Associate Director, Medical Writing

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $160k - $210k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Encoded Therapeutics Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Encoded Therapeutics Inc. is a biotechnology company focused on developing innovative genetic medicines to address central nervous system (CNS) disorders. Their work aims to tackle the root causes of these disorders, providing potentially transformative, long-lasting therapies designed to improve patient outcomes and quality of life, particularly for conditions such as Dravet Syndrome and Angelman Syndrome. The company uses a unique targeting and regulation platform allowing for increased gene specificity and cell selectivity, overcoming challenges associated with first-generation gene therapies. Encoded Therapeutics is dedicated to translating cutting-edge science into practical, life-changing solutions for patients worldwide.

📋 Description

• 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

• 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

• 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