🚀 Shape Clinical Narratives: Senior Medical Writer (Tokyo/Osaka | Hybrid/Remote)
Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as a Senior Medical Writer in Japan. This is a pivotal role where your scientific expertise and narrative skill will directly shape the documentation that drives regulatory approvals and communicates breakthrough clinical science to the world. Enjoy the flexibility of a hybrid or full remote working model, anchored to our Tokyo or Osaka offices.
We are seeking an accomplished medical writing professional to lead the development of critical clinical and regulatory documents. If you possess a deep understanding of clinical development, excel at transforming complex data into clear and compelling narratives, and are passionate about mentoring others, this is your opportunity to advance your career while contributing to the future of medicine in Japan and globally.
🎯 Your Medical Writing Mission: Key Responsibilities
Strategic Document Development & Leadership
- Lead the authoring, review, and finalization of high-quality, submission-ready clinical documents, including:
- Clinical Study Protocols (治験実施計画書)
- Clinical Study Reports (CSRs / 治験総括報告書)
- Investigator's Brochures (IBs / 治験薬概要書)
- Clinical sections for CTD (Common Technical Document) submissions (医薬品の承認申請資料)
- Provide strategic writing expertise across all phases of clinical development, from protocol design to regulatory submission.
Scientific Analysis & Regulatory Excellence
- Interpret and summarize complex clinical trial data and statistical analyses, ensuring scientific accuracy and clarity.
- Ensure all documents comply with ICH-GCP, PMDA, FDA, EMA, and other relevant regulatory guidelines and internal standards.
- Support regulatory agency interactions by preparing concise, accurate responses to queries and contributing to consultation meetings (当局対応).
Cross-Functional Collaboration & Influence
- Serve as the medical writing lead on project teams, collaborating closely with Clinical Science, Biostatistics, Regulatory Affairs, and Safety.
- Facilitate document review cycles, strategically incorporate team input, and drive consensus to meet aggressive timelines.
- Provide expert consulting on document strategy, content, and processes to ensure regulatory success.
Knowledge Sharing & Mentorship
- Mentor and coach junior medical writers, fostering their scientific, writing, and project management skills (経験の浅いメンバーへの指導).
- Contribute to the development of best practices, templates, and training materials within the medical writing department.
Publication & Dissemination Support
- Contribute to the development of manuscripts, abstracts, and posters for publication in peer-reviewed journals and presentation at scientific conferences.
⭐ Your Profile: Senior Medical Writer Expertise
Essential Qualifications
- Advanced degree (Master's, PhD, PharmD, or MD) in Life Sciences, Pharmacy, Medicine, or a related field.
- Minimum of 3-5 years of dedicated medical writing experience within the pharmaceutical, biotechnology, or CRO industry.
- Proven hands-on experience authoring key submission documents (Protocols, CSRs, IBs, CTD clinical summaries).
- Full professional proficiency in both Japanese and English is mandatory for drafting, reviewing, and consulting on documents for the Japan market and global teams.
Required Knowledge & Skills
- In-depth Clinical Development Knowledge: Comprehensive understanding of the clinical development process from protocol design through to regulatory submission.
- Regulatory Mastery: Strong knowledge of ICH guidelines, GCP, and specific requirements of the PMDA, FDA, and EMA.
- Scientific Communication Excellence: Exceptional scientific writing, editing, and data interpretation skills with meticulous attention to detail.
- Project Leadership: Demonstrated ability to manage multiple complex writing projects independently, prioritizing effectively in a fast-paced, deadline-driven environment.
Professional Attributes
- Strategic Thinker: Ability to provide strategic input on document content and development plans.
- Collaborative Influencer: Excellent interpersonal skills to build relationships, manage stakeholders, and guide cross-functional teams.
- Proactive Mentor: A commitment to fostering team growth and sharing knowledge within a collaborative environment.
💫 Why Build Your Medical Writing Career at ICON in Japan?
Impact Drug Development in Japan & Globally
- Author the definitive documents that form the backbone of regulatory submissions, directly influencing patient access to new therapies.
- Work on cutting-edge therapeutic areas and be a key scientific voice within a global industry leader.
Career Growth & Leadership
- Clear pathway to Principal Medical Writer and functional leadership roles.
- Opportunities to specialize in specific therapeutic areas or lead writing for complex, high-profile programs.
- Continuous professional development through formal training and mentorship.
Unparalleled Flexibility & Support
- Hybrid/Full Remote Model: Work with flexibility from your preferred location, connected to our supportive Tokyo/Osaka hubs.
- Global Network: Collaborate with a worldwide community of medical writing and development experts.
- Inclusive Culture: Join a diverse and dynamic team that values excellence, innovation, and work-life balance.
Competitive ICON Benefits in Japan
- Attractive, performance-oriented compensation package.
- Comprehensive health, dental, and life insurance plans for you and your family.
- Generous annual leave entitlement.
- Competitive retirement savings plan.
- Global Employee Assistance Programme (EAP) providing 24/7 support.
- Flexible benefits options tailored to support your lifestyle and well-being.
✨ Ready to Author the Future of Medicine in Japan?
If you are a strategic, bilingual medical writer with a passion for scientific excellence and a drive to mentor the next generation, we encourage you to apply. This Senior Medical Writer role offers a unique opportunity to shape clinical narratives with flexibility, impact regulatory success, and grow your career with a global leader.
Apply Now and become the scientific storytelling expert who turns clinical data into compelling evidence for approval.
