Executive Director, Medical Writing

Role Summary

Executive Director, Medical Writing responsible for establishing and managing the Cardiorenal Medical Writing group at BridgeBio, overseeing development and finalization of clinical and regulatory documents, and leading internal and external Medical Writers to produce high-quality submissions and related documents.

Responsibilities

• Oversee the Cardiorenal Medical Writing group, including leading, training, and mentoring for effective performance
• Lead medical writing from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related documents
• Provide strategic leadership to study teams to direct preparation of protocols, CSRs, submissions, and associated public disclosure documents
• Lead medical writing for regulatory submissions including IND applications, briefing documents, NDA/MAA data modules, and submission packages
• Demonstrate knowledge of regulatory writing and data disclosure requirements
• Ensure SOPs related to document development conform with regulatory requirements; own processes and guide teams
• Partner with clinical development, biostatistics, and data management in the review of TFLs and case narrative planning
• Work with study teams to ensure results/messages reflect data accurately; align documents with data sources
• Project manage the document review process, resolve conflicting comments, and ensure timely completion
• Ensure documents are submission-ready and archived in the document management system
• Ensure QC checks are performed on deliverables and drive quality improvements
• Establish Medical Writing support models and improve efficiency; oversee vendor management as needed

Qualifications

• Post-graduate scientific or medical degree (e.g., MS, MPH, PhD, PharmD, MD, DO) with 10+ years of experience as a regulatory medical writer in biotech/pharma
• Experience with medical writing for multiple regulatory filings across development stages
• Experience managing consultants and projects
• Excellent oral and written communication skills; ability to summarize complex data clearly
• Strong understanding of drug development process, health authority regulations, ICH guidelines, and medical writing standards
• Excellent interpersonal, listening, and influencing skills
• Strong project management, independent work, multi-tasking, and ability to perform under pressure
• Experience with EndNote, StartingPoint templates, and Veeva Vault preferred

Skills

• Regulatory writing and data disclosure expertise
• Leadership and people management
• Strategic planning for documentation and submissions
• Cross-functional collaboration (clinical development, biostatistics, data management)
• Vendor management and process optimization