Principal 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 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.What You Will DoYou will oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations.Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarityCollaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document developmentProviding guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standardsMentoring and training junior medical writers, fostering a culture of excellence and skilled growthStaying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputsActing as a lead medical writer for complex projects and leading clinical/regulatory marketing approval applications for new biologics and drugsThe position includes all duties of a Senior Medical Writer, as well as leadership of regulatory approval application writingProfileYou will have solid experience in medical writing, with the ability to manage competing priorities and develop your team.Required Qualifications and ExperienceA bachelor's degree in life sciences, pharmacy, or a related disciplineSignificant experience in medical writing,



particularly in regulatory submissions and clinical documentationStrong understanding of regulatory requirements and industry standards for clinical writingExceptional writing and editing skills, with a keen eye for detail and clarityExcellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholdersEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Visit our careers site to read more about the benefits ICON offers.Inclusion and AccessibilityICON is an equal opportunity employer.We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.ICON is an award-winning workplace that enables you to make a difference to patients' lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.If you're as driven as we are, join us. you'll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry. #J-18808-Ljbffr

📌 Principal Medical Writer (Montreal)
🏢 ICON Strategic Solutions
📍 Montreal