シニアメディカルライター（Sr. Medical Writer/ IQVIA Services）
IQVIA · Tokyo, Japan +1 more
Medical AffairsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
IQVIA seeks a senior medical writer to lead development of clinical trial documents, regulatory submissions, and research reports. The role involves managing projects, reviewing team work, and supporting diverse pharmaceutical and medical device programs across therapeutic areas.
What they're looking for
- 5+ years medical writing experience, excluding translation-only work
- Bachelor's or master's degree in science-related field
- Comprehensive knowledge of drug development, GCP, and ICH guidelines
- Domestic pharmaceutical regulatory affairs knowledge required
- Foundational knowledge in pharmaceutics, medicine, and statistics
- English proficiency: reading, writing, document review, translation (TOEIC 730+)
- Fluent Japanese language skills
What you'll be doing
- Create and review clinical trial documents including protocols and CTD submissions
- Adapt global trial protocols to meet Japanese regulatory requirements
- Prepare clinical research and post-marketing surveillance documentation
- Manage project timelines, staffing, budgets, and client communication
- Mentor and supervise junior medical writing staff
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.