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About the Role
As the world’s largest FSP organisation, with over 90 sponsor partnerships, ICON offers stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. As a Senior Medical Writer at ICON, you will lead the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.
Responsibilities
- Lead the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity.
- Collaborate closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, and summarize scientific findings.
- Participate in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.
- Contribute to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences.
- Mentor and coach junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.
- Prepare clinical study protocols.
- Prepare clinical study reports.
- Prepare regulatory submission documents (CTD: Common Technical Document) (non-clinical or clinical parts).
- Prepare investigator brochures.
- Review prepared documents.
- Handle regulatory affairs (e.g., clinical document creation, review, or consulting).
- Consult on all aspects of regulatory-compliant document creation.
- Provide appropriate guidance to less experienced members and contribute to their growth.
Requirements
- Bachelor's degree in a relevant scientific discipline or healthcare-related field.
- Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses.
- Excellent writing, editing, and proofreading skills.
- Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications.
- Experience in interacting with regulatory agencies during the review and approval process.
- Demonstrated ability to work effectively in a fast-paced, deadline-driven environment.
- Ability to manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables.
- Excellent interpersonal and communication skills.
- Ability to collaborate effectively with cross-functional teams.
- Ability to build relationships with key stakeholders and influence decision-making processes.
- University degree or equivalent in fields such as medicine, veterinary medicine, agriculture, or life sciences.
- Minimum of 3 years of medical writing experience in a pharmaceutical company or CRO.
- Business-level English proficiency.
- Must have the legal right to work in the country where the role is based.
Skills
- Medical writing
- Clinical research
- Data interpretation
- Scientific writing
- Regulatory affairs
- ICH-GCP
- FDA
- EMA
- Project management
- Interpersonal communication
- Stakeholder management
- Decision-making influence
Location
- Tokyo
- Osaka
- Remote Office Hybrid
Work Type
- Hybrid
Experience Level
- Senior
- 3+ years
Education Level
- Bachelor's degree
- University degree
Benefits
- Competitive base salary
- Performance related incentives
- Health and wellbeing programmes
- Medical coverage
- Dental coverage
- Vision coverage
- Retirement plans
- Pension plans
- Life assurance
- Disability coverage
- Employee assistance programmes
- Wellbeing resources
- Learning and development opportunities
- Structured training
- Career pathways
About the Company
- At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
- As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
Equal Opportunity
- ICON is an equal opportunity employer.
- We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
- If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.