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About the Role

As a Principal Medical Writer at ICON, you will lead the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. You will oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations.

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.
• Perform all duties of a Senior Medical Writer.
• Lead regulatory approval application writing.

Requirements

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

Skills

• 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.

Experience Level

• Principal
• Senior

Education Level

• 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

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

About the Company

• 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.

Equal Opportunity

• ICON is an equal opportunity employer.
• We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
• If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.