[Hiring] Principal Medical Writer @ICON plc

Role Description

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.

• 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.
• The position includes all duties of a Senior Medical Writer, as well as leadership of regulatory approval application writing.

Qualifications

• 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.
• At least 5 years of experience writing for pharma or biotechnology preferred.
• 3+ years of electronic documents and submissions required.
• Experience with writing key documents included in major international regulatory submissions required, like Clinical study reports, IBs, Protocols.
• Experience managing writing activities for a major international regulatory submission preferred.

Requirements

• Solid experience in medical writing, with the ability to manage competing priorities and develop your team.

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.
• Benefits may vary depending on role and location.