Position Summary

Required Pharmaceutical Writing Experience

1. 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.
2. 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.
3. Demonstrated ability to develop and communicate pharmaceutical and biologic clinical regulatory writing strategies, coordinating across clinical, regulatory, biostatistics, safety, and other functions.
4. Demonstrated ability to advise clients on pharmaceutical regulatory guidance, submission expectations, and implications for clinical and regulatory documents.

1. Regulatory submissions: INDs, NDAs, BLAs, and global regulatory dossiers.
2. CTD clinical documentation: Clinical Overviews, Clinical Summaries, Integrated Summaries of Safety (ISS), and Integrated Summaries of Efficacy (ISE).
3. Clinical development documents: Clinical Study Reports (CSRs), clinical study protocols, and Investigator's Brochures (IBs).
4. Regulatory authority interactions: Regulatory briefing documents and responses to regulatory authority questions.
5. Safety and benefit-risk documentation: Integrated safety evaluations, benefit-risk assessments, and related regulatory documentation.
6. Regulatory strategy and advisory services: Development of regulatory writing strategies and advising clients on evolving regulatory requirements and submission expectations.

Required Medical Device Experience

1. At least 5 years of direct medical device regulatory or clinical writing experience, with substantial end-to-end EU MDR CER leadership experience.
2. 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.
3. Demonstrated ability to develop and communicate regulatory strategies for medical device programs.
4. Demonstrated ability to guide clients on regulatory updates, changing requirements, and the potential impact of those changes on clinical and regulatory documentation.

1. Clinical evaluation planning and strategy: Clinical Evaluation Plan (CEP) development, project scoping, and clinical evaluation strategy.
2. Literature review and clinical evidence assessment: State-of-the-art development, systematic literature review strategy, literature screening, clinical data appraisal, and evidence synthesis.
3. Clinical evaluation and benefit-risk assessment: Evaluation of device safety, performance, clinical benefits, equivalence (where applicable), and benefit-risk conclusions.
4. PMS and PMCF integration: Evaluation and integration of post-market surveillance (PMS) and post-market clinical follow-up (PMCF) data into clinical evaluations.
5. CER development and regulatory support: Authoring and finalization of regulator-ready CERs, lifecycle updates, and responses to Notified Body questions and deficiencies.
6. 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.

Preferred U.S. Medical Device Submission Experience

1. FDA regulatory submissions: 510(k), De Novo, and Premarket Approval (PMA) submissions.
2. Regulatory and scientific documentation: Predicate device comparisons, substantial equivalence assessments, clinical and performance evidence summaries, and supporting technical documentation.
3. FDA interactions: Preparation of responses to FDA questions, requests for additional information, and regulatory deficiencies.
4. Regulatory strategy and client advisory: Development of U.S. market access strategies and advising clients on evolving FDA requirements and submission expectations.

1. Lead Criterion Edge’s Pharmaceutical Writing Services group, with accountability for technical quality, delivery, staff development, and the successful execution of pharmaceutical and biologic regulatory writing engagements.
2. Establish consistent pharmaceutical writing processes, quality expectations, and technical review standards while maintaining direct authorship capacity for priority or high-complexity deliverables.
3. Serve as the senior pharmaceutical regulatory medical writing expert for complex clinical submission programs, while providing independent technical leadership for CER projects when needed.
4. Lead pharmaceutical client scoping discussions, proposal input, kickoffs, and ongoing senior-level client communications.
5. Develop and communicate regulatory and medical writing strategies appropriate to each project.
6. Guide clients on regulatory updates, changing requirements, emerging guidance, and their potential impact on regulatory strategy and documentation.
7. Plan pharmaceutical writing deliverables, budgets, timelines, resource requirements, and cross-functional review cycles; oversee execution and address delivery risks.
8. Independently author or lead pharmaceutical regulatory documents and major submission workstreams, and lead complex EU MDR CER projects from planning through finalization, including Notified Body deficiency responses.
9. Review complex scientific and regulatory documents for scientific accuracy, regulatory compliance, consistency, and overall quality.
10. Lead, mentor, and provide substantive scientific and regulatory oversight to Principal and Senior Medical Writers; assign work appropriate to writer expertise and provide actionable feedback.
11. Provide technical direction when project teams encounter complex scientific, regulatory, or writing issues.
12. Serve as an escalation point for high-risk or technically complex projects.
13. Work directly with client regulatory, clinical, biostatistics, safety, quality, and medical teams.
14. Lead client discussions involving regulatory strategy, document development, review resolution, regulatory updates, and submission readiness.
15. Translate regulatory changes into clear, actionable recommendations for clients and internal project teams.
16. Support development and improvement of writing procedures, templates, training materials, and quality standards.
17. Support business development activities by providing technical expertise during proposals, capability discussions, and prospective client meetings.
18. Own or actively support writer allocation, capacity planning, project estimates, and identification of appropriate resources for pharmaceutical and medical device engagements.
19. Maintain awareness of evolving medical device and pharmaceutical regulatory requirements and communicate relevant changes to clients and internal teams.

Minimum Qualifications

1. Bachelor's degree or higher in life sciences, medicine, pharmacy, biomedical sciences, engineering, or another relevant scientific discipline.
2. 5+ years of medical device regulatory or clinical writing experience, including substantive CER authorship.
3. 5+ years independently leading end-to-end CER projects, including substantial EU MDR CER work from 2019 to the present and direct experience resolving Notified Body questions.
4. 8+ years of pharmaceutical or biologic regulatory medical writing experience, including substantial hands-on authorship and leadership of complex submission documents.
5. Demonstrated end-to-end leadership of a significant pharmaceutical submission program or major clinical submission workstream, with personal authorship of major regulatory documents.
6. Demonstrated experience working with eCTD-based pharmaceutical submissions.
7. Experience substantially contributing to U.S. medical device regulatory submissions; direct 510(k) authorship is strongly preferred.
8. Demonstrated experience developing regulatory strategies for medical device and/or pharmaceutical programs.
9. Demonstrated ability to interpret regulatory updates and provide clear guidance to clients regarding resulting actions or documentation requirements.
10. Demonstrated ability to independently lead complex pharmaceutical medical writing projects and manage multidisciplinary review teams.
11. Experience interacting directly with clients and senior stakeholders.
12. Demonstrated ability to review and provide substantive scientific and regulatory feedback on the work of other senior medical writers.

Preferred Qualifications

1. 12+ years of total pharmaceutical, biologic, and medical device regulatory medical writing experience.
2. Previous Director, Associate Director, Senior Manager, Principal Medical Writer, Regulatory Writing Lead, or comparable senior-level experience.
3. Advanced scientific degree such as MS, PharmD, PhD, MD, or equivalent.
4. Experience across both U.S. and EU regulatory environments.
5. Experience with EU MDR remediation or transition projects.
6. Experience responding directly to Notified Body questions.
7. Experience leading NDA/BLA submission programs and integrated clinical submission workstreams.
8. Experience with eCTD Modules 2 through 5.
9. Experience leading multidisciplinary submission teams.
10. Experience advising clients on evolving FDA, EU MDR, MDCG, ICH, or other regulatory requirements.
11. Leadership experience in a medical writing consultancy or CRO supporting multiple external pharmaceutical clients.