Director/Sr. Director, Medical Writing

Liquidia•,

12h

About The Position

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 and 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), and Common Technical Document (CTD) Module 2 summaries supporting INDs, NDAs, BLAs, MAAs, and lifecycle submissions.

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.
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).
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.

Nice To Haves

Senior Director: Experience managing medical writing teams and/or external vendors preferred.
Familiarity or experience working with VEEVA RIM, Starting Point templates, EndNote, and other technical tools to support document efficiency and quality.
Senior Director: Demonstrated experience leading major global submissions (not just individual documents within a major application).

Responsibilities

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.