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Principal Medical Writer

5+ 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:

Principal Medical Writer


Location:

United States (Remote)


Job ID:

2025-117948


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, committed to advancing innovative medical development through high-quality talent.


Key Responsibilities:

  • Manage all aspects of the medical writing function.

  • Write and review clinical study reports (CSRs), protocols, and other clinical/regulatory documents.

  • Contribute to the development of clinical protocols, particularly for first-in-human oncology studies.

  • Apply technical expertise using medical writing tools and platforms (e.g., PleaseReview, Documentum).

  • Draft, edit, and finalize clear, scientifically sound documents such as investigator brochures, summaries, and protocols.

  • Lead document preparation processes including statistical review integration, stakeholder feedback, and comment resolution.

  • Act as lead medical writer across complex programs and multiple studies.


Qualifications & Experience:

  • Advanced degree in a relevant scientific, clinical, or regulatory field preferred.

  • Minimum 5 years of experience in a lead medical writing role in the pharmaceutical or CRO industry.

    • Immunology experience is preferred but not required.

  • Excellent written and verbal communication skills.

  • Strong ability to interpret and present complex clinical and scientific data.

  • In-depth knowledge of current submission document requirements and regulatory guidelines.

  • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).

  • Ability to manage multiple projects and deadlines efficiently.

  • Must be legally authorized to work in the United States without the need for visa sponsorship.


ICON Employee Benefits Include:

  • Generous annual leave

  • Multiple health insurance plan options

  • 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 promotes a diverse, inclusive, and discrimination-free workplace. All qualified applicants are encouraged to apply regardless of background or whether all listed qualifications are met.