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About the Role
Our Medical Writing team prepares regulatory documents to deliver new medicines and expanded indications to patients as quickly as possible. We work closely with our overseas colleagues to create clear and efficient documentation, contributing to the prevention of significant drug lag compared with other countries.
Responsibilities
- Writes or coordinates clinical and regulatory documents such as, but not limited to, CSRs, protocols, summary documents, regulatory responses, and briefing documents.
- Leads cross-functional 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.
- Completes all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
- Able to function as a lead writer on most compounds under supervision.
- Is primary point of contact for medical writing activities for the cross-functional team.
- Coaches or mentors more junior staff on document planning, processes, and content.
- Provides peer review as needed.
- Actively participates in or leads process working groups.
Requirements
- At least 6 years of relevant pharmaceutical/scientific experience is required.
- At least 4 years of relevant clinical/regulatory medical writing experience is required.
- Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision.
- Excellent oral and written communication skills.
- Attention to detail.
- Ability to function in a team environment.
- Organizes time well.
- Strong leadership skills, both in project and process management as well as in time management.
- Resolves complex problems under supervision.
- Demonstrates learning agility.
- Builds solid and productive relationships with cross-functional team members.
- Fluent Japanese, intermediate or higher English skill is requirement.
- Domestic business trips are sometimes limited to the Tokyo metropolitan area, and overseas travel is infrequent.
Skills
- Business Writing
- Clinical Research and Regulations
- Clinical Trials Operations
- Coaching
- Collaboration
- Communication
- Copy Editing
- Data Synthesis
- Industry Analysis
- Medical Affairs
- Medical Communications
- Problem Solving
- Process Oriented
- Proofreading
- Quality Standards
- Research Ethics
- Standard Operating Procedure (SOP)
Location
- Chiyoda, Tokyo, Japan
Work Type
- Full-time
Experience Level
- Experienced Medical Writer
- Medical Writer III (P6)
Education Level
- University/college degree in a scientific discipline
- Advanced degree (Masters, PhD, MD) is preferred
About the Company
- 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.
Equal Opportunity
- 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.