Principal Medical Writer
ICON
Principal Medical Writer position leading development of regulatory and clinical documents in a sponsor-dedicated model. Requires medical writing expertise, team leadership capabilities, and deep knowledge of regulatory requirements for clinical submissions and drug approval processes.
Responsibilities
- Oversee medical writing workstreams and ensure deliverables meet quality and timeline expectations
- Lead preparation and review of clinical study reports, protocols, and regulatory documents
- Collaborate with clinical research, biostatistics, and regulatory affairs teams to synthesize information
- Mentor and train junior medical writers, fostering professional development
- Lead complex projects and clinical/regulatory marketing approval applications for biologics and drugs
Requirements
- Bachelor's degree in life sciences, pharmacy, or related discipline
- Significant medical writing experience in regulatory submissions and clinical documentation
- Strong understanding of regulatory requirements and industry standards
- Exceptional writing, editing, and attention to detail
- Excellent communication and interpersonal skills for cross-functional collaboration
- Legal right to work in the country where role is based
Vacancy posted 2 days ago
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