Sr. Director, Medical Writing

About the role

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, particularly in improving the treatment of pulmonary arterial hypertension (PAH). The Senior Director, Medical Writing provides strategic leadership and scientific expertise in the planning, development, authoring, review, and finalization of high-quality regulatory and clinical documents supporting drug development programs from early clinical development through registration and lifecycle management. This role serves as the lead medical writer for complex regulatory submissions and health authority interactions, ensuring documents are scientifically accurate, strategically aligned, compliant with global regulatory requirements, and delivered on schedule.

The Senior Director partners closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Clinical Pharmacology, Pharmacovigilance, CMC, Quality, and other cross-functional stakeholders to develop critical regulatory documents.

Responsibilities

• Medical Writing Leadership and Strategy:
  • Lead the medical writing strategy for assigned development programs across all stages of product development.
  • Serve as the primary medical writing representative on cross-functional project teams.
  • Develop document plans, timelines, and resource strategies to support regulatory milestones and corporate objectives.
  • Provide strategic input regarding 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 effective communication of clinical and scientific data.
• Clinical Development and Regulatory Submission Documents:
  • Lead the planning, authoring, coordination, review, and finalization of clinical development documents, including:
    • Clinical study protocols and protocol amendments
    • Investigator brochures (IBs)
    • Clinical study reports (CSRs)
    • Clinical development plans
    • Statistical analysis plan summaries
    • Clinical overviews and summaries
    • Integrated summaries of safety (ISS) and efficacy (ISE)
    • Synopses and executive summaries
  • Ensure documents are scientifically accurate, data-driven, and compliant with ICH, FDA, EMA, PMDA, NMPA, and other global requirements.
  • Partner with the regulatory lead and subject matter experts to develop regulatory submission documents, including:
    • INDs and IND amendments
    • CTAs and CTA amendments
    • Documents for NDAs, BLAs, MAAs, and supplements
    • Briefing materials for health authority interactions
    • Nonclinical and Clinical Module 2 documents (2.4-2.7)
    • Orphan drug applications
    • Breakthrough Therapy, Fast Track, and other expedited pathway applications
    • Pediatric Study Plans (PSPs) and Pediatric Investigation Plans (PIPs)
  • Demonstrated experience leading major global submissions.
• Document Quality and Compliance:
  • Ensure all documents comply with ICH, GCP, CTD, and applicable regulatory guidance requirements.
  • 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 audit activities.
  • Maintain awareness of evolving regulatory expectations and industry standards.
• Vendor and Resource Management:
  • 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.
• Leadership and Organizational Development:
  • 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 activities.
  • Serve as a subject matter expert for medical writing and regulatory document development across the organization.

Requirements

• Education and Experience:
  • Bachelor’s degree in life sciences, pharmacy, nursing, or related field required.
  • Minimum 12 years of experience with significant focus in medical writing within biotechnology, pharmaceutical, CRO, or related environment.
  • Proven experience leading and executing medical writing strategy in a fast-paced biopharma landscape.
  • Business travel 10-20% as required.
  • Experience managing medical writing teams and/or external vendors preferred.
• Technical Competencies:
  • Strong understanding of drug development and combination product development.
  • Expert understanding of ICH guidelines, CTD structure, GCP requirements, and global regulatory expectations.
  • Strong expertise in preparing various nonclinical, clinical, and regulatory documents.
  • Familiarity with regulatory requirements across major health authorities (FDA, EMA, PMDA, MHRA, Health Canada, NMPA, ANVISA, etc.).
  • Familiarity or experience working with VEEVA RIM, Starting Point templates, EndNote, and other technical tools to support document efficiency and quality.
• Scientific and Analytical Skills:
  • Ability to interpret and communicate complex clinical, statistical, pharmacological, and scientific information.
  • Strong data interpretation and synthesis skills.
  • Excellent critical thinking and problem-solving abilities.
  • Ability to identify data gaps and develop scientifically sound messaging strategies.
• Leadership and Collaboration:
  • Demonstrated ability to lead cross-functional teams in a matrix environment.
  • Strong stakeholder management and influence skills.
  • Ability to mentor junior staff and provide strategic guidance.
  • Compelling interpersonal, verbal, written, and presentation skills in communication with internal and external stakeholders.
  • Strong management and organizational skills with an ability to prioritize and accelerate multiple programs and projects.
  • High degree of independence, integrity, sound judgment, and commitment to compliance.
• Professional Competencies:
  • Strong attention to detail and commitment to quality.
  • Ability to manage multiple complex projects simultaneously.
  • Demonstrated ability to work effectively under tight timelines and changing priorities.
  • High degree of professionalism, integrity, and accountability.
  • Commitment to continuous learning and process improvement.

Benefits

• Competitive compensation package
• Comprehensive benefits package including:
  • Medical, Dental, Vision
  • Short-Term and Long-Term Disability (STD, LTD)
  • 401(k) Savings Retirement Plan
  • Employee Stock Purchase Plan (ESPP)
  • Unlimited Paid Time Off