Medical Writing Manager

Job Scope

Contribute 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 Biogen programs.

Key Responsibilities:

• Lead 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.

Essential Skills and Qualifications Required:

• Strong experience in writing and reviewing clinical, nonclinical, and regulatory documents (e.g., protocols, investigator’s brochures, CSRs, briefing documents, CTDs).
• Demonstrated leadership skills to plan, coordinate, and drive document development.
• Ability to build effective teams that bring diverse opinions and perspectives.
• Broad understanding of clinical development beyond medical writing, enabling contributions to Japan regulatory strategy.
• Strong writing proficiency in both English and Japanese.
• Proficiency with MS Word (including style templates), Adobe Acrobat, and Documentum‑based electronic document management systems.
• Strong communication, problem‑solving, and time‑management skills in both English and Japanese.
• Experience in vendor management.
• A proactive workstyle that incorporates emerging technologies, including generative AI.

Education

• Life Science degree

Experience Requirements:

• 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.

 

Job Level: Management