Medical Writer III – Regulatory & Clinical Documents

About the role

Johnson & Johnson Innovative Medicine seeks an experienced Medical Writer III to join its Medical Writing team in Chiyoda, Tokyo. The role focuses on preparing regulatory and clinical documents to accelerate the delivery of new medicines to patients.

Key responsibilities

• Write and coordinate clinical and regulatory documents such as CSRs, protocols, summary documents, regulatory responses, and briefing documents.
• Lead cross‑functional document planning and review meetings, interacting with clinical and other teams.
• Establish document timelines and strategies, ensuring alignment with internal processes.
• Serve as primary point of contact for medical writing activities for cross‑functional teams.
• Coach and mentor junior staff, provide peer reviews, and participate in process working groups.

Required profile

• University degree in a scientific discipline; advanced degree (Masters, PhD, MD) preferred.
• Minimum 6 years of pharmaceutical/scientific experience, including at least 4 years of clinical/regulatory medical writing.
• Fluent Japanese and intermediate or higher English.

Required skills

• Medical writing for regulatory and clinical submissions.
• Interpretation and presentation of statistical and medical information.