Associate Director, Medical Writing (Clinical and Regulatory)

Encoded-Therapeutics,-Inc.; United States; Vor Ort; USD 170.000 - 210.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits package

Stock options

PTO, sick time and holidays

Generous parental leave

Pre-tax medical and dependent care

Zusammenfassung

Encoded Therapeutics Inc. seeks an Associate Director/Senior Manager of Medical Writing (Clinical and Regulatory) to lead the preparation and oversight of complex regulatory and clinical documents.

You will shape strategy, coordinate timelines, and ensure high-quality outputs across multiple programs. You will collaborate with Clinical Development, Regulatory, Quality, Biostatistics, and Medical Affairs to translate data into clear, compliant content for INDs, BLAs, and MAAs, while advancing

Qualifikationen

• Advanced scientific degree with 5+ years in biopharma or regulatory writing; or Master’s with 8+ years; or Bachelor’s with 12+ years.
• Experience producing BLA/NDA level documents for internal/external distribution.
• Ability to lead cross-functional teams and communicate data-driven content clearly.

Aufgaben

• Own clinical, regulatory, and preclinical deliverables such as protocols, CSRs, amendments, and sections of BLAs/NDAs.
• Translate clinical data into scientifically accurate content and key messaging.
• Develop scalable medical writing infrastructure, templates, and style guides.
• Coordinate timelines, manage multiple projects, and communicate risks.
• Collaborate with authors, vendors, and investigators to finalize deliverables.

Kenntnisse

Scientific writing

Cross-functional collaboration

Regulatory strategy

Project management

Communication

Ausbildung

PhD/MD/PharmD or equivalent

Master's degree in a related field

Bachelor’s in molecular biology/genetics or related

Tools

Microsoft Office

Adobe Acrobat

SharePoint

GraphPad

Jobbeschreibung

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

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 Clinical Development, Regulatory Affairs, Quality, Biometrics, Medical Affairs, Commercial, CMC, Nonclinical Development, and executive leadership, 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, and 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.

Responsibilities

• Own and manage assigned clinical, regulatory, and preclinical deliverables in support of Encoded’s programs. Documents may include clinical study protocols; Investigator Brochures; clinical study reports; components of Modules 1, 2, and 5 of BLAs; INDs/CTDs and amendments; analysis and development plans; safety updates and annual reports; narratives and summaries; briefing books; and other key program documents.
• Partner with cross-functional teams to analyze and interpret clinical data, including internal and external data sources, and translate findings into clear, scientifically accurate content, conclusions, and key messaging; perform literature and scientific database searches as needed to support analyses and background summaries.
• Contribute medical writing expertise on cross-functional teams, helping shape document strategy, organization, and messaging while supporting consistency, efficiency, and clarity across assigned deliverables.
• Support the development and implementation of scalable medical and scientific writing infrastructure, including templates, shells, processes, standards, style guides, workflows, operating procedures, document QC practices, publishing readiness, and editing standards.
• Develop realistic timelines for assigned deliverables in collaboration with cross-functional teams, manage multiple writing projects in parallel, communicate risks or resource needs, and coordinate workload with the Head of Medical Writing to meet program goals.
• Collaborate with internal and external authors, vendors, service providers, and clinical investigators to support document development, align on expectations, and track milestones and deliverables.
• Coordinate review cycles and incorporate or adjudicate comments from internal and external stakeholders, producing final deliverables that are high quality, scientifically accurate, compliant, and aligned to agreed key messages.
• Ensure document content, format, and style adhere to applicable company standards, style guides, and regulatory requirements, including ICH, FDA, EMA, and other appropriate guidelines.
• Review Statistical Analysis Plans and Tables, Figures, and Listings to support appropriate data presentation for clinical study reports and other regulatory documents; provide feedback to project teams as needed.
• Develop and maintain scientific, medical, regulatory, and technical knowledge relevant to Encoded’s pipeline, gene therapy platform, clinical studies, and disease areas.

• 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.).

For candidates based in the SFBA area, the salary range for this position is 180,000 - 210,000

For candidates based outside the SFBA area, the salary range is 170,000 - 195,000

Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location. Actual compensation will be determined based on relevant skills, experience, qualifications, internal equity, and business needs. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

• 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

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

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