medical writing manager.

■Job ScopeContribute as a medical writer with primary expertise in clinical documentation, while also supporting nonclinical sections as needed. This role leads and supports the development of regulatory documents—including CTD modules and briefing documents—and actively participates in strategic regulatory discussions throughout the drug development process, from early development to J‑NDA submission and approval for programs.■Key ResponsibilitiesLead the preparation of CTD Module 2 (clinical sections), Module 5, and relevant parts of Module 1.Lead the preparation of briefing documents (BDs) for PMDA consultations, both informal and formal.Contribute to drafting response documents for PMDA inquiries during the approval review process and consultations.Support lead nonclinical writers in preparing documents such as CTDs, BDs, and PMDA response documents.Collaborate closely with global teams to obtain necessary information and cross‑functional support.Manage external vendors for document development, including translation and editorial services.

求められる経験
Approximately 5 years of clinical medical writing experience in global drug development, including new drug application, approval, and launch.
Approximately 3 years of nonclinical writing experience in global drug development is preferred.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収800 ～ 1,400万円

賞与
‐
雇用期間
期間の定めなし