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Principal Medical Writer

5+ years
Not Disclosed
10 July 18, 2025
Job Description
Job Type: Full Time 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: Remote, United States
Work Mode: Remote
Experience Required: Minimum 5 years in medical writing (oncology preferred)
Job ID: 2025-117948
Company: ICON plc – Strategic Solutions Division


Job Summary:

ICON plc is seeking a Principal Medical Writer to join our world-renowned clinical research organization. In this senior-level position, you’ll take ownership of medical writing deliverables across regulatory and clinical documentation, including protocols and study reports. Ideal for experienced professionals with a background in clinical trial documentation and regulatory writing, this is a fully remote role offering competitive benefits and the opportunity to shape high-impact, global studies.


Key Responsibilities:

  • Lead all aspects of medical writing for complex clinical programs.

  • Draft, edit, and finalize clinical study reports, protocols, IBs, and other regulatory documents.

  • Contribute to protocol development for first-in-human oncology studies.

  • Collaborate cross-functionally and manage review cycles using platforms like Documentum and PleaseReview.

  • Interpret clinical and statistical data, presenting it clearly for diverse audiences.

  • Serve as lead writer across multiple concurrent studies.

  • Ensure compliance with ICH-GCP, regulatory standards, and internal SOPs.


Required Skills & Qualifications:

  • Advanced degree in scientific, clinical, or regulatory field (preferred).

  • Minimum 5 years of experience in a lead medical writing role within pharma or CRO.

  • Oncology writing experience preferred.

  • Deep knowledge of regulatory writing standards and guidelines.

  • Strong command of MS Word, Excel, Outlook, and PowerPoint.

  • Excellent written and verbal communication skills.

  • Skilled in prioritizing and managing multiple concurrent projects.

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


Perks & Benefits:

  • Competitive salary

  • Generous annual leave

  • Comprehensive health insurance plans for individuals and families

  • Competitive retirement and savings programs

  • 24/7 global Employee Assistance Programme via TELUS Health

  • Life insurance coverage

  • Optional country-specific benefits like gym discounts, childcare vouchers, travel subsidies, etc.

  • Diverse, inclusive workplace culture


Company Description:

ICON plc is a global leader in clinical research services, offering comprehensive development and commercialization solutions for the pharmaceutical, biotechnology, and medical device industries. With a focus on healthcare intelligence and data-driven innovation, ICON delivers results that improve patient outcomes and accelerate drug development worldwide.


Call to Action:

Are you ready to lead complex clinical documentation projects from anywhere in the US? Apply now to join ICON as a Principal Medical Writer and take your medical writing career to new heights.

Apply Today at: ICON Careers – Principal Medical Writer