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Salary: USD 180,000 - 210,000 / annual
Encoded Therapeutics is a biotechnology company advancing precision medicines for genetic disorders through viral gene therapy. We are seeking an Associate Director of Medical Writing to join our medical writing team, reporting to the Head of Medical Writing.
In this role, you will serve as a scientific and strategic lead responsible for researching, authoring, editing, and managing high-quality clinical and regulatory documents in support of our programs. You will work across Clinical Development, Regulatory Affairs, Quality, Biometrics, Medical Affairs, Commercial, CMC, Nonclinical Development, and executive leadership to interpret data, formulate key messaging, and drive regulatory and clinical document development.
Key responsibilities include:
- Own and manage assigned clinical, regulatory, and preclinical deliverables including clinical study protocols, Investigator Brochures, clinical study reports, IND submissions, BLA/MAA components, and safety updates
- Partner with cross-functional teams to analyze and interpret clinical data from internal and external sources, translating findings into clear, scientifically accurate content
- Contribute medical writing expertise to shape document strategy, organization, and messaging across assigned deliverables
- Support development and implementation of scalable medical writing infrastructure including templates, processes, standards, style guides, and QC practices
- Develop realistic timelines for deliverables, manage multiple writing projects in parallel, and coordinate workload with the Head of Medical Writing
- Collaborate with internal and external authors, vendors, and clinical investigators to support document development and track milestones
- Coordinate review cycles and incorporate stakeholder feedback to produce final deliverables that are high quality, scientifically accurate, and compliant
- Ensure document content, format, and style adhere to company standards and regulatory requirements (ICH, FDA, EMA)
- Review Statistical Analysis Plans and Tables, Figures, and Listings to support appropriate data presentation
- Develop and maintain scientific, medical, regulatory, and technical knowledge relevant to our pipeline, gene therapy platform, and disease areas
Requirements:
- Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred with minimum 5+ years of biopharmaceutical or scientific, medical, or regulatory experience; OR Master's degree with 8+ years; OR Bachelor's degree in molecular biology, genetics, or related scientific discipline with 12+ years of relevant experience
- Prior work experience at a biotech or pharmaceutical company preferred; experience in smaller company or rare disease environment ideal
- Multiple contributions to BLA/NDA submissions preferred
- Strong background and track record of producing high-quality scientific and medical documents for internal and external distribution
- Ability to work, communicate, and collaborate with colleagues and external stakeholders as a team player with transparency in a data-driven, fast-paced environment
- Capability to prioritize multiple projects and deliverables, exercise thoughtful judgment, and apply strong problem-solving and decision-making skills
- Ability to identify opportunities for change and improvement with emphasis on operations and efficiency
- Exceptional computer skills and familiarity with Microsoft Office, Adobe, SharePoint, GraphPad, and other document creation and cloud-based programs
