[Hiring] Associate Director, Medical Writing @Encoded Therapeutics

Role Description

We are seeking a highly motivated medical writer to join our medical writing team as an Associate Director or Senior Manager. Reporting into the Head of Medical Writing, the Associate Director/Senior Manager of Medical Writing (Clinical and Regulatory) serves as a scientific and strategic lead responsible for researching, authoring, editing, and managing high-quality clinical and regulatory documents in support of Encoded’s programs.

Working in partnership with colleagues across various departments, this individual will help interpret data, formulate key messaging, and drive the development of regulatory and clinical documents. These documents include:

• Clinical study protocols and clinical protocol amendments
• Investigator Brochures
• Responses to regulatory authority questions
• Clinical study reports
• Patient narratives
• Clinical development plans
• IND submissions
• Integrated summary reports
• Components of Modules 1 and 2 of BLA/MAA submissions

The role will also support the continued development of medical writing infrastructure and processes, including best practices and resources for document management and timelines, template and shell creation, lexicon and document QC, publishing, and editing standards.

Qualifications

• Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred with a minimum of 5+ years of biopharmaceutical or scientific, medical or regulatory experience
• Master’s degree with 8+ years of experience
• 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 preferred; experience in a smaller company or rare disease environment is ideal
• Writers with multiple contributions to BLA/NDA submissions are preferred
• Strong background and track record of producing high-quality scientific and medical documents for internal and external distribution

Requirements

• Ability to work, communicate, and collaborate with colleagues and external stakeholders as a team player with transparency
• Capability and comfort with prioritizing multiple projects, deliverables, and timelines
• Exceptional computer skills and familiarity with key software and cloud-based programs for document creation (e.g., Microsoft Office, Adobe, etc.)
• Experience with sharing/editing tools (e.g., SharePoint, GraphPad, etc.)

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• 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