Senior Medical Writer, Devices & Regulatory Submissions

ProPharma Group; Northern (KY); Hybrid; USD 95,000 - 125,000; Full time

Benefits offered by this job

Hybrid work model

Equal opportunity employer

Job summary

ProPharma Group is seeking a senior medical writer to lead authoring and coordination of regulatory submissions and clinical study documents. You will collaborate with medical writing leadership, operations, and clients to deliver high-quality materials on time.

The role emphasizes advanced knowledge of clinical research, FDA/regulatory guidelines, and strong communication and project management skills. A bachelor’s degree and 7+ years of experience in medical writing are required, with hybrid

Qualifications

• Advanced knowledge of clinical research principles and ability to interpret and present data.
• Strong understanding of FDA and other regulatory guidelines.
• Excellent project management and communication skills.

Responsibilities

• Authors and edits high-quality medical writing deliverables across clinical, safety, regulatory, device, and diagnostic documents.
• Leads cross-functional coordination to manage deliverables and timelines.
• Mentors junior writers and reviews peer documents.

Skills

Medical writing

Regulatory awareness

Project management

Communication

Education

Bachelor's degree or higher

Tools

MS Word

Job description

ProPharma Group is seeking a senior medical writer to lead authoring and coordination of regulatory submissions and clinical study documents. You will collaborate with medical writing leadership, operations, and clients to deliver high-quality materials on time.

The role emphasizes advanced knowledge of clinical research, FDA/regulatory guidelines, and strong communication and project management skills. A bachelor’s degree and 7+ years of experience in medical writing are required, with hybrid