Director of Medical Writing & Regulatory Strategy

PPG US ProPharma Group, LLC; Chicago (IL); Hybrid; USD 90,000 - 140,000; Full time

Job summary

ProPharma is seeking a senior Medical Writing/Quality Control leader to drive high-quality clinical and regulatory documents across various programs. You will oversee writing, QC, and project management, ensuring timelines and budgets are met while mentoring junior staff.

Ideal candidates will have 7+ years in medical writing/quality control, strong regulatory knowledge, and excellent stakeholder management. This role supports hybrid work with some travel as needed.

Qualifications

• Minimum 7 years of writing/quality control experience in clinical/regulatory docs.
• Minimum 5 years in project and resource management.
• Proven leadership and mentoring abilities.
• Strong regulatory submission knowledge and AMA style.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead medical writing and quality control deliverables across programs.
• Oversee project management, budgets, and resource allocation for client projects.
• Develop and maintain client relationships and drive business opportunities.
• Collaborate cross-functionally to improve processes and efficiency.
• Mentor junior writers/editors and ensure quality standards.

Skills

Medical writing leadership

Quality control oversight

Regulatory knowledge

Budgeting & forecasting

Team mentoring

Client relationship management

Education

Bachelor’s or higher in medical/science

Tools

MS Word

Job description

ProPharma is seeking a senior Medical Writing/Quality Control leader to drive high-quality clinical and regulatory documents across various programs. You will oversee writing, QC, and project management, ensuring timelines and budgets are met while mentoring junior staff.

Ideal candidates will have 7+ years in medical writing/quality control, strong regulatory knowledge, and excellent stakeholder management. This role supports hybrid work with some travel as needed.