About the role
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 Do:
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
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
Experience with Neuroscience is a big plus
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
#LI-NR1
#LI-Remote
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON 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 incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
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
Aplyr's read
ICON plc is a leading global provider of outsourced services in the pharmaceutical industry, attracting professionals in clinical research and data management.
What's promising
- •ICON plc has a strong global presence, enhancing its ability to manage international clinical trials effectively.
- •The company offers diverse career opportunities across various roles in clinical research and data analysis.
- •ICON's focus on innovation in pharmaceutical services supports its competitive edge in the industry.
What to watch
- •The pharmaceutical industry is highly regulated, which may limit flexibility in project execution.
- •ICON's reliance on large pharmaceutical clients could pose risks if partnerships dissolve.
- •The competitive nature of the CRO market may pressure ICON to maintain cost efficiency.
Why ICON plc
- •ICON plc specializes in comprehensive outsourcing solutions, differentiating it from competitors with narrower service scopes.
- •The company's integration of technology in clinical trials offers a unique advantage in data management.
- •ICON's strategic acquisitions have expanded its capabilities and market reach significantly.
Aplyr’s read is generated by AI from public sources. Was it useful?
About ICON plc
ICON plc is a global provider of outsourced development and commercialisation services to the pharmaceutical, biotechnology, and medical device industries.