Principal Medical Writer

What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various 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.
• 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.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

Required qualifications and experience:

• 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.

Principal Medical Writer

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

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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

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