Associate Director, Medical Writing (Regulatory)

Corcept is a leading company in the research and development of cortisol modulators, and we are seeking an Associate Director, Medical Writing (Regulatory) to join our team. This role will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions.

Requirements

• Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions
• Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs)
• Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports
• Provide oversight of document quality and consistency for ease of review across multiple documents assembled in a regulatory dossier or briefing package
• Lead document review and comment resolution processes with cross-functional teams
• Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, briefing books and annual reports
• Coordinate the review and approval of documents
• Develop templates, style guidelines, and SOPs for regulatory documentation
• Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements