Medical Writer II
About the Role
Roles & Responsibilities:
• Prepare, write, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents
• Conduct literature reviews, analyze clinical trial data, and interpret results for scientific manuscripts, abstracts, posters, and presentations
• Review and validate clinical data for accuracy, completeness, and consistency with study protocols, SOPs, and regulatory requirements
• Collaborate with cross-functional teams, participate in project meetings, teleconferences, and client interactions
• Apply knowledge of regulatory guidelines, medical writing principles, and publication standards
• Keep updated with emerging trends, scientific developments, and regulatory updates in relevant therapeutic areas
Qualification:
• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field
Experience:
• Minimum 3 years of medical writing experience in pharmaceutical, biotechnology, or CRO industry
• Experience preparing clinical trial documents, regulatory submissions, and scientific publications
Skills:
• Strong scientific and medical terminology knowledge
• Excellent written and verbal communication skills
• Attention to detail and ability to convey complex information clearly
• Analytical and critical thinking skills for interpreting clinical data and identifying key findings
• Familiarity with Microsoft Office Suite, document management systems, and reference/statistical tools
About the Organization:
ICON plc is a global leader in healthcare intelligence and clinical research, providing innovative solutions and regulatory-compliant support to pharmaceutical, biotechnology, and medical device clients worldwide.
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