Senior Medical Writer (Manager or above) 部门:Clinical Development  工作类型:Full time, Employee
工作地点:Shanghai, China
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职位申请

Overview:

Compiles, writes, and edits medical/regulatory documents, and serves as a medical writer in cross-functional project teams with minimal supervision. Provides medical writing deliverables covering all phases of clinical research focusing on oncology.


Responsibilities:


  • Serve as medical writing lead for clinical trial-related clinical and regulatory documents.
  • Write/edit/review content of clinical trial-associated documents for new and ongoing programs.
  • Write, review, and/or edit publications (manuscripts, abstracts, slides/poster presentations, etc.)
  • 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, incorporates team comments, and lead discussions on document revision and finalization.
  • May manage outsourced writing/translation projects with minimal supervision.
  • Assist in the development and maintenance of SOPs and writing tools, such as templates and style manuals.
  • Perform QC checks on document content.
  • Mentor and train junior medical writing staff.


Qualification:


  • Master/PhD/MD in life sciences preferred; other relevant fields considered 3-5 years of regulatory and medical writing experience with clinical trial protocols, investigator's brochures, clinical study reports, safety narratives, other safety reports, 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