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ICON plc

Principal Medical Writer

ICON plc

. Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations .

Posted 10/15/2026full-timeRemote • Pennsylvania • United States, FranceLeadWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in medical writing with a focus on regulatory submissions and clinical documentation, while providing leadership and mentorship to junior writers. Maintains a strong understanding of regulatory requirements and industry standards to ensure high-quality deliverables.

Highest-signal resume keywords
Medical WritingRegulatory SubmissionsClinical DocumentationLeadershipCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical Study ReportsProtocolsRegulatory DocumentsEditing SkillsWriting Skills
Soft Skills
Interpersonal SkillsCollaboration
Industry Keywords
Life SciencesPharmacyRegulatory RequirementsIndustry StandardsBiologics

About the role

Key responsibilities & impact
  • Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations
  • Lead the preparation and review of clinical study reports, protocols, and other regulatory documents
  • Collaborate with clinical research, biostatistics, and regulatory affairs teams to gather and synthesize information
  • Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards
  • Mentor and train junior medical writers
  • Stay current with industry trends and regulatory guidelines
  • Act as lead medical writer for complex projects
  • Lead clinical/regulatory marketing approval applications for new biologics and drugs
  • Perform all duties of a Senior Medical Writer, plus leadership of regulatory approval application writing

Requirements

What you’ll need
  • A bachelor's degree in life sciences, pharmacy, or a related discipline
  • Significant experience in medical writing, particularly in regulatory submissions and clinical documentation
  • Strong understanding of regulatory requirements and industry standards for clinical writing
  • Exceptional writing and editing skills, with a keen eye for detail and clarity
  • Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders
  • Legal right to work in the country where the role is based

Benefits

Comp & perks
  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways