Director, Medical Writing & Regulatory Strategy

ProPharma Group; Northern (KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

ProPharma Group is seeking a senior leader to head the medical writing and quality control function across clinical and regulatory documents for drugs, biologics, and devices. You will manage projects, budgets, and staff while building strong client relationships and leading cross-functional teams.

The role requires 7+ years of experience in medical writing/quality control, expert knowledge of regulatory standards, and the ability to drive process improvements in a fast-paced environment.

Qualifications

• Minimum 7 years writing/quality control experience for drugs, biologics, devices/diagnostics

Responsibilities

• Lead medical writing/quality control deliverables across clinical/regulatory documents
• Manage project and resource needs, timelines, and budgets
• Mentor and coach junior writers/editors
• Develop and defend proposals, bids, and budgets with business development
• Drive process improvements in writing/quality control workflows
• Collaborate with clients, recruiters, and leadership for resource planning

Skills

Leadership

Project management

Communication

Process improvement

Budgeting/forecasting

Relationship building

Education

Bachelor’s degree or higher in medical/scientific discipline

Tools

MS Word

Job description

ProPharma Group is seeking a senior leader to head the medical writing and quality control function across clinical and regulatory documents for drugs, biologics, and devices. You will manage projects, budgets, and staff while building strong client relationships and leading cross-functional teams.

The role requires 7+ years of experience in medical writing/quality control, expert knowledge of regulatory standards, and the ability to drive process improvements in a fast-paced environment.