[Innovative Medicine] R&D, Manager Medical Writing, Japan Medical Writing, Regulatory Medical Writin

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Job Function:
Medical Affairs Group

Job Sub Function:
Medical Writing

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Manager, Medical Writing, located in Japan.

Japan Medical Writing plays a critical role in advancing the portfolio in Japan by providing leadership in the development of clinical and regulatory documentation across therapeutic areas.

The function drives excellence in both document delivery and people leadership, ensuring high-quality outcomes, shaping content strategies and tactical execution, influencing functional and therapeutic-area priorities, and strengthening internal medical writing capabilities to support successful portfolio execution in Japan.

Key Responsibilities:


* Write or coordinate clinical and regulatory documents, taking a proactive or lead role in content and scientific strategy.


* Serve as lead writer for compounds, submissions, indications, or disease areas and act as the primary Medical Writing contact for cross-functional teams.

Lead cross-functional document planning and review meetings, and establish document timelines and strategies in accordance with internal processes.


* Lead or set objectives for team projects, process working groups, and Communities of Practice.

Guide or train cross-functional team members on Medical Writing processes and standards.

Proactively recommend departmental process improvements.


* Coach or mentor junior writers on document planning, processes, and content, and provide peer review as needed.


* Interact with senior cross-functional colleagues to strengthen coordination between departments.


* Represent Medical Writing in industry standards working groups and coordinates project-related work of contractors or external service providers, as appropriate.


* Lead internal medical writers, including accountability for quality, compliance, objectives, performance oversight, development, assignments, adherence to policies, hiring, onboarding, reviews, and compensation planning.

Qualifications

Education:


* A university/college de...