Executive Director, Medical Writing

Role Summary

Executive Director, Medical Writing responsible for establishing and managing the Cardiorenal Medical Writing group within BridgeBio, overseeing development and finalization of clinical and regulatory documents, and guiding internal and external Medical Writers to deliver high-quality submissions and disclosures in regulatory programs.

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, amendments, CSRs, investigator brochures, and related documents
• Provide strategic leadership to study teams for preparation of protocols, CSRs, submissions, and public disclosure documents
• Lead medical writing for regulatory submissions including INDs, NDA/MAA data modules, Briefing Documents, and related documentation for marketing authorization or label expansion
• Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements
• Ensure SOPs related to document development conform with regulatory requirements and guide teams through these processes
• Partner with clinical development, biostatistics, and data management in reviewing data presentations and narrative planning
• Work with study teams to ensure results in clinical documents accurately reflect data
• Project manage the document review process, resolving conflicts and addressing comments in a timely manner
• Ensure documents are submission-ready and archived in the document management system
• Perform quality control checks on deliverables, respond to findings, and implement quality improvements
• Establish Medical Writing support models and implement strategies to improve efficiency and productivity; oversee vendor management as needed

Qualifications

• Post-graduate scientific or medical degree (e.g., MS, MPH, PhD, PharmD, MD, DO) with 10+ years of regulatory medical writing experience in biotech/pharmaceuticals
• Experience in medical writing for multiple regulatory filings at various development stages
• Experience managing consultants and their projects
• Excellent oral and written communication skills with the ability to summarize complex scientific data clearly
• Proficient in drug development processes with strong understanding of health authority regulations and ICH guidelines
• Strong interpersonal, listening, and influencing skills
• Strong project management skills; able to work independently, multi-task, and perform under pressure
• Experience with EndNote, StartingPoint templates, and Veeva Vault is preferred

Skills

• Strategic leadership in medical writing
• Regulatory writing and data disclosure proficiency
• Cross-functional collaboration with clinical development, biostatistics, and data management
• Document development standards, SOPs, and quality control processes
• Vendor management and process improvements