Job Title: Principal Medical Writer
Location: United States (Remote)
About ICON plc:
ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. As a global leader in clinical development, ICON is committed to excellence, innovation, and nurturing high-performing talent across diverse teams. We are currently hiring a Principal Medical Writer to lead document development across clinical and regulatory functions.
Role Summary:
As a Principal Medical Writer, you will manage all aspects of medical writing, including authoring and reviewing clinical and regulatory documents. You will drive strategic content development, guide cross-functional collaboration, and ensure the clarity and scientific rigor of submissions to health authorities.
Key Responsibilities:
Manage and oversee medical writing functions, ensuring the timely and high-quality delivery of clinical and regulatory documentation.
Write and review documents such as clinical study reports, protocols, investigator brochures, and summary documents.
Contribute to the development of first-in-human oncology study protocols and other early-phase documents.
Lead document preparation, review statistical outputs, and integrate feedback from cross-functional stakeholders.
Utilize writing tools and platforms (e.g., PleaseReview, Documentum-based systems) to streamline the documentation process.
Serve as the lead writer across complex programs, coordinating multiple documents and study teams.
Ensure documents comply with applicable regulatory guidelines and company standards.
Qualifications:
Advanced degree in a scientific, clinical, or regulatory field preferred.
Minimum of 5 years’ experience in medical writing within the pharmaceutical or CRO industry, including lead writer responsibilities.
Immunology experience is advantageous but not required.
Demonstrated excellence in technical and scientific writing, with a strong ability to translate data for diverse audiences.
In-depth knowledge of regulatory documentation standards and submission requirements.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Excellent project management skills and the ability to prioritize multiple assignments.
Strong interpersonal and communication skills.
Must be legally authorized to work in the United States without sponsorship now or in the future.
Work Arrangement:
Full-time remote role (United States-based).
Compensation & Benefits:
Competitive salary and performance-based incentives.
Comprehensive health insurance options for individuals and families.
Competitive retirement planning programs to secure your financial future.
Global Employee Assistance Programme (TELUS Health), offering confidential 24/7 support for you and your dependents.
Life assurance and flexible benefits tailored to your location, such as:
Childcare vouchers
Bicycle purchase schemes
Discounted gym memberships
Health assessments
Subsidized transport options
Diversity & Inclusion:
At ICON, we embrace diversity and inclusion as core values. We provide an accessible, respectful, and harassment-free environment for all. All qualified candidates will be considered regardless of race, gender, disability, veteran status, or other protected attributes.
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