[Hiring] Principal Medical Writer @ICON plc

Role Description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. 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.

You will oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations. Key responsibilities include:

• Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
• Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development.
• Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards.
• Mentoring and training junior medical writers, fostering a culture of excellence and professional growth.
• Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs.
• Acting as a lead medical writer for complex projects and leading clinical/regulatory marketing approval applications for new biologics and drugs.

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.
• Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

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.