Director/Sr. Director, Medical Writing

Job Summary

Liquidia is dedicated to bringing novel therapies to patients and healthcare providers. Our focus is on improving the treatment of pulmonary arterial hypertension (PAH) using our proprietary PRINT Technology. We seek a Director/Senior Director, Medical Writing to lead the development of regulatory and clinical documents from early clinical development through registration and lifecycle management.

Job Responsibilities

Medical Writing Leadership and Strategy:

• Lead the medical writing strategy for assigned development programs.
• 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 various clinical development documents including, but not limited to:
  • 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)
  • Integrated summaries of efficacy (ISE)
  • Synopses and executive summaries
• Ensure documents are scientifically accurate, data-driven, and compliant with applicable ICH, FDA, EMA, PMDA, NMPA, and other global requirements.
• Partner with the regulatory lead and applicable Subject Matter Experts, lead development of regulatory submission documents including, but not limited to:
  • 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, Pediatric Investigation Plans

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.
• Support inspection readiness and document audit activities.
• Maintain awareness of evolving regulatory expectations and industry standards.

Vendor and Resource Management (Sr Director):

• 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 (Sr Director):

• When applicable, mentor and develop internal medical writers.
• Contribute to departmental strategic planning and organizational growth.
• Lead process improvement initiatives and implementation of best practices.
• Serve as a subject matter expert for medical writing and regulatory document development across the organization.

Job Requirements

Education and Experience:

• Bachelor’s degree in life sciences, pharmacy, nursing, or related life sciences field required.
• Minimum 10 (Director) -12 years (Senior Director) of experience with significant focus in medical writing within biotechnology, pharmaceutical, CRO, or related environment.
• Proven experience and knowledge in leading and executing medical writing strategy and execution in a fast-paced bio-pharma landscape.
• Experience managing medical writing teams and/or external vendors preferred (for Senior Director).

Knowledge, Skills, and Abilities:

• 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.
• Technical Competencies: Strong data interpretation and synthesis skills, excellent critical thinking and problem-solving abilities, ability to identify data gaps and develop scientifically sound messaging strategies, compelling interpersonal verbal, written and presentation skills, strong management and organizational skills, ability to prioritize and accelerate multiple programs and projects, high degree of independence, integrity, sound judgement and commitment to compliance, 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.

Job Benefits

Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more! Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position. Recruiting Agencies, Please Note: Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.