Director, Medical Writing

About the Role

Septerna is seeking an experienced and motivated Director of Medical Writing to lead the development and execution of medical writing activities across our clinical programs. This individual will be responsible for producing high-quality clinical and regulatory documents that support global submissions and ensure clear, accurate, and compliant communication of scientific and clinical data. The ideal candidate will be a hands-on leader who thrives in a fast-paced, growing biotech environment and enjoys collaborating across functions to deliver high-impact results. This position reports into the VP, Regulatory Affairs.

Responsibilities

• Lead the medical writing function and establish best practices, processes, and standards to support clinical and regulatory documentation.


• Author, review, and manage the development of clinical and regulatory documents, including protocols, investigator brochures, clinical study reports (CSRs), INDs, CTAs, briefing packages, and clinical sections of regulatory submissions.


• Collaborate closely with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Nonclinical teams to ensure accuracy, consistency, and alignment across documents.


• Serve as the medical writing lead on cross-functional project teams, ensuring deliverables meet timelines and quality standards.


• Oversee external medical writing vendors and contractors, ensuring consistency with Septerna’s quality and style guidelines.


• Contribute to regulatory submission planning and authoring strategy, including preparation for agency interactions.


• Support publication planning and development, including abstracts, posters, and manuscripts as needed.


• Mentor and provide strategic direction to team members as the company grows. 

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree (PhD, PharmD, or MS) preferred.


• Prior managerial experience (including consultants) preferred.


• 10+ years of medical writing experience in the biopharmaceutical industry, with a focus on clinical and regulatory documents.


• Proven experience authoring and managing documents supporting INDs, CTAs, and other regulatory submissions.


• Proficient in the drug development process with a deep understanding of ICH, FDA, and EMA guidelines and requirements.


• Exceptional attention to detail, organization, and scientific accuracy.The ability to summarize and present complex scientific and clinical data effectively.


• Strong leadership, problem-solving, communication, and cross-functional collaboration skills.


• Ability to manage multiple projects and priorities in a dynamic, fast-paced environment.


• Comfortable working hands-on while also building scalable infrastructure for future growth.