Principal Medical Writer

About the role

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Key Responsibilities

• 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
• Includes all duties of a Senior Medical Writer, as well as leadership of regulatory approval application writing

Required Qualifications and Experience

• Solid 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

What You Will Do

You will oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations.

Your Profile

You will have solid experience in medical writing, with the ability to manage competing priorities and develop your team.

ICON Can Offer You

• A competitive salary
• A range of additional benefits, including various annual leave entitlements, health insurance offerings, competitive retirement planning offerings, a global Employee Assistance Programme, flexible country-specific optional benefits, and more

Benefits Examples

• Varying annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• A global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

At ICON

• We're dedicated to providing an inclusive and accessible environment for all candidates
• We're committed to providing a workplace free of discrimination and harassment

Interested in the Role?

If you're unsure if you meet all of the requirements, we encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.