Associate Director, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership and oversee assigned clinical, regulatory, and preclinical deliverables that support Encoded’s initiatives.

• Conduct research, draft, edit, and manage clinical and regulatory documents, which include protocols, Investigator Brochures, clinical study reports, INDs/CTDs, BLAs, amendments, plans, safety updates, narratives, summaries, and briefing materials.

• Collaborate with cross-functional teams to analyze and interpret clinical data, translating findings into scientifically accurate content, conclusions, and key messages.

• Execute literature and scientific database searches to facilitate analyses and background summaries.

• Apply medical writing expertise to enhance document strategy, organization, messaging, consistency, efficiency, and clarity.

• Design and implement a medical and scientific writing infrastructure that includes templates, processes, standards, style guides, workflows, operating procedures, quality control practices, publishing readiness, and editing standards.

• Develop timelines, manage multiple writing projects, communicate risks or resource requirements, and coordinate workload with the Head of Medical Writing.

• Work with authors, vendors, service providers, and clinical investigators to support document development and monitor milestones.

• Organize review cycles, resolve comments, and deliver high-quality, scientifically accurate, compliant final products.

• Ensure that documents comply with company standards, style guides, and ICH, FDA, EMA, and other regulatory requirements.

• Review Statistical Analysis Plans and Tables, Figures, and Listings, providing feedback on data presentation.

• Stay updated on scientific, medical, regulatory, and technical knowledge pertinent to the pipeline, gene therapy platform, clinical studies, and disease areas.

⛳️ Requirements

• An advanced scientific degree (PhD, PharmD, MD, or equivalent) is preferred, with at least 5+ years of experience in biopharmaceutical or scientific, medical, or regulatory roles; or a Master’s degree with 8+ years; or a Bachelor’s degree in molecular biology, genetics, or a related scientific field with 12+ years of relevant experience.

• Previous experience in a biotech or pharmaceutical company is preferred; experience in a smaller company or rare disease environment is ideal.

• Candidates with multiple contributions to BLA/NDA submissions are preferred.

• A solid background and proven record of producing high-quality scientific and medical documents for both internal and external audiences is essential.

• Must possess the ability to work, communicate, and collaborate with colleagues and external stakeholders as a team player, demonstrating transparency in a data-driven, fast-paced, and dynamic environment.

• Must be capable and comfortable prioritizing multiple projects, deliverables, and timelines, while exercising sound judgment and applying strong problem-solving and decision-making skills.

• Ability to anticipate and identify opportunities for change and improvement, focusing on operations and efficiency.

• Exceptional computer skills and familiarity with essential 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