Senior Medical Writer – US/East Coast

Prime is hiring a Senior Medical Writer for our New York, United States office. This full-time position offers an opportunity to lead medical communications projects that translate complex clinical science into compelling, regulatory-compliant content for healthcare and scientific audiences.

Position Summary

As Senior Medical Writer at Prime, you'll own end-to-end development of regulatory, scientific, and medical communications across multiple therapeutic areas. You'll drive strategic writing initiatives that support product approvals, clinical publications, and evidence generation while collaborating with clinical, regulatory, and commercial teams. This senior-level role combines hands-on writing expertise with project leadership and mentorship of junior writers.

What You'll Do

• Author regulatory documents including clinical study reports, regulatory submissions, and compliance-critical materials
• Lead development of clinical publications and scientific abstracts for peer-reviewed journals and medical conferences
• Create medical information materials, healthcare provider resources, and evidence summaries
• Synthesize clinical trial data and scientific literature to support regulatory and communication objectives
• Partner with clinical, regulatory, and scientific stakeholders to define writing strategy and messaging
• Maintain compliance with FDA regulations, ICH guidelines, and industry standards across all deliverables
• Review, edit, and mentor writers on regulatory writing, publication strategy, and medical communication best practices

What We're Looking For

• Bachelor's degree in life sciences, medicine, pharmacy, or related scientific field (advanced degree preferred)
• 5+ years of professional medical writing experience in regulatory, scientific publications, or clinical communications
• Deep knowledge of FDA regulations, regulatory submission processes, and ICH guidelines
• Strong ability to interpret clinical data, synthesize scientific evidence, and write with precision
• Excellent written communication skills with proven ability to simplify complex medical concepts
• Experience managing multiple writing projects simultaneously with strong organizational skills
• Commitment to accuracy, attention to detail, and understanding of compliance requirements

More About Prime

Prime partners with healthcare companies and organizations to develop high-quality medical communications and evidence-based solutions. We're dedicated to supporting the safe, effective delivery of healthcare products while ensuring regulatory compliance and scientific integrity.

Applying for This Role

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