Medical Writer - Senior Medical Writer

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.

•3-5 years of regulatory and medical writing experience preferred, with clinical trial protocols, investigator’s brochures, clinical study reports, safety narratives, other safety reports, publication, 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.