Manager, Medical Writing – Japan

About the role

Johnson & Johnson Innovative Medicine is seeking a Manager, Medical Writing to lead the Japan Medical Writing function. This role is pivotal in developing clinical and regulatory documentation across therapeutic areas, ensuring high‑quality outcomes and strengthening internal capabilities.

Key responsibilities

• Write and coordinate clinical and regulatory documents, shaping content and scientific strategy.
• Serve as lead writer for compounds, submissions, indications, or disease areas and act as primary Medical Writing contact for cross‑functional teams.
• Lead cross‑functional document planning, review meetings, and establish timelines and strategies.
• Guide and train team members on Medical Writing processes and standards, and recommend process improvements.
• Coach junior writers, provide peer review, and represent Medical Writing in industry standards working groups.
• Manage internal medical writers, overseeing quality, compliance, performance, hiring, onboarding, reviews, and compensation planning.

Required profile

• University degree in a scientific field; advanced degree (Masters, PhD, MD) preferred.
• At least 8 years of pharmaceutical/scientific experience and 6 years of clinical/regulatory medical writing experience.
• 0–2 years of people‑management experience.
• Fluent Japanese and intermediate or higher English.
• Strong oral and written communication, attention to detail, and ability to lead in a team environment.

Required skills

• Medical Writing
• Regulatory Writing
• Clinical Documentation
• ICH guideline application