Senior Director, Pharmaceutical Writing Services

About this role

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, authoring, review coordination, issue resolution, and delivery of submission-ready documents, rather than experience limited to discrete sections, editing, quality control, or project management.

• Demonstrated ability to develop and communicate pharmaceutical and biologic clinical regulatory writing strategies, coordinating across clinical, regulatory, biostatistics, safety, and other functions.

• Demonstrated ability to advise clients on pharmaceutical regulatory guidance, submission expectations, and implications for clinical and regulatory documents.

Relevant pharmaceutical and biologic regulatory writing experience may include:

•
Regulatory submissions: INDs, NDAs, BLAs, and global regulatory dossiers.

•
CTD clinical documentation: Clinical Overviews, Clinical Summaries, Integrated Summaries of Safety (ISS), and Integrated Summaries of Efficacy (ISE).

•
Clinical development documents: Clinical Study Reports (CSRs), clinical study protocols, and Investigator's Brochures (IBs).

•
Regulatory authority interactions: Regulatory briefing documents and responses to regulatory authority questions.

•
Safety and benefit-risk documentation: Integrated safety evaluations, benefit-risk assessments, and related regulatory documentation.

•
Regulatory strategy and advisory services: Development of regulatory writing strategies and advising clients on evolving regulatory requirements and submission expectations.

Experience planning and coordinating clinical submission documents across eCTD Modules 2 through 5, including integrated clinical summaries and major marketing application workstreams, is strongly preferred.
Candidates must demonstrate the ability to lead pharmaceutical writing engagements independently, including development of the writing strategy, coordination of cross-functional reviews, resolution of conflicting reviewer comments, and direct communication with sponsors and regulatory stakeholders.Required Medical Device Experience
Candidates must have:

• At least 5 years of direct medical device regulatory or clinical writing experience, with substantial end-to-end EU MDR CER leadership experience.

• Demonstrated ability to independently scope, author, lead, and finalize regulator-ready CERs, including resolving complex clinical evidence issues and addressing Notified Body questions without day-to-day supervision. Experience limited to editing, quality control, review, project management, or authorship of individual CER sections is insufficient.

• Demonstrated ability to develop and communicate regulatory strategies for medical device programs.

• Demonstrated ability to guide clients on regulatory updates, changing requirements, and the potential impact of those changes on clinical and regulatory documentation.

Independent CER leadership must include the ability to direct and perform the following activities, as applicable:

•
Clinical evaluation planning and strategy: Clinical Evaluation Plan (CEP) development, project scoping, and clinical evaluation strategy.

•
Literature review and clinical evidence assessment: State-of-the-art development, systematic literature review strategy, literature screening, clinical data appraisal, and evidence synthesis.

•
Clinical evaluation and benefit-risk assessment: Evaluation of device safety, performance, clinical benefits, equivalence (where applicable), and benefit-risk conclusions.

•
PMS and PMCF integration: Evaluation and integration of post-market surveillance (PMS) and post-market clinical follow-up (PMCF) data into clinical evaluations.

•
CER development and regulatory support: Authoring and finalization of regulator-ready CERs, lifecycle updates, and responses to Notified Body questions and deficiencies.

•
Regulatory strategy and client advisory: Interpretation of evolving EU MDR, MEDDEV, MDCG, and related regulatory requirements and advising clients on their implications for clinical evaluation.

Candidates must demonstrate current working knowledge of EU MDR clinical evaluation requirements, MEDDEV 2.7/1 Rev. 4, and applicable MDCG guidance.Preferred U.S. Medical Device Submission Experience
Candidates should also have experience authoring, leading, or substantially contributing to U.S. medical device regulatory documentation; direct 510(k) authorship is preferred.
Relevant experience may include:

•
FDA regulatory submissions: 510(k), De Novo, and Premarket Approval (PMA) submissions.

•
Regulatory and scientific documentation: Predicate device comparisons, substantial…