Medical Writing Specialist
SERVIER MONDE · Tokyo
Job description
About the role
The Medical Writing Specialist will contribute to the simultaneous development and submission of Servier’s new drugs across the US, EU, and Japan through high‑quality medical writing activities.
Key responsibilities
- Prepare high‑quality new drug applications, including domestic CTD clinical modules and responses to PMDA/MHLW inquiries.
- Develop consultation materials for PMDA/MHLW and handle their inquiries.
- Communicate and collaborate with internal departments, headquarters, domestic CROs and other contractors via email and online or face‑to‑face meetings.
Required profile
- Advanced degree (Bachelor’s or higher) in Medicine, Pharmacy, or Life‑Science field.
- Strong attention to detail and ability to work cross‑functionally.
- Proficiency in Japanese writing and ability to read and communicate verbally in English.
Required skills
- Medical writing experience in a pharmaceutical company, CRO, or research institution.
- Hands‑on experience preparing domestic CTD clinical modules referencing global CTDs, international literature, and latest ICH guidelines.
- Experience with NDA submissions in Registration Category 1‑4.
- English‑to‑Japanese translation capability.
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SERVIER MONDE
Tokyo