Criterion Edge
Criterion Edge is seeking an experienced Senior Director to lead its Pharmaceutical Writing Services group, providing scientific, technical, and operational leadership for pharmaceutical writing engagements and complex medical device clinical evaluations. The role requires substantial hands-on expertise in authoring and reviewing complex regulatory documents for pharmaceuticals, biologics, and medical devices under EU MDR and U.S. FDA regulations. This hands-on writing leadership position involves independent project management, client advisory, and team mentorship while maintaining direct authorship capacity for high-complexity deliverables.
Headquarters
San Luis Obispo, California, United States
Company Size
11-50 employees
Criterion Edge is a regulatory writing consultancy that provides best-in-class regulatory writing services for the medical device, biopharma/pharma, and in‑vitro diagnostic industries. They prepare submission‑ready regulatory and clinical documents—such as regulatory submissions, clinical study reports, labeling, and other compliance materials—to help clients meet agency requirements. Branded “The Regulatory Writing Experts,” Criterion Edge combines scientific and regulatory knowledge to improve clarity, consistency, and the efficiency of the approval process. They work with sponsors and manufacturers to translate complex data into clear, compliant regulatory communications.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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