Director, Regulatory Document Quality Control

Leads a group of regulatory document quality control specialists to ensure content accuracy, consistency of information, and appropriateness of source documentation for multiple types of documents for regulatory submission. Examples include clinical and nonclinical CTD Module 2 summaries, briefing documents, protocols, investigator brochures, clinical study reports (CSRs), and other types of cross-functional documents and reports. Requires knowledge of product areas and current developments.