Senior Medical Writer—Regulatory & Clinical Solutions

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

Job summary

ProPharma is seeking a Principal Medical Writer to author and edit high-quality medical writing deliverables across clinical, safety, and regulatory areas. You will collaborate with cross-functional teams, manage timelines, and mentor junior writers in a hybrid, client-focused environment.

The role requires a Bachelor’s degree in a medical or scientific field and a minimum of 7 years in writing clinical or regulatory documents for drugs, biologics, devices, or diagnostics.

Qualifications

• Bachelor’s degree in medical or scientific discipline.
• Minimum 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics.

Responsibilities

• Author high-quality medical writing deliverables across clinical, safety, regulatory, device, and diagnostics areas.
• Lead and mentor junior writers and coordinate internal resources and timelines.
• Ensure deliverables comply with ICH/E3 or E6(R2) and applicable guidelines.
• Manage client expectations and communicate deliverable status.
• Review and QC documents and maintain audit trails.

Skills

Clinical research

Regulatory submissions

FDA regulations

MS Word

Project management

Communication

AMA style

Team leadership

Education

Bachelor's degree in medical/science

Tools

MS Word

eCTD software

Job description

ProPharma is seeking a Principal Medical Writer to author and edit high-quality medical writing deliverables across clinical, safety, and regulatory areas. You will collaborate with cross-functional teams, manage timelines, and mentor junior writers in a hybrid, client-focused environment.

The role requires a Bachelor’s degree in a medical or scientific field and a minimum of 7 years in writing clinical or regulatory documents for drugs, biologics, devices, or diagnostics.