We are seeking an experienced Associate Director, Medical Writing to provide strategic leadership and scientific expertise across the development of high-quality clinical and regulatory documents supporting a diverse portfolio of investigational and marketed therapies. This role will be responsible for leading medical writing activities across multiple development programs, ensuring that all documentation is scientifically accurate, compliant with global regulatory requirements, and aligned with corporate objectives.
The Associate Director will serve as a key cross‑functional partner, collaborating closely with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, Medical Affairs, and external vendors to drive timely delivery of critical regulatory and scientific documents. The ideal candidate possesses extensive regulatory writing experience within the pharmaceutical or biotechnology industry and demonstrates strong leadership, project management, and communication skills.
Key Responsibilities
Medical Writing Leadership
- Lead the preparation, review, and finalization of complex clinical and regulatory documents across all phases of development.
- Provide strategic oversight for medical writing activities supporting multiple programs and submissions.
- Establish document strategies, timelines, and resource plans to ensure high‑quality deliverables.
- Serve as the medical writing subject matter expert on cross‑functional project teams.
Regulatory Documentation
- Author and oversee the development of:
- Clinical Study Reports (CSRs)
- Clinical Study Protocols and Protocol Amendments
- Common Technical Document (CTD) modules
- Integrated Summaries of Safety (ISS) and Efficacy (ISE)
- Briefing books and regulatory response documents
- Pediatric Study Plans and other global regulatory submissions
- Ensure documents meet FDA, EMA, ICH, and other applicable regulatory requirements and guidelines.
Cross‑Functional Collaboration
- Partner with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Safety, and Medical Affairs teams to gather, interpret, and synthesize complex scientific information.
- Facilitate document review cycles and drive alignment among stakeholders.
- Participate in submission planning and regulatory strategy discussions.
- Coordinate contributions from internal teams and external vendors to ensure consistency and quality.
Quality and Compliance
- Ensure all documents are scientifically accurate, well organized, and compliant with internal standards and regulatory expectations.
- Maintain inspection‑ready documentation and support regulatory agency interactions as needed.
- Contribute to the development and implementation of medical writing processes, templates, and best practices.
- Review and approve deliverables prepared by contract writers and vendors.
People Leadership and Mentorship
- Mentor and provide guidance to junior and senior medical writers.
- Support workload planning, resource allocation, and vendor oversight.
- Foster a culture of quality, collaboration, and continuous improvement within the medical writing function.
- Contribute to talent development and departmental initiatives.
Qualifications
Education
- Advanced degree (PhD, PharmD, MD, MS, MPH, or equivalent) in a life sciences, medical, pharmacy, or related discipline preferred.
- Bachelor’s degree with significant relevant experience will also be considered.
Experience
- 8+ years of medical writing experience within the pharmaceutical, biotechnology, or CRO industry.
- Demonstrated experience authoring and leading major regulatory submission documents.
- Experience supporting programs across multiple phases of clinical development.
- Prior experience in CNS, neuroscience, psychiatry, addiction medicine, or other specialty therapeutic areas is preferred.
Technical Skills
- Strong knowledge of global regulatory requirements, including ICH, FDA, and EMA guidance.
- Expertise in preparing clinical and regulatory documents for health authority submissions.
- Ability to interpret and communicate complex clinical, scientific, and statistical data.
- Familiarity with electronic document management systems and submission processes.
- Exceptional scientific writing and editing skills.
- Strong leadership and project management capabilities.
- Excellent organizational skills and ability to manage multiple priorities simultaneously.
- Strong interpersonal and communication skills with the ability to influence cross‑functional teams.
- Detail‑oriented with a commitment to quality and regulatory compliance.
- Ability to work effectively in a fast‑paced, collaborative environment.
Preferred Qualifications
- Experience supporting NDA, BLA, MAA, or supplemental regulatory submissions.
- Experience managing external medical writing vendors and consultants.
- Track record of successful interactions supporting regulatory agency submissions and responses.
- Experience contributing to process optimization and departmental strategy.
What You’ll Bring
You will bring a deep understanding of clinical development and regulatory documentation, a passion for scientific communication, and the leadership skills necessary to drive high‑quality medical writing deliverables. In this role, you will help transform complex clinical data into clear, compelling, and compliant documents that support the advancement of innovative therapies and successful regulatory outcomes worldwide.
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