Associate Director, Medical Writing
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Job Description
Medical writing leader advancing Encoded Therapeutics’ gene therapy programs and regulatory submissions. Leading clinical documents, data interpretation, cross-functional strategy, and writing infrastructure.
Responsibilities:
- Own and manage assigned clinical, regulatory, and preclinical deliverables supporting Encoded’s programs.
- Research, author, edit, and manage clinical and regulatory documents, including protocols, Investigator Brochures, clinical study reports, INDs/CTDs, BLAs, amendments, plans, safety updates, narratives, summaries, and briefing books.
- Partner with cross-functional teams to analyze and interpret clinical data and translate findings into scientifically accurate content, conclusions, and key messaging.
- Perform literature and scientific database searches to support analyses and background summaries.
- Contribute medical writing expertise to document strategy, organization, messaging, consistency, efficiency, and clarity.
- Develop and implement medical and scientific writing infrastructure, including templates, processes, standards, style guides, workflows, operating procedures, QC practices, publishing readiness, and editing standards.
- Develop timelines, manage multiple writing projects, communicate risks or resource needs, and coordinate workload with the Head of Medical Writing.
- Collaborate with authors, vendors, service providers, and clinical investigators to support document development and track milestones.
- Coordinate review cycles, adjudicate comments, and produce high-quality, scientifically accurate, compliant final deliverables.
- Ensure documents adhere to company standards, style guides, and ICH, FDA, EMA, and other regulatory requirements.
- Review Statistical Analysis Plans and Tables, Figures, and Listings and provide feedback on data presentation.
- Maintain scientific, medical, regulatory, and technical knowledge relevant to the pipeline, gene therapy platform, clinical studies, and disease areas.
Requirements:
- Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred with a minimum of 5+ years of biopharmaceutical or scientific, medical or regulatory experience, or a Master’s degree with 8+ years, or a Bachelor’s degree in molecular biology, genetics, or a related scientific discipline with 12+ years of relevant experience.
- Prior work experience at a biotech or pharmaceutical company is preferred; experience in a smaller company or rare disease environment is ideal.
- Writers with multiple contributions to BLA/NDA submissions are preferred.
- A strong background and track record of producing high-quality scientific and medical documents for internal and external distribution is required.
- Ability to work, communicate, and collaborate with colleagues and external stakeholders as a team player with transparency in a data-driven, fast-paced, and exciting environment.
- Capability and comfort with prioritizing multiple projects, deliverables, and timelines, exercising thoughtful judgment, and applying strong problem-solving and decision-making skills.
- Ability to think ahead and identify opportunities for change and improvement, with an emphasis on operations and efficiency.
- Exceptional computer skills and familiarity with key software and cloud-based programs for document creation (e.g., Microsoft Office, Adobe, etc.) and sharing/editing (e.g., SharePoint, GraphPad, etc.).
Benefits:
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Comprehensive benefits package, including competitive employer premium contributions
- PTO, sick time and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- STD, LTD, Life and AD&D
- Professional development opportunities
- Team-building events
- Fully stocked micro-kitchen
- Fitness center at South San Francisco location
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