Associate Director, Medical Writing (Clinical and Regulatory)

About the role

Encoded Therapeutics, a biotechnology company focused on viral gene therapy for genetic disorders, is looking for an Associate Director (or Senior Manager) of Medical Writing, reporting to the Head of Medical Writing. The role leads the research, authoring, editing and management of high-quality clinical and regulatory documents, working with Clinical Development, Regulatory Affairs, Quality, Biometrics, Medical Affairs, Commercial, CMC and Nonclinical Development. The workplace is remote.

Key responsibilities

• Own and manage clinical, regulatory and preclinical deliverables such as protocols, Investigator Brochures, clinical study reports, BLA/IND documents, safety updates, narratives and briefing books.
• Partner with cross-functional teams to interpret clinical data and turn findings into clear, scientifically accurate content and key messaging, including literature searches.
• Help shape document strategy, organization and messaging, and build scalable writing infrastructure: templates, shells, style guides, workflows, QC practices and editing standards.
• Set realistic timelines, run multiple projects in parallel, manage risks and coordinate workload with the Head of Medical Writing.
• Work with internal and external authors, vendors and investigators, and coordinate review cycles so final documents are compliant and aligned to agreed messages.
• Ensure documents follow company standards, style guides and regulatory requirements (ICH, FDA, EMA).
• Review statistical tables, figures and listings for clinical study reports and keep up with the company's pipeline and gene therapy platform.

Required profile

• Advanced degree (PhD, PharmD, MD or equivalent) preferred with 5+ years of biopharma or scientific/regulatory experience, or a Master's with 8+ years, or a Bachelor's in molecular biology, genetics or a related field with 12+ years.
• Prior experience at a biotech or pharma company preferred; smaller company or rare disease experience ideal.
• Multiple contributions to BLA/NDA submissions preferred.
• Strong track record of high-quality scientific and medical documents for internal and external use.

Required skills

• Exceptional computer skills and familiarity with document creation tools (Microsoft Office, Adobe) and sharing/editing platforms (SharePoint, GraphPad).
• Ability to prioritize multiple projects, solve problems and work in a fast-paced, data-driven environment.

What we offer

• Salary of $180,000-$210,000 for SF Bay Area candidates, $170,000-$195,000 elsewhere.
• Comprehensive benefits with competitive employer premium contributions, PTO, sick time, holiday pay and parental leave.
• Stock options, pre-tax medical and dependent care programs, STD/LTD/Life/AD&D insurance and professional development.
• Team-building events, a fully stocked micro-kitchen and a fitness center at the South San Francisco location.