Director, Regulatory & Medical Writing (Remote Eligible)

Role Summary The Director, Regulatory & Medical Writing is responsible for strategically managing medical writing resources to support Denali’s development programs and ensuring the timely delivery of high-quality regulatory documents and publications. This leadership role oversees regulatory document development processes, continuously improves those processes, and serves as a key partner to various functions within Development at Denali. Key Responsibilities Develop and execute a resource plan (using both internal and external resources) to support medical writing and editing efforts for all Denali‑developed regulatory documents. Manage and continuously improve Denali’s regulatory document development process. Support Development authors to ensure efficient creation of high‑quality regulatory documents while meeting agreed‑to development timelines. Manage Smartsheet environment and templated timelines for regulatory documents, including reports and dashboards. Establish and maintain cross‑functional relationships to support program goals; persuade and influence internal and external stakeholders. Identify the need for and lead non‑program initiatives and activities. Support the development and maintenance of regulatory document templates and style guides. Maintain up‑to‑date knowledge of regulations and guidelines related to regulatory document structure and content, and GxP quality standards. Participate in relevant industry groups. Qualifications & Skills BS or BA in science/technology or an equivalent combination of education and experience. 10+ years of relevant work experience, including 7+ years of medical writing. Strong working knowledge of regulatory document development standards and best practices. Advanced skills in the use of MS Word and Smartsheet; experience working in SharePoint and Veeva RIM. Excellent communication skills and effective collaboration in a team environment. Ability to work independently and to be innovative in tackling operational challenges. Compensation Salary Range: $211,000.00 to $258,667.00 . Compensation depends on qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401(k), healthcare coverage, ESPP, and a broad range of other benefits. Equal Employment Opportunity Statement Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class. #J-18808-Ljbffr Denali Therapeutics Inc