Description
As a Principal Medical Writer at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
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 synthesise 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
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
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