Principal Medical Writer

ICON plc

8d

About The Position

At ICON Strategic Solutions, the Principal Medical Writer works in a sponsor-dedicated model supported by ICON’s global expertise. The role leads the development of high-quality regulatory and clinical documents that communicate scientific and medical information effectively. It includes all duties of a Senior Medical Writer, as well as leadership of regulatory approval application writing.

The Principal Medical Writer oversees medical writing workstreams and ensures deliverables meet quality and timeline expectations. The role involves leading complex projects and clinical/regulatory marketing approval applications for new biologics and drugs, collaborating with cross-functional teams, providing guidance on writing practices, and mentoring junior writers.

Requirements

• 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 attention to detail and clarity.
• Excellent communication and interpersonal skills for collaborating with diverse teams and stakeholders.
• Ability to manage competing priorities and develop a team.
• Legal right to work in the country where the role is based.

Responsibilities

• Oversee medical writing workstreams and ensure 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 clinical research, biostatistics, regulatory affairs, and other teams to gather and synthesize information for document development.
• Provide guidance on medical writing best practices and ensure adherence to regulatory requirements and internal standards.
• Mentor and train junior medical writers, fostering professional growth and a culture of excellence.
• Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs.
• Act as lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs.
• Lead regulatory approval application writing, in addition to the duties of a Senior Medical Writer.

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