[Hiring] Senior Director, Pharmaceutical and Medical Device Writing Services @Criterion Edge Professional Services

Role Description

This is a remote position.

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
• 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.

Qualifications

• 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.
• Demonstrated ability to develop and communicate pharmaceutical and biologic clinical regulatory writing strategies.
• 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 is strongly preferred.
• Demonstrated ability to lead pharmaceutical writing engagements independently.

Requirements

• 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.
• Demonstrated ability to develop and communicate regulatory strategies for medical device programs.
• Demonstrated ability to guide clients on regulatory updates and changing requirements.
• Independent CER leadership must include the ability to direct and perform the following activities:
• Clinical evaluation planning and strategy.
• Literature review and clinical evidence assessment.
• Clinical evaluation and benefit-risk assessment.
• PMS and PMCF integration.
• CER development and regulatory support.
• Regulatory strategy and client advisory.
• Demonstrate current working knowledge of EU MDR clinical evaluation requirements, MEDDEV 2.7/1 Rev. 4, and applicable MDCG guidance.

Company Description