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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

Experience and Skills:

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 is required.

Preferred:

• Recognizes how to best interpret, summarize, and present statistical and medical information clearly and accurately in complex document types.
• Resolves majority of problems independently. May consult senior colleagues across multiple functions and groups on higher complexity situations to resolve issues.
• Excellent oral and written communication skills, attention to detail, and ability to lead in a team environment.
• Expert time management for self, teams, and direct reports, with strong leadership skills in project management, process management, influencing, negotiating, assertiveness, and taking initiative. Demonstrates learning agility.
• Build and maintain solid, productive relationships with cross-functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements. Lead direct report goal-setting, performance evaluations and ratings, promotions, and salary adjustment discussions in close interaction with functional leadership.

Other:

• Fluent Japanese and intermediate or higher English skills are required.
• Domestic business trips may be required, primarily within the Tokyo metropolitan area; overseas travel is infrequent.
• For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

＜For Internal Applicants＞

• Based on your experience and interview evaluation, the position title and level may vary.
• If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.
• For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.

 

 

Required Skills:

 

 

Preferred Skills:

Analytics Insights, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Copy Editing, Cross-Functional Collaboration, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medical Affairs, Medical Communications, Performance Measurement, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Team Management