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 role provides leadership and oversight of regulatory document development processes and continuously improving those processes to enhance efficiency, quality, and consistency across programs. The individual in this role also communicates effectively and persuasively cross-functionally and serves as a key partner to various functions within Development at Denali in support of Denali's product development and company goals.

• Develops and executes on a resource plan (using both internal and external resources) to support medical writing and editing efforts for all Denali-developed regulatory documents
• Manages and continuously improves Denali’s regulatory document development process
• Supports Development authors to ensure efficient development of high-quality regulatory documents while meeting agreed-to document development timelines.
• Manages Smartsheet environment and templated timelines for regulatory documents including reports and dashboards
• Establishes and maintains cross-functional relationships in support of program goals; persuades and influences both internal and external stakeholders.
• Identifies the need for and leads non-program initiatives and activities.
• Supports development and maintenance of regulatory document templates and style guide(s).
• Maintains up-to-date knowledge of the regulations and guidelines related to regulatory document structure and content as well as GxP quality standards.
• Participates in relevant industry groups

• BS or BA in science/technology or an equivalent combination of education and experience
• 10+ years of relevant work experience required, 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 in a collaborative team environment.
• Ability to work independently and to be innovative in tackling operational challenges.