【1400～2000万円】メディカルライティング

【求人No NJB2354979】
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.

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