RA Strategic Medical Writer

📋 Description

• Prepare high-quality and accurate Japan-specific regulatory and clinical documents in accordance
• Provide project management for all projects for assigned team.
• Serve as local coordinator to streamline the communication between Japan project team and all
• Liaison activities with medical writing vendor in Japan as needed regarding preparation of
• Provide effective leadership of assigned work to support smooth progress of each project in
• Prepare briefing books including those for PMDA consultation/pre-meeting, request forms, responses

🎯 Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or other related academic area or
• Master’s or PhD/MD degree is preferred.
• At least 5 years’ experience in or equivalent skill for clinical development, regulatory affairs
• Ability to communicate clinical data succinctly, clearly, and accurately in writing.
• Good team player and good planner with proactive, accountable, and details-oriented mindset.
• Must have excellent fluency in both oral and written communication skills in both Japanese and