Senior Medical Writer
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Job Description
Principal Medical Writer at ICON leading the development of regulatory and clinical documents. Collaborating across teams to ensure high-quality outputs and adherence to standards.
Responsibilities:
- Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations
- Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity
- Collaborate with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development
- Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards
- Mentor and train junior medical writers, fostering a culture of excellence and professional growth
- Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs
- Act as a lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs
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 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
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