RA Strategic Medical Writer
Core
Lead Japan-specific regulatory and clinical document preparation for pharmaceutical submissions, acting as a local coordinator between the Japan project team and global stakeholders.
Role type
Senior Strategic Medical Writer (Regulatory)
Builds
Regulatory submissions (s)NDA, briefing books, request forms, and package inserts for Japan markets.
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Medical writing, Regulatory affairs, Project management, Vendor management, Cross-functional collaboration, Quality control (QC), Document structure planning
Preferred skills
Master's or PhD/MD degree, Microsoft Office and Adobe Acrobat proficiency
Technologies
Electronic document management systems
Responsibilities
Prepare Japan-specific regulatory and clinical documents (briefing books, request forms, package inserts), manage project timelines and cross-functional inputs, liaise with medical writing vendors, ensure quality control of deliverables, represent the team in meetings.
Seniority
Senior, hands-on IC