Principal Medical Writer

ICON plc

3d

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information.

Requirements

• Solid experience in medical writing, with the ability to manage competing priorities and develop your team.
• 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.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

• 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, including clinical research, biostatistics, and regulatory affairs, 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.
• Include all duties of a Senior Medical Writer, as well as leadership of regulatory approval application writing.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal