[Hiring] Director/Senior Director, Medical Writing @Liquidia

Role Description

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary arterial hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

The Director/Senior Director, Medical Writing is responsible for providing 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 Director/Senior Director partners closely with:

• Clinical Development
• Clinical Operations
• Regulatory Affairs
• Biostatistics
• Clinical Pharmacology
• Pharmacovigilance
• CMC
• Quality
• Other cross-functional stakeholders

to develop critical regulatory documents, including:

• Clinical protocols
• Clinical study reports (CSRs)
• Briefing packages for regulatory agencies
• Pediatric Study Plans (PSPs)
• Pediatric Investigation Plans (PIPs)
• Common Technical Document (CTD) Module 2 summaries supporting INDs, NDAs, BLAs, MAAs, and lifecycle submissions

Qualifications

• 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 and/or demonstrated movement from large/medium pharma organizations to biotech.
• Business travel 10-20% as required.
• Senior Director: Experience managing medical writing teams and/or external vendors preferred.

Requirements

• 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.
• 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.
• 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 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.