Senior Director, Pharmaceutical and Medical Device Writing Services

This is a remote position. Position Summary Criterion Edge is seeking an experienced Senior Director to lead its Pharmaceutical Writing Services group, with substantial hands-on pharmaceutical and biologic regulatory medical writing expertise and the ability to independently author and lead complex medical device clinical evaluations as needed. The Senior Director will provide scientific, technical, and operational leadership for pharmaceutical writing engagements, including oversight of complex clinical submission programs, client relationships, writer development, resourcing, and quality. The successful candidate must also be capable of independently leading end-to-end Clinical Evaluation Report (CER) projects under the EU MDR, including responses to Notified Body questions. This is a hands-on writing leadership role, not solely a people-management, regulatory affairs, or review position. The Senior Director must be able to personally author and critically review complex pharmaceutical and medical device documents and serve as a technical authority for writers, project teams, and clients. Required Pharmaceutical Writing Experience Candidates must have: At least 8 years of direct pharmaceutical and/or biologic regulatory medical writing experience, with substantial recent hands-on authorship of complex clinical and regulatory submission documents. Demonstrated end-to-end leadership of pharmaceutical writing programs or major submission workstreams, including planning, author