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東京都の臨床開発・薬事の求人187件応募資格・募集要項・仕事内容を見る
RA Strategic Medical Writer
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 正社員
どんな仕事かAIによる生成
The RA Strategic Medical Writer prepares Japan-specific regulatory and clinical documents and manages projects for the assigned team. The role coordinates communication between Japan project teams, global stakeholders, and medical writing vendors, and supports document quality control and review.
この求人に応募
応募資格
必須
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or other related academic area or equivalent ability is required. Master’s or PhD/MD degree is preferred.
- At least 5 years’ experience in or equivalent skill for clinical development, regulatory affairs, post-marketing surveillance including at least 2 years’ experience in medical writing.
- Ability to communicate clinical data succinctly, clearly, and accurately in writing.
- Must have excellent fluency in both oral and written communication skills in both Japanese and English.
- Excellent skill for operating Microsoft Office (Word, Excel) and Adobe Acrobat is preferred.
求める人物像
- A good team player and good planner with proactive, accountable, and details-oriented mindset
募集要項最終確認 10/28
- 職種
- 臨床開発・薬事
- 雇用形態
- Full-time
- 給与
- 記載なし
- 勤務地
- Minato City, Tokyo
- 働き方
- 記載なし
- 経験年数
- 5年以上
- 学歴
- 大学卒業以上
- 掲載日
- 2026/10/14 02:52（15日前）
- 最終確認
- 2026/10/28 19:10（1日前）
仕事内容
Purpose Statement:
- Prepare high-quality and accurate Japan-specific regulatory and clinical documents in accordance with regulatory requirements based on policies of Global R&D including Global SMW, and Japan Development.
- Provide project management for all projects for assigned team.
- Serve as local coordinator to streamline the communication between Japan project team and all global stakeholders including global medical writing team (Strategic Medical Writing [SMW]).
- Liaison activities with medical writing vendor in Japan as needed regarding preparation of regulatory and clinical documents.
Major Responsibilities:
- Provide effective leadership of assigned work to support smooth progress of each project in accordance with pharmaceutical regulations, SOPs, manuals, etc. Primary remit includes but is not limited to:
- Briefing books including those for PMDA consultation/pre-meeting
- Request form for PMDA consultation/premeeting
- Responses to PMDA/MHLW for (s)NDA, PMDA consultation, and CTN, including being part of the Rapid Response Team (RRT)/Labeling Subteam (LST) Responses to Agency Questions including ad hoc requests including those for PMDA consultation/premeeting documentation
- J-CTD Module 1 to include Japan package insert
- Japan s(NDA) application form
- Orphan Drug Designation request form, briefing book, application form
- Sakigake Designation request form, briefing book, application form
- Specific Use designation request form, briefing book, application form
- Japan Package Insert Maintenance, including update of side effect sections, assessment description based on CCDS revision
- Japan CTD updates during (s)NDA
- Post-submission safety updates
- Advise on the document structure and content based on medical writing industry best practices and experience in medical writing.
- Formulate assignment plan and timeline for responsible cross-functional team members to each project, collecting the inputs from Japan project team and managing the project to completion.
- Build cooperative relationships with all cross-functional stakeholders both local and global (Global R&D, Development TA, Data & Statistical Sciences, Global Regulatory Strategy, Global SMW, Clinical Sciences, Japan Project Team, TAG, JDSSG, vendors)
- etc.) and effectively represent SMW at assigned meetings, as necessary.
- Prepare/update appropriate procedures when using a medical writing vendor.
- Ensure that appropriate quality control (QC) checks are performed on medical writing deliverables, as required. Ensure authoring and review with the electronic document management system.
この求人は、アッヴィ合同会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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応募はアッヴィ合同会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。
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