Principal Medical Writer

Job Summary

Leading the development of high-quality regulatory and clinical documents, the full-time Principal Medical Writer will oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations in a remote environment.

Key responsibilities:

• Prepare and review clinical study reports, protocols, and other regulatory documents for accuracy and clarity
• Collaborate with cross-functional teams to gather and synthesize information for document development
• Mentor and train junior medical writers while staying current with industry trends and regulatory guidelines

Required qualifications:

• 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 for effective collaboration with diverse teams