Medical Writing Lead

About the role

The Lead, Medical Writing works with the global medical writing team and China CPT to create medical writing deliverables for China, ensuring clinical and regulatory documents are high quality, timely and compliant with internal and external standards. This is a management-level position based in Beijing.

Key responsibilities

• Act as lead author of regulatory and scientific documentation and manage content collected from cross-functional teams in line with ICH guidelines, company SOPs and local regulations.
• Take part in strategic regulatory discussions throughout drug development with China Reg Leads and/or CPT.
• Serve as the main medical writing contact for China with the global function and manage China-based contract or vendor writers as needed.
• Ensure clinical regulatory documents (study reports, protocols, summaries, responses to regulators, submission documents) present clinical messages accurately and consistently from concept through licensing and disclosure.
• Write briefing books and other strategic regulatory documents such as BTD requests, help prepare responses to regulator questions and support presentation materials for agency meetings.
• Work independently to coordinate cross-functional teams and keep abreast of industry standards, regulatory requirements and departmental guidelines.

Required profile

• Master's degree in a life science discipline (PhD preferred).
• 7-10 years of medical writing experience in global drug development, including submission, approval and launch of new products.
• Excellent verbal and written English and strong communication skills.
• Able to work in a multicultural environment, mentor and manage vendors or junior writers, and influence cross-functionally to stay compliant and improve quality and efficiency.

Required skills

• Familiarity with GCP and ICH guidelines.
• Project management skills and attention to detail.
• Technical skills with relevant authoring software.
• Flexibility and judgment when priorities change during projects.