メディカル・バイオ - 臨床開発メディカルライター

The Medical Writer (Director-level) will lead the development of Japan-specific regulatory documents required for submissions to Japanese regulatory authorities (PMDA/MHLW), including CTD modules, consultation briefing documents, and responses to PMDA inquiries.

This role is highly hands-on, requiring deep scientific understanding, strong regulatory writing expertise, and close coordination with both Japan-based and global stakeholders.

The incumbent will serve as the primary Medical Writing point of contact in Japan, ensuring alignment with Global Medical Writing and Trial Transparency & Disclosure (TT&D), while applying advanced knowledge of ICH, including ICH M4, and PMDA regulatory requirements, to produce high-quality and compliant documentation.

Although the direct reporting line for this role is to the Head of Clinical Development Japan, the position will also maintain a dotted-line functional relationship with the Global Head of Medical Writing to ensure scientific alignment, adherence to global standards, and consistency in document quality across regions.

■休日：完全週休二日制, 土, 日, 祝日

10年以上のメディカルライティング業務
英語ビジネスレベル

■職種未経験者：不可