Director – Medical Writing

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Liquidia Corporation

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2004

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75M Post IPO equity on 2024-02

Biotechnology • Pharmaceuticals

Liquidia is a biopharmaceutical company focused on developing inhaled therapies for rare cardiopulmonary diseases, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company leverages its proprietary PRINT® particle engineering technology to create proprietary formulations and delivery methods aimed at improving efficacy, tolerability, and convenience of inhaled medicines; its pipeline includes inhaled treprostinil (commercial product) and clinical-stage candidates such as L606. Liquidia emphasizes patient support, clinical development, and advancing therapies for improved respiratory outcomes.

📋 Description

• 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. • 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. • Partnering 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 • 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. • 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. • 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. • 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

• Bachelor’s degree in life sciences, pharmacy, nursing, or related life sciences filed 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. • 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.

🏖️ Benefits

• Medical • Dental • Vision • STD • LTD • 401(k) Savings Retirement Plan • ESPP • Unlimited Paid Time Off