Associate Director, Medical Writing – Clinical and Regulatory

🕒 September 26

🇺🇸 United States – Remote

💵 $170k - $210k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 24%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 47 days.
• Jobs at this company usually fill in 21 days.
• Reposted once.

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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 in support of Encoded’s programs. • 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 shape document strategy, organization, and messaging. • Support scalable medical and scientific writing infrastructure, including templates, processes, standards, style guides, workflows, operating procedures, document QC practices, publishing readiness, and editing standards. • Develop timelines, manage multiple writing projects in parallel, communicate risks or resource needs, and coordinate workload with the Head of Medical Writing. • Collaborate with internal and external authors, vendors, service providers, and clinical investigators. • Coordinate review cycles and incorporate or adjudicate stakeholder comments to produce compliant, high-quality final deliverables. • Ensure content, format, and style comply with company standards, regulatory requirements, ICH, FDA, EMA, and other applicable guidelines. • Review Statistical Analysis Plans and Tables, Figures, and Listings to support appropriate data presentation. • Maintain scientific, medical, regulatory, and technical knowledge relevant to Encoded’s 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

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