Senior Director, Medical Writing
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Job Description
Senior Director leading regulatory and clinical medical writing for Liquidia, a company developing pulmonary arterial hypertension therapies. Guiding global submissions, health authority interactions, and cross-functional document strategy.
Responsibilities:
- 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
Requirements:
- Bachelor’s degree in life sciences, pharmacy, nursing, or related life sciences field required
- Minimum 12 years of experience with significant focus in medical writing within biotechnology, pharmaceutical, CRO, or related environment
- Proven experience and knowledge leading and executing medical writing strategy and execution in a fast-paced biopharma landscape and/or demonstrated movement from large/medium pharma organizations to biotech
- Business travel 10–20% as required
- 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 preparing nonclinical, clinical, and regulatory documents
- Familiarity with regulatory requirements across FDA, EMA, PMDA, MHRA, Health Canada, NMPA, ANVISA, and other major health authorities
- Familiarity or experience with Veeva RIM, Starting Point templates, EndNote, and other technical tools
- 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 communication skills
- Strong management and organizational skills, with ability to prioritize and accelerate multiple programs and projects
- High degree of independence, integrity, sound judgment, 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:
- Competitive compensation package
- Medical insurance
- Dental insurance
- Vision insurance
- Short-term disability (STD)
- Long-term disability (LTD)
- 401(k) Savings Retirement Plan
- Employee Stock Purchase Plan (ESPP)
- Unlimited Paid Time Off (PTO)
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