Principal Medical Writer
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Job Description
Principal Medical Writer leading regulatory and clinical documents for ICON, a global healthcare intelligence and clinical research organization. Guiding submissions for new biologics and drugs.
Responsibilities:
- Lead the development of high-quality regulatory and clinical documents communicating scientific and medical information
- Oversee medical writing workstreams and ensure deliverables meet quality and timeline expectations
- Lead preparation and review of clinical study reports, protocols, and other regulatory documents
- Collaborate with clinical research, biostatistics, and regulatory affairs teams to gather and synthesize information
- Provide guidance on medical-writing best practices and ensure adherence to regulatory requirements and internal standards
- Mentor and train junior medical writers
- Stay current with industry trends and regulatory guidelines
- Act as lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs
- Perform all Senior Medical Writer duties plus leadership of regulatory approval application writing
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
- At least 5 years of experience writing for pharma or biotechnology preferred
- 3+ years of electronic documents and submissions required
- Experience with writing key documents included in major international regulatory submissions required, including Clinical study reports, IBs, and Protocols
- Experience managing writing activities for a major international regulatory submission preferred
- Legal right to work in the country where the role is based
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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