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Senior Medical Writer

2+ years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.