メディカルライティングマネージャー/ Medical Writing Manager

A renowned biopharmaceutical company is seeking a Medical Writing Manager. The chosen candidate will be ensuring high-quality regulatory and scientific documents for health agency interactions.

Responsibilities:

• Produce high-quality and on-time document deliverables
• Represent Japan Medical Writing as a subject matter expert in Japanese writing requirements and regulations
• Provide input and training on Japan-specific regulatory requirements to global teams
• Coordinate and update regulatory documents for submissions to Japan health authorities, including Clinical Trial Notifications and orphan drug designations
• Collaborate with local and global teams in preparing submissions
• Oversee relationships with CROs and Regulatory Affairs consultancies to ensure business objectives are met

Requirements:

• Bachelor’s degree or above in Life Science
• More than 2 years of experience as a medical writer in the sponsor or CRO setting
• Practical experience in writing multiple regulatory documents as an author
• Prior experience with regulatory submissions (briefing documents/CTA/CTN/NDA/MAA) and eCTD formatting
• Hands on experience in translating documents and building translation memories using machine and computer-assisted technology
• Experience using Trados or COTOHA/P is a plus
• In-depth knowledge of Good Clinical Practices, Japan regulations, ICH guidelines, and the drug development process
• Understanding of the drug development process
• Proficient in MS Office Suite (Trados Studio)
• Possess valid professional certification/credentials preferred
• Native level Japanese; business level English (TOEIC 850+)

About the Company:

This biotechnology company is dedicated to advancing RNA interference (RNAi) therapeutics, focused on treating genetically defined diseases. With a global presence, it is a recognised leader in the field of innovative healthcare solutions.

Keywords:

バイオ医薬品, 規制文書, 医療ライティング, 臨床8試験通知, 翻訳サービス, 求人, 外資系

2113970/001