Medical Writer II
ICON plc
full-time
Posted on:
Location Type: Hybrid
Location: Warsaw • 🇵🇱 Poland
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Collaborating with cross-functional teams to prepare, write, and edit clinical study reports (CSRs)
- Clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents in compliance with internal standards and regulatory guidelines.
- Conducting literature reviews, data analysis, and interpretation of clinical trial results to support the development of scientific manuscripts, abstracts, posters, and presentations for publication in peer-reviewed journals and scientific conferences.
- Assisting in the review and validation of clinical data, ensuring accuracy, completeness, and consistency with study protocols, standard operating procedures (SOPs), and regulatory requirements.
- Participating in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, and deliverables.
- Keeping 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
- Familiarity with regulatory requirements, industry guidelines, and publication standards governing the preparation and submission of clinical trial documents and scientific manuscripts.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingdata analysisliterature reviewsclinical trial results interpretationscientific manuscripts preparationregulatory document complianceattention to detailanalytical skillscritical thinking
Soft skills
written communicationverbal communicationability to convey complex informationcollaborationproject management