📝 Shape Medical Communication: Senior Medical Writer - Japan (Office/Hybrid/Remote)
Join ICON plc as a Senior Medical Writer in Japan and become the scientific storyteller behind groundbreaking clinical research. This flexible role offers office, hybrid, or full remote options across Tokyo and Osaka, allowing you to craft compelling clinical narratives while contributing to Japan's healthcare innovation from your preferred work environment.
As a world-leading healthcare intelligence organization, we're seeking an experienced medical writer to lead the development of critical clinical documents and regulatory submissions. If you're passionate about scientific communication and excel at transforming complex data into clear, compliant narratives, this is your opportunity to advance your career while shaping medical writing standards in Japan's dynamic pharmaceutical landscape.
🎯 Your Medical Writing Mission: Key Responsibilities
Clinical Document Leadership
- Lead preparation, review, and editing of comprehensive clinical study documents including protocols, CSRs, IBs, and regulatory submissions (CTD modules)
- Ensure all documents demonstrate accuracy, clarity, and strict compliance with PMDA, ICH-GCP, and international regulatory standards
- Prepare clinical study protocols and comprehensive clinical study reports that meet scientific and regulatory requirements
- Develop and review Investigator's Brochures and Common Technical Document (CTD) clinical sections
Regulatory Excellence & Consultation
- Support regulatory agency interactions through document preparation, review, and strategic consulting
- Provide expert consultation on document development to ensure compliance with Japanese and global regulatory requirements
- Manage end-to-end regulatory document preparation and submission processes
- Stay current with evolving PMDA guidelines and international regulatory standards
Scientific Collaboration & Strategy
- Collaborate closely with cross-functional teams including clinical research, biostatistics, regulatory affairs, and medical affairs
- Interpret and analyze complex clinical trial data, summarizing scientific findings with precision and insight
- Contribute strategic scientific input to clinical development program planning and execution
- Support publication planning including abstracts, posters, and manuscripts for scientific dissemination
Team Mentorship & Development
- Mentor and coach junior medical writers on best practices, writing techniques, and scientific principles
- Foster a culture of excellence, collaboration, and continuous learning within the medical writing team
- Contribute to team growth through knowledge sharing and professional development guidance
- Lead by example in maintaining highest standards of medical writing quality
⭐ Your Profile: Medical Writing Expertise
Essential Qualifications
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (大学卒以上)
- 3-5 years minimum experience in medical writing within pharmaceutical, biotechnology, or CRO industry
- Comprehensive experience with clinical study protocols, CSRs, IBs, and CTD document preparation
- Business-level proficiency in both Japanese and English (written and spoken)
Technical Writing Competencies
- Proficiency in interpreting and summarizing complex clinical trial data and statistical analyses
- Excellent writing, editing, and proofreading skills with meticulous attention to detail
- Strong understanding of PMDA, ICH-GCP, FDA, and EMA regulatory requirements
- Experience with regulatory agency interactions and submission processes
Professional Attributes
- Exceptional Communication: Ability to communicate scientific concepts to diverse audiences
- Strategic Thinking: Capacity to provide scientific input to clinical development strategies
- Project Management: Ability to manage multiple projects in fast-paced, deadline-driven environment
- Collaborative Spirit: Effectiveness in working with cross-functional teams and stakeholders
Japan-Specific Expertise
- Experience with PMDA submission requirements and consultation processes
- Knowledge of Japanese clinical research environment and regulatory landscape
- Understanding of medical writing requirements for Japanese clinical trials
- Familiarity with Japan-specific document formats and submission processes
💫 Why Build Your Medical Writing Career at ICON Japan?
Impact Healthcare Innovation
- Play pivotal role in bringing new treatments to Japanese patients through compelling scientific documentation
- Work on diverse therapeutic areas and cutting-edge clinical research programs
- Contribute to Japan's growing role in global clinical development
- Ensure scientific integrity and regulatory compliance in medical communication
Flexible Work Options
- Choose from office-based (Tokyo/Osaka), hybrid, or 100% remote work arrangements
- Modern office facilities with collaborative workspaces where available
- Balance professional collaboration with personal work style preferences
- Technology infrastructure supporting seamless virtual collaboration
Professional Growth & Leadership
- Clear pathway to Principal Medical Writer and Medical Writing Leadership roles
- Exposure to global medical writing standards and best practices
- Opportunities for therapeutic area specialization and advanced training
- Leadership development through mentoring and team guidance responsibilities
Competitive ICON Japan Benefits
- Attractive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with Japanese language support
- Generous annual leave with Japanese public holidays
- Retirement planning benefits and financial security
- Professional development allowance and certification support
- Flexible benefits tailored to your lifestyle needs
✨ Ready to Craft Scientific Excellence?
If you're an experienced medical writer with expertise in Japanese regulatory requirements and passion for scientific communication, we encourage you to apply. This Senior Medical Writer role offers the unique opportunity to advance your career while shaping the future of clinical documentation in Japan's evolving healthcare landscape.
Apply Now and become ICON's next Medical Writing leader in Japan!
