Medical Writing Lead
Core
Lead author of regulatory and scientific documentation for China, managing content collection and vendor work to ensure compliance with ICH guidelines and local regulations.
Role type
Senior IC medical writing lead (regulatory)
Builds
Clinical regulatory documents (study reports, protocols, summaries), briefing books, and responses to regulatory agency questions.
Domain
Biopharmaceuticals / Clinical Development / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, regulatory document authoring, cross-functional coordination, vendor management, project management, ICH guidelines knowledge, GCP knowledge, strategic regulatory discussion, mentoring
Preferred skills
PhD in life science, experience with new product launch
Technologies
Authoring software
Responsibilities
Lead authoring of regulatory and scientific documentation, manage collection of content from cross-functional teams, manage work and deliverables of contract/vendor writers, coordinate cross-functional teams to produce high-quality documents, participate in preparation of responses to regulatory agency questions, mentor and manage junior writers or vendors
Seniority
Senior, hands-on IC with management responsibilities
