Liquidia Corporation

Medical Director

• Lead medical writing strategy for assigned development programs across all product-development stages
• Serve as primary medical writing representative on cross-functional project teams
• Develop document plans, timelines, and resource strategies supporting regulatory milestones and corporate objectives
• Provide strategic input on document content, messaging, regulatory positioning, and submission readiness
• Ensure consistency of scientific messaging across regulatory submissions and health authority interactions
• Contribute to regulatory and development strategies through communication of clinical and scientific data
• Lead planning, authoring, coordination, review, and finalization of clinical development documents, including protocols, investigator brochures, CSRs, clinical development plans, statistical analysis plan summaries, clinical overviews, ISS, ISE, synopses, and executive summaries
• Partner with regulatory leads and subject matter experts to develop INDs, CTAs, NDAs, BLAs, MAAs, supplements, briefing materials, Module 2 documents, orphan drug applications, expedited pathway applications, Pediatric Study Plans, and Pediatric Investigation Plans
• Lead major global submissions, not only individual documents within a major application
• Ensure documents comply with ICH, GCP, CTD, and applicable regulatory guidance
• Establish and maintain document standards, templates, style guides, and best practices
• Ensure quality control and consistency across documents and programs
• Support inspection readiness and document audits
• Monitor evolving regulatory expectations and industry standards
• Manage external medical writing vendors and consultants
• Oversee outsourced writing activities, quality, timelines, and budgets
• Review and approve vendor-generated deliverables
• Support vendor selection and performance management
• Mentor and develop internal medical writers when applicable
• Contribute to departmental strategic planning and organizational growth
• Lead process improvement initiatives and implementation of best practices
• Participate in hiring, performance management, and talent development
• Serve as a subject matter expert for medical writing and regulatory document development

Senior Director, Medical Writing