[Innovative Medicine] R&D, Manager, Japan Medical Writing, Regulatory Medical Writing, Global Development
Johnson & Johnson Innovative Medicine · JP
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About the Role
Johnson & Johnson is dedicated to improving global health through healthcare innovation. This role involves writing and coordinating complex medical and regulatory documents, leading teams, and contributing to strategic planning within therapeutic areas.
Responsibilities
- Write and coordinate basic and complex documents independently within and across therapeutic areas.
- Lead in a team environment and matrix.
- Function independently as a lead writer on any compound, consulting with senior colleagues on complex situations.
- Lead discussions or process working groups.
- Lead and actively participate in setting functional tactics/strategy.
- Initiate or provide input into TA-level strategy.
- Oversee the work of external contractors.
- Write or coordinate all types of clinical and regulatory documents, taking a proactive or lead role in content and scientific strategy.
- Lead or set objectives for others on team projects and tasks.
- Guide or train cross-functional team members on processes and best practices; coach or mentor more junior writers.
- Function as a lead writer on any compound, submission, indication, or disease area.
- Serve as the primary point of contact for medical writing activities for the cross-functional team.
- Lead cross-functional document planning and review meetings.
- Interact with cross-functional colleagues on document content and champion MW processes and best practices.
- Establish document timelines and strategies in accordance with internal processes.
- Proactively provide recommendations for departmental process improvements.
- Complete all time reporting, training, and metrics database updates.
- Coach or mentor more junior staff on document planning, processes, content, and provide peer review.
- Interact with senior cross-functional colleagues to strengthen coordination between departments.
- Represent medical writing in industry standards working groups.
Requirements
- 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.
- Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
- Resolves majority of problems independently.
- May consult with senior colleagues on higher complexity situations.
- May interact with senior cross-functional colleagues often requiring coordination across multiple functions and groups to resolve issues.
- 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.
- Solid knowledge and application of regulatory guidance documents such as ICH requirements.
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
Location
- Chiyoda, Tokyo, Japan
- Chiyoda-ku, Tokyo, Japan
Work Type
- Full-time
Experience Level
- 8+ years pharmaceutical/scientific experience
- 6+ years clinical/regulatory medical writing experience
- 0-2 years people management experience (if applicable)
Education Level
- University/college degree in a scientific discipline required
- Advanced degree (Masters, PhD, MD) 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.
- 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.