Senior Medical Writer & Regulatory Lead

ProPharma; Raleigh (NC); Hybrid; USD 110,000 - 150,000; Full time

Job summary

ProPharma is seeking a senior medical writer to oversee the creation of regulatory and clinical documents across drugs, biologics, and medical devices. The role requires leading medical writing teams, coordinating with clinical operations, data management, and regulatory affairs to ensure timely, compliant submissions.

The candidate will author and edit high-quality reports, CSRs, protocols, and PI summaries, while mentoring junior writers and maintaining industry-standard documentation

Qualifications

• Bachelor’s degree or higher in medical or scientific discipline.
• 7+ years of experience in writing clinical and regulatory documents for drugs, biologics, and/or medical devices/diagnostics.
• Experience with regulatory guidelines and submissions.
• Excellent written and verbal communication skills.

Responsibilities

• Manage clinical program documents (protocols, protocol amendments, IBs, ICFs, study reports, and other regulatory documents) for assigned clients.
• Lead cross-functional coordination to manage medical writing and QC deliverables.
• Independently author high-quality medical writing deliverables across clinical research and regulatory areas.
• Supervise and mentor less experienced medical writers as needed.
• Ensure compliance with regulatory standards and client templates (ICH E3/E6, EU MDR/IVDR).
• Strive to complete deliverables on time and within budget while managing client expectations.
• Coordinate with SMEs to produce accurate, consistent content and maintain audit trails.

Skills

Clinical research principles

FDA regulatory knowledge

Regulatory submissions

MS Word proficiency

Attention to detail

Communication skills

Team collaboration

Education

Bachelor’s degree or higher in medical or scientific discipline

7+ years writing clinical/regulatory documents

Tools

MS Word

Job description

ProPharma is seeking a senior medical writer to oversee the creation of regulatory and clinical documents across drugs, biologics, and medical devices. The role requires leading medical writing teams, coordinating with clinical operations, data management, and regulatory affairs to ensure timely, compliant submissions.

The candidate will author and edit high-quality reports, CSRs, protocols, and PI summaries, while mentoring junior writers and maintaining industry-standard documentation