Principal Medical Writer

ICON plc

Principal Medical Writer at ICON overseeing medical writing workstreams and leading regulatory submissions. Collaborate with teams and mentor junior writers in a global healthcare research organization.

Posted 7/15/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, particularly in regulatory submissions and clinical documentation, while ensuring adherence to industry standards and regulatory requirements. Capable of mentoring junior writers and collaborating effectively with cross-functional teams to produce high-quality deliverables.

Highest-signal resume keywords

Medical WritingRegulatory SubmissionsClinical DocumentationExceptional Writing SkillsCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical WritingRegulatory SubmissionsClinical DocumentationWriting SkillsEditing Skills

Soft Skills

Communication SkillsInterpersonal SkillsMentoring

Industry Keywords

Regulatory RequirementsClinical Study ReportsProtocolsBiologicsDrugs

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 to ensure accuracy and clarity
Collaborate with cross-functional teams to gather and synthesize information for document development
Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards
Mentor and train junior medical writers, fostering a culture of excellence and professional growth
Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs
Act as a lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs

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

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