募集要項
- 募集背景
- 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.
- 仕事内容
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A renowned biopharmaceutical company is seeking a Medical Writing Manager.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+)
- 応募資格
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- 必須
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More than 2 years of experience as a medical writer in the sponsor or CRO setting
- 歓迎
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Practical experience in writing multiple regulatory documents as an author
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY8,000,000.00 - JPY15,000,000.00 per annum
- 休日休暇
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完全週休2日制, 土日祝日休み, 有給休暇
