Job Title:
Senior Medical Writer
Location:
United States (Remote)
Job ID:
2025-118493
Department:
Medical Writing (ICON Strategic Solutions)
Job Type:
Full-Time, Remote
Application Contact:
Name: Brendan Hoey
Message Option: Send a message via job platform
Other Roles: View other roles by Brendan
Job Description:
About ICON:
ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence, offering cutting-edge solutions across clinical trials.
Key Responsibilities:
Prepare, write, edit, and review high-quality regulatory documents, ensuring they meet regulatory requirements and are supported by scientific data for submission to regulatory agencies.
Serve as the RSW representative on project teams, collaborating with team members such as Clinical, Pharmacovigilance, CPPM, and other departments.
Participate in project management for compound programs, ensuring accurate and timely completion of regulatory submissions.
Collaborate with GRPT members to define content and project timelines, ensuring deliverables are met.
Assimilate and interpret various sources of scientific data and research, converting them into regulatory documents as required.
Coordinate the review and approval process, resolving document content issues during writing.
Maintain regular communication with RSW leadership regarding project timelines and milestone progress.
Ensure compliance with ICH guidelines and divisional SOPs, following proper grammar, format, and conventions in document preparation.
Contribute to the design and implementation of process improvements within the writing team.
Qualifications & Experience:
Education: Bachelor’s degree required; a Bachelor of Science is preferred. A relevant advanced degree (MS, PharmD, PhD, MD) is preferred and may substitute for years of experience.
Experience: Minimum 2 years of relevant experience in medical/regulatory writing, healthcare industry, or academia.
Skills:
High-level content writing experience with clinical development regulatory documents.
Experience with statistical concepts and techniques.
Strong written and oral communication skills, attention to detail, and ability to assimilate and interpret scientific content.
Knowledge of US and international regulations and submission requirements.
Familiarity with Common Technical Document templates and electronic document management systems.
ICON Employee Benefits Include:
Generous annual leave
Health insurance options for you and your family
Competitive retirement savings plans
Global Employee Assistance Programme (TELUS Health)
Life assurance
Country-specific optional benefits, such as:
Childcare vouchers
Bike-to-work schemes
Discounted gym memberships
Subsidized travel passes
Health assessments
More information: ICON Benefits Overview
Diversity & Inclusion Commitment:
ICON is committed to fostering an inclusive and accessible environment for all candidates, ensuring equal employment opportunity without discrimination.
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