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東京都の臨床開発・薬事の求人196件応募資格・募集要項・仕事内容を見る
Manager, Japan Medical Writing, Regulatory Medical Writing, Global Development
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
Writes and coordinates clinical and regulatory medical writing documents across therapeutic areas, compounds, submissions, indications, and disease areas. Leads cross-functional document planning and review, supports team members through guidance and mentoring, and contributes to process improvements and functional strategy.
この求人に応募
応募資格
必須
- A university/college degree in a scientific discipline is required.
- At least 8 years of relevant pharmaceutical/scientific experience is required.
- At least 6 years of relevant clinical/regulatory medical writing experience is required.
- 0-2 years of people management experience if a people manager.
歓迎
- An advanced degree (eg, Masters, PhD, MD) is preferred.
Preferred Skills:
- Business Writing
- Clinical Research and Regulations
- Clinical Trials Operations
- Coaching
- Collaboration
- Copy Editing
- Data Synthesis
- Industry Analysis
- Medical Affairs
- Medical Communications
- Process Improvements
- Proofreading
- Quality Validation
- Standard Operating Procedure (SOP)
- Tactical Planning
- Technical Credibility
求める人物像
- Excellent oral and written communication skills.
- Attention to detail.
- Ability to lead in a team environment.
- Expert time management for self, direct reports (if applicable), and teams.
- Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
- Demonstrates learning agility.
- Builds and maintains solid and productive relationships with cross-functional team members.
募集要項最終確認 10/30
- 職種
- 臨床開発・薬事
- 雇用形態
- 記載なし
- 役職
- Manager
- 給与
- 記載なし
- 勤務地
- Chiyoda, Tokyo, Japan
- 働き方
- 記載なし
- 掲載日
- 2026/10/30 09:50(1日前)
- 最終確認
- 2026/10/30 21:51(1日前)
仕事内容
Position Summary:
- Able to write and coordinate basic and complex documents independently within and across therapeutic areas (TAs).
- Leads in a team environment and matrix.
- Able to function independently as a lead writer on any compound. May consult with more senior colleagues on complex situations.
- Leads discussions in or leads process working groups.
- May lead and actively participate in setting functional tactics/strategy.
- Initiates or provides input into TA-level strategy (eg, submission team, global program team, clinical team).
- Able to oversee the work of external contractors.
Principal Responsibilities:
- Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
- Leads or sets objectives for others on team projects and tasks, eg, leading process working groups or Communities of Practice.
- Guides or trains cross-functional team members on processes, best practices; coaches or mentors more junior writers.
- Able to function as a lead writer on any compound (or submissions, indications, or disease areas): is primary point of contact for medical writing activities for the cross-functional team (eg, clinical), with support as needed from more senior colleagues on complex situations with cross-functional teams.
- Leads cross-functional (eg, with clinical team) document planning and review meetings. Interacts with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
- Proactively provides recommendations for departmental process improvements.
- Completes all time reporting, training, and metrics database updates as required in relevant company systems.
- Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.
- May interact with senior cross-functional colleagues to strengthen coordination between departments.
- May represent medical writing in industry standards working groups.
Principal Relationships:
- Internal: Medical Writing leadership team, manager, other writers, cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in preparation and planning of clinical documents. Employees from other departments such as Human Resources, Finance, Information Technologies, Procurement, and Partnerships.
- External: May oversee day-to-day project-related work of contractors or external service providers as needed. May collaborate with external partner company staff on codeveloped compounds.
- Supervision (direct): Direct reports (if applicable), and others as assigned.
この求人は、ジョンソン・エンド・ジョンソン株式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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応募はジョンソン・エンド・ジョンソン株式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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