Job Title: Senior 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. We are committed to driving innovation and building an inclusive culture focused on high performance and excellence. We are currently seeking a Senior Medical Writer to support the preparation of high-quality, scientifically grounded documents for regulatory submission.
Role Summary:
As a Senior Medical Writer, you will prepare, write, edit, and review regulatory documents to ensure they are scientifically accurate and compliant with regulatory standards. You will work collaboratively with cross-functional teams and play a key role in regulatory submission efforts, aligning with project timelines and quality expectations.
Key Responsibilities:
Draft, revise, and finalize high-quality clinical and regulatory documents including protocols, Investigator Brochures (IBs), and clinical study reports (CSRs).
Serve as the Regulatory Scientific Writing (RSW) representative on cross-functional teams including Clinical, Pharmacovigilance, CPPM, and others.
Interpret complex scientific data and transform it into clear, structured content for health authority submissions.
Collaborate with team members on project planning, milestones, and strategic document content.
Coordinate document review, quality control (QC), approval processes, and resolve content issues during document development.
Assist in arranging and conducting team review meetings and providing project updates to RSW leadership.
Ensure regulatory documentation aligns with ICH, FDA, and international guidelines.
Contribute to process improvements within the medical writing function.
Qualifications:
Bachelor’s degree required (Bachelor of Science preferred); higher degrees (MS, PharmD, PhD, MD) are advantageous and may substitute for years of experience.
Minimum of 2 years of relevant industry experience in medical or regulatory writing within healthcare, academia, or related fields.
Preferred certifications: AMWA or equivalent with a specialty in pharmaceutical writing.
Proficiency in clinical development documentation with a solid understanding of statistical data.
Exceptional communication skills—both written and verbal—with high attention to detail.
Knowledge of Common Technical Document (CTD) templates, regulatory requirements, and document submission standards.
Strong working knowledge of electronic document management systems and software tools in a Windows environment.
Work Arrangement:
Full-time remote position (within the United States).
Compensation & Benefits:
Competitive salary tailored to the role and market.
Diverse health insurance plans for you and your family.
Competitive retirement planning offerings to support long-term financial goals.
Global Employee Assistance Programme (TELUS Health) with 24/7 access to over 80,000 specialized professionals.
Life assurance and a variety of country-specific optional benefits, including:
Childcare vouchers
Bike-to-work schemes
Discounted gym memberships
Health assessments
Subsidized travel passes
Diversity & Inclusion:
ICON is committed to an inclusive, accessible, and respectful workplace for all employees. We are an equal opportunity employer and do not discriminate based on race, gender, disability, veteran status, or other protected categories.
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