discussions on document revision and finalization * May manage outsourced writing/translation projects with minimal supervision * Assist in maintenance of SOPs and writing tools, such as templates and style manuals * Perform QC checks on document content
Qualifications： * Master/PhD/MD in life sciences preferred; other relevant fields considered * ≥2 years of regulatory and medical writing experience preferred, with clinical trial protocols, investigator’s brochures, clinical study reports, safety narratives, other safety reports, publication, briefing book, or CTD clinical summaries * Demonstrated advanced writing skills, with strong command of Chinese and English language and grammar * Demonstrated understanding of clinical research, the drug development process, and applicable China, US, and international regulatory guidelines * Proficiency with MS Office Suite, Endnote, and templates * Ability to work both independently and collaboratively * Ability to identify issues and propose solutions * Medical writing experience in oncology, vaccines for infectious disease prevention and autoimmune diseases preferred
