Medical Writer 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. As a Senior Medical Writer at ICON, you will lead the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.

You will take ownership of medical writing deliverables, applying your expertise to complex challenges. Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives. Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles,



and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.

You will have a strong foundation in medical writing, with the experience to work independently and guide others. Bachelor's degree in a relevant scientific discipline or healthcare-related field Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills Solid understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process. Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based. 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 coverageEmployee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

📌 Senior Medical Writer - Regulatory Writing (Prince Edward Island)
🏢 ICON Strategic Solutions
📍 Prince Edward Island