Senior Medical Writer: Regulatory & Clinical Lead

ProPharma Group; Northern (KY); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Hybrid work model

Equal Opportunity Employer

Job summary

ProPharma Group seeks a Principal Medical Writer to lead medical writing efforts across regulatory submissions and clinical documentation. You will author and edit complex documents, coordinate cross-functional teams, and ensure compliance with ICH and regional guidelines.

The role requires 7+ years in clinical/regulatory writing, strong communication, and project management skills, with a preference for experience in submissions for drugs, biologics, or devices. Hybrid work available.

Qualifications

• Minimum 7 years of experience in writing clinical and/or regulatory documents.
• Advanced knowledge of clinical research principles and regulatory requirements.
• Experience with regulatory submissions and AMA style.

Responsibilities

• Manage clinical and regulatory documents across drugs, biologics, devices and diagnostics.
• Independently author/edit high-quality medical writing deliverables.
• Lead cross-functional coordination to meet timelines and budgets.
• Review protocols, study reports, IBs, ICFs, CSRs, PBRERs and submissions.
• Mentor junior writers and communicate with clients and SMEs as needed.

Skills

Clinical writing

Regulatory writing

Project management

FDA/regulatory knowledge

MS Word proficiency

Communication skills

AMA style

Team collaboration

Time management

Client relationship management

Education

Bachelor's degree or higher in life sciences

Job description

ProPharma Group seeks a Principal Medical Writer to lead medical writing efforts across regulatory submissions and clinical documentation. You will author and edit complex documents, coordinate cross-functional teams, and ensure compliance with ICH and regional guidelines.

The role requires 7+ years in clinical/regulatory writing, strong communication, and project management skills, with a preference for experience in submissions for drugs, biologics, or devices. Hybrid work available.