Medical Writer II
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Job Description
Medical Writer developing clinical trial documents, regulatory submissions, and scientific publications for ICON, a global healthcare research organization. Supporting clinical data interpretation and cross-functional study teams.
Responsibilities:
- Develop and prepare clinical trial documents, regulatory submissions, and scientific publications
- Take responsibility for medical writing deliverables, ensuring quality and efficiency
- Collaborate with cross-functional teams to prepare, write, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), and patient narratives
- Conduct literature reviews, data analysis, and interpretation of clinical trial results to support scientific manuscripts, abstracts, and posters
- Assist in reviewing and validating clinical data for accuracy, completeness, and consistency with study protocols, SOPs, and regulatory requirements
- Participate in project meetings, teleconferences, and client interactions to discuss objectives, timelines, and deliverables
- Provide input and feedback on document content, format, and presentation
- Keep abreast of emerging trends, scientific developments, and regulatory updates in relevant therapeutic areas
Requirements:
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field
- Minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry
- Proficiency in scientific and medical terminology
- Excellent written and verbal communication skills
- Attention to detail
- Ability to convey complex information in a clear and concise manner
- Strong analytical and critical thinking skills
- Ability to review and interpret clinical data, identify key findings and trends, and communicate results effectively to diverse stakeholders
- Familiarity with regulatory requirements, industry guidelines, and publication standards governing clinical trial documents and scientific manuscripts
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Familiarity with document management systems, reference management software, and statistical analysis tools preferred
- Legal right to work in Japan
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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