ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing medical science and improving patient outcomes. With a strong commitment to innovation, excellence, and inclusivity, ICON provides a dynamic work environment where professionals can grow and contribute to shaping the future of clinical development.
Job Description: Medical Writer I
Key Responsibilities
- Narrative Writing: Develop and write patient narratives for clinical study reports (CSRs) and related regulatory documents.
- Data Interpretation: Summarize and present clinical trial data accurately, ensuring compliance with ICH-GCP, FDA, and EMA guidelines.
- Collaboration: Work closely with clinical research teams, biostatisticians, and medical monitors to ensure high-quality deliverables.
- Compliance & Quality: Ensure all documents meet regulatory standards, company SOPs, and industry best practices.
- Editing & Review: Proofread and format documents for clarity, consistency, and compliance before CSR submission.
- Document Management: Maintain version-controlled files and track progress to meet deadlines efficiently.
Qualifications & Skills
- Education: Master’s degree in Life Sciences, Pharmacy, or related field (MSc, PhD preferred).
- Experience: 2-3 years in medical writing, specifically in CSRs, regulatory documents, and patient narratives.
- Technical Skills: Proficiency in Microsoft Office (Word, Excel, PowerPoint) and reference management software.
- Soft Skills:
- Excellent written and verbal communication.
- Ability to interpret complex clinical data and present it clearly.
- Strong attention to detail and time management.
Preferred Qualifications
- Experience in writing clinical trial protocols, submission documents, or patient narratives.
- Familiarity with electronic document management systems (eDMS).
Why Join ICON plc?
ICON offers a supportive, inclusive, and high-performing work culture with competitive benefits, including:
✅ Flexible work options (Hybrid/Remote)
✅ Competitive salary & performance bonuses
✅ Health insurance & wellness programs
✅ Retirement planning & life assurance
✅ Global Employee Assistance Program (EAP)
✅ Paid leave & work-life balance initiatives
✅ Country-specific perks (gym discounts, childcare vouchers, travel passes, etc.)
