Job Details
Posted 19 September, 2026
Job Id: 630677
Principal Medical Writer – Japan
Job Description
Principal Medical Writer
Japan | Regulatory Affairs & Medical Writing
A global biopharmaceutical organisation is seeking a Principal Medical Writer to lead the development of high-impact regulatory and clinical documents supporting Japanese and global drug development programs.
Key Responsibilities
- Lead authoring of regulatory submission documents including Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures and CTD modules.
- Drive medical writing strategy and ensure consistent submission messaging across programmes.
- Lead responses to health authority queries and support regulatory interactions throughout the approval process.
- Provide medical writing expertise for multi-regional clinical trials, ensuring alignment between global and local requirements.
- Support inspection readiness activities and contribute to regulatory compliance initiatives.
- Collaborate with cross-functional global teams and provide oversight of scientific content and document quality.
Requirements
- Bachelor’s degree in Life Sciences or related field; advanced degree (MS, PharmD or PhD) preferred.
- 7+ years of medical writing experience within pharmaceutical, biotech or CRO environments.
- Strong experience supporting regulatory submissions and health authority interactions in Japan.
- Deep knowledge of GCP, ICH guidelines and clinical development processes.
- Excellent stakeholder management and cross-functional collaboration skills.
- Fluent Japanese and professional-level English communication skills.
Ideal Background
- Senior Medical Writer, Principal Medical Writer, Regulatory Medical Writer or Scientific Writing Lead.
- Experience supporting NDA/BLA submissions, global clinical development programs, and regulatory agency interactions.
- Background in pharmaceutical, biotechnology or CRO settings with exposure to both local Japanese and global studies.
Opportunity Join a globally focused development team and play a strategic role in bringing innovative therapies to market, leading critical regulatory documents and influencing submission success across Japan and international markets.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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