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Lead the development of high-quality regulatory and clinical documents, including study reports and protocols. Oversee medical writing workstreams and mentor junior writers to ensure adherence to industry standards and timelines.
Requires a bachelor's degree in life sciences, pharmacy, or a related field with significant experience in regulatory submissions. Must possess exceptional writing skills and a strong understanding of clinical writing industry standards.
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.
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
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
Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
ICON 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.
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
