Principal Medical Writer
ICON plc
Summary
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.
Job description
What You Will Do
You 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 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
Your Profile
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
Requirements
- 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
Benefits
- Competitive base salary
- Performance related incentives
- Medical, Dental & Vision
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes
- Wellbeing resources
- Learning and development opportunities
Company overview
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.