About this role
Job title: Principal Medical Writer
About the Role ICON is seeking a Principal Medical Writer to lead the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. The role includes overseeing medical writing workstreams, mentoring junior writers, and leading complex regulatory submissions for new biologics and drugs.
What You'll Do
- Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity
- Overseeing medical writing workstreams and ensuring deliverables meet quality and timeline expectations
- Collaborating with cross-functional teams (clinical research, biostatistics, 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
What We're Looking For
- A bachelor's degree in life sciences, pharmacy, or a related discipline
- Significant experience in medical writing, particularly 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
- Solid experience in medical writing, with the ability to manage competing priorities and develop your team
Compensation & Benefits
- Competitive salary
- A range of benefits including annual leave entitlements; health insurance; retirement planning; Global Employee Assistance Programme with 24-hour access to a global network of professionals; life assurance; flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others).