Associate Director, Medical Writing

Encoded Therapeutics Inc.

. Own and manage assigned clinical, regulatory, and preclinical deliverables supporting Encoded’s programs.

Posted 9/26/2026full-timeRemote • United StatesSenior💰 $160,000 - $210,000 per yearWebsite

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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