Job Title: Principal Medical Writer
Location: Remote, United States
Work Mode: Remote
Experience Required: Minimum 5 years in medical writing (oncology preferred)
Job ID: 2025-117948
Company: ICON plc – Strategic Solutions Division
Job Summary:
ICON plc is seeking a Principal Medical Writer to join our world-renowned clinical research organization. In this senior-level position, you’ll take ownership of medical writing deliverables across regulatory and clinical documentation, including protocols and study reports. Ideal for experienced professionals with a background in clinical trial documentation and regulatory writing, this is a fully remote role offering competitive benefits and the opportunity to shape high-impact, global studies.
Key Responsibilities:
Lead all aspects of medical writing for complex clinical programs.
Draft, edit, and finalize clinical study reports, protocols, IBs, and other regulatory documents.
Contribute to protocol development for first-in-human oncology studies.
Collaborate cross-functionally and manage review cycles using platforms like Documentum and PleaseReview.
Interpret clinical and statistical data, presenting it clearly for diverse audiences.
Serve as lead writer across multiple concurrent studies.
Ensure compliance with ICH-GCP, regulatory standards, and internal SOPs.
Required Skills & Qualifications:
Advanced degree in scientific, clinical, or regulatory field (preferred).
Minimum 5 years of experience in a lead medical writing role within pharma or CRO.
Oncology writing experience preferred.
Deep knowledge of regulatory writing standards and guidelines.
Strong command of MS Word, Excel, Outlook, and PowerPoint.
Excellent written and verbal communication skills.
Skilled in prioritizing and managing multiple concurrent projects.
Must be legally authorized to work in the United States without visa sponsorship.
Perks & Benefits:
Competitive salary
Generous annual leave
Comprehensive health insurance plans for individuals and families
Competitive retirement and savings programs
24/7 global Employee Assistance Programme via TELUS Health
Life insurance coverage
Optional country-specific benefits like gym discounts, childcare vouchers, travel subsidies, etc.
Diverse, inclusive workplace culture
Company Description:
ICON plc is a global leader in clinical research services, offering comprehensive development and commercialization solutions for the pharmaceutical, biotechnology, and medical device industries. With a focus on healthcare intelligence and data-driven innovation, ICON delivers results that improve patient outcomes and accelerate drug development worldwide.
Call to Action:
Are you ready to lead complex clinical documentation projects from anywhere in the US? Apply now to join ICON as a Principal Medical Writer and take your medical writing career to new heights.
Apply Today at: ICON Careers – Principal Medical Writer
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