Senior Director, Pharmaceutical and Medical Device Writing Services

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🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

✏️ Content Writer

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Criterion Edge

WebsiteLinkedInAll Job Openings

11 - 50 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success for Medical Device, Pharma, and In Vitro Diagnostics companies through expert regulatory, scientific, and clinical writing services. With a team of seasoned regulatory writers and medical librarians, Criterion Edge collaborates with its clients to produce high-quality, compliant documentation that meets global regulatory standards and accelerates approval timelines.

📋 Description

• Lead Criterion Edge’s Pharmaceutical Writing Services group with accountability for technical quality, delivery, staff development, and pharmaceutical and biologic regulatory writing engagements • Provide scientific, technical, and operational leadership for pharmaceutical writing engagements and complex clinical submission programs • Maintain direct authorship and critical review responsibility for complex pharmaceutical and medical device documents • Independently lead end-to-end EU MDR Clinical Evaluation Report projects, including Notified Body deficiency responses • Establish pharmaceutical writing processes, quality expectations, and technical review standards • Lead client scoping discussions, proposal input, kickoffs, and senior-level client communications • Develop and communicate regulatory and medical writing strategies • Advise clients on regulatory updates, changing requirements, emerging guidance, submission expectations, and documentation impacts • Plan deliverables, budgets, timelines, resources, and cross-functional review cycles; oversee execution and address delivery risks • Independently author or lead pharmaceutical regulatory documents and major submission workstreams • Review scientific and regulatory documents for accuracy, compliance, consistency, and quality • Lead, mentor, and provide substantive oversight to Principal and Senior Medical Writers • Provide technical direction and serve as an escalation point for complex or high-risk projects • Collaborate directly with client regulatory, clinical, biostatistics, safety, quality, and medical teams • Translate regulatory changes into actionable recommendations • Support writing procedures, templates, training materials, and quality standards • Support business development through proposals, capability discussions, and prospective client meetings • Support writer allocation, capacity planning, project estimates, and resource identification • Maintain awareness of evolving pharmaceutical and medical device regulatory requirements and communicate relevant changes

🎯 Requirements

• Bachelor's degree or higher in life sciences, medicine, pharmacy, biomedical sciences, engineering, or another relevant scientific discipline • At least 8 years of direct pharmaceutical and/or biologic regulatory medical writing experience • At least 5 years of direct medical device regulatory or clinical writing experience • At least 5 years independently leading end-to-end CER projects, including substantial EU MDR CER work from 2019 to the present • Direct experience resolving Notified Body questions • Substantial hands-on authorship and leadership of complex pharmaceutical and biologic submission documents • End-to-end leadership of significant pharmaceutical submission programs or major clinical submission workstreams • Experience with eCTD-based pharmaceutical submissions, including eCTD Modules 2 through 5 • Substantial CER authorship and ability to independently scope, author, lead, and finalize regulator-ready CERs • Current working knowledge of EU MDR clinical evaluation requirements, MEDDEV 2.7/1 Rev. 4, and applicable MDCG guidance • Demonstrated ability to develop regulatory strategies for medical device and/or pharmaceutical programs • Ability to interpret regulatory updates and provide clear guidance to clients • Ability to independently lead complex pharmaceutical medical writing projects and multidisciplinary review teams • Experience interacting directly with clients and senior stakeholders • Ability to review and provide substantive scientific and regulatory feedback on other senior medical writers' work • Experience substantially contributing to U.S. medical device regulatory submissions; direct 510(k) authorship strongly preferred • Experience developing pharmaceutical and medical device writing strategies and advising on regulatory guidance and submission expectations • Preferred: 12+ years of total pharmaceutical, biologic, and medical device regulatory medical writing experience • Preferred: previous Director, Associate Director, Senior Manager, Principal Medical Writer, Regulatory Writing Lead, or comparable senior-level experience • Preferred: advanced scientific degree such as MS, PharmD, PhD, MD, or equivalent • Preferred: experience across U.S. and EU regulatory environments, EU MDR remediation or transition projects, NDA/BLA submission programs, multidisciplinary submission teams, and consultancy or CRO environments

🏖️ Benefits

• Remote work arrangement • Professional development and writer development opportunities • Mentorship and substantive scientific and regulatory oversight • Opportunity to work on complex pharmaceutical, biologic, and medical device regulatory engagements • Senior-level client and stakeholder exposure • Potential for expedited interview review for properly completed applications

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