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Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Beijing, China

Job Description:

• Lead and independently deliver complex CERs and related clinical evaluation documents.

• Develop and execute literature search strategies; conduct evidence synthesis, equivalence assessment, and risk analyses; and generate high‑quality clinical sections.

• Independently draft additional medical writing deliverables as assigned.

• Collaborate closely with RA, Clinical, and R&D teams to ensure timely achievement of project milestones.

• Support the preparation of regulatory responses and documentation for regulatory agency interactions.

• Contribute to the enhancement of SOPs, templates, and associated documentation standards, and assist in their implementation.

• Adhere to SOPs and documentation workflows to ensure timely, complete, and high‑quality project delivery.

• Provide guidance and oversight to specialists and new team members as needed.

 

 

Required Skills:

 

 

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)