Remote Senior Director, Pharma & Med Device Writing

Criterion Edge; Los Angeles (CA); Remote; USD 180,000 - 240,000; Full time

Job summary

Criterion Edge is seeking an experienced Senior Director to lead its Pharmaceutical Writing Services group, combining hands-on regulatory writing for pharmaceutical, biologic, and medical device contexts with strategic leadership. You will oversee end-to-end CER projects under EU MDR, manage complex clinical submission programs, and mentor writers while directly authoring critical documents.

This is a hands-on leadership role with remote flexibility.

Qualifications

• 8+ years of pharmaceutical and/or biologic regulatory medical writing with hands-on authorship.
• End-to-end leadership of pharmaceutical writing programs and submission workstreams.
• Ability to develop regulatory writing strategies across clinical, regulatory, biostatistics, safety, and other functions.
• Experience advising clients on regulatory guidance and submission expectations.

Responsibilities

• Lead Criterion Edge's Pharmaceutical Writing Services group with accountability for quality, delivery, and staff development.
• Establish consistent writing processes, quality standards, and maintain direct authorship for high-complexity deliverables.
• Serve as the senior pharmaceutical regulatory medical writing expert for complex CER projects and submissions.
• Lead client scoping discussions, proposals, kickoffs, and ongoing senior-level client communications.
• Develop regulatory and medical writing strategies tailored to each project.
• Plan deliverables, budgets, timelines, resource needs; oversee execution and risk management.
• Independently author or lead regulatory documents and major submission workstreams; manage EU MDR CER projects end-to-end.
• Mentor Principal and Senior Medical Writers; provide substantive scientific and regulatory oversight.
• Direct cross-functional teams with regulatory, clinical, biostatistics, safety, and quality colleagues.
• Support business development with technical writing expertise during proposals and client meetings.

Skills

Pharmaceutical Writing

Regulatory Medical Writing

Clinical Evaluation Reports (CER)

EU MDR CER Leadership

Client Communication

Education

Bachelor's degree or higher in life sciences, medicine, or engineering

Advanced degree (MS, PharmD, PhD, MD) preferred

Tools

eCTD knowledge

Regulatory strategy development

Job description

Criterion Edge is seeking an experienced Senior Director to lead its Pharmaceutical Writing Services group, combining hands-on regulatory writing for pharmaceutical, biologic, and medical device contexts with strategic leadership. You will oversee end-to-end CER projects under EU MDR, manage complex clinical submission programs, and mentor writers while directly authoring critical documents.

This is a hands-on leadership role with remote flexibility.