Job Title:
Senior Medical Writer
Location:
Remote – United States
Job ID:
2025-118790
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 a global leader in clinical research and healthcare intelligence, known for its innovation, inclusive culture, and commitment to excellence in clinical development.
Key Responsibilities:
Prepare, write, and review regulatory and scientific documents for submission to health authorities.
Represent Regulatory Scientific Writing (RSW) on project teams and liaise with clinical, pharmacovigilance, and other key contributors.
Drive content development in collaboration with Global Regulatory Project Teams (GRPT).
Interpret scientific and clinical data to ensure alignment with regulatory requirements.
Manage document timelines, coordinate reviews, and resolve content issues during drafting.
Ensure adherence to ICH, regulatory, and internal documentation standards and formats.
Support process improvements and resource management discussions with RSW leadership.
Candidate Profile:
Education:
Bachelor’s degree required (Science preferred).
Advanced degree (MS, PharmD, PhD, MD) preferred.
AMWA or other medical writing certification preferred.
Experience:
Minimum 2 years of relevant experience in medical/regulatory writing or related roles (e.g., clinical research, regulatory affairs).
Proven ability to write high-level regulatory documents, with knowledge of US/international regulatory requirements.
Experience with Common Technical Documents (CTD), electronic document systems, and scientific content translation.
Skills:
Strong command of grammar, consistency, and document clarity.
Excellent communication skills and attention to detail.
Familiarity with statistics and clinical data presentation.
Proficient in Windows-based software applications.
Benefits:
Competitive salary.
Annual leave, health insurance, life assurance.
Retirement planning support.
Global Employee Assistance Programme via TELUS Health.
Optional benefits: childcare vouchers, gym discounts, bike schemes, health checks, etc.
🔗 Learn more about ICON’s benefits
Diversity & Inclusion:
ICON is committed to an inclusive, accessible work environment. They provide equal opportunities and necessary accommodations throughout the application and employment process.
Application Note:
Even if you don’t meet every qualification, you are encouraged to apply.
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