Demonstrated ability to develop endpoint and regulatory strategy for assigned projects by applying regulatory guidance and precedent to evidence plans (e.g., study design), regulatory interaction support (e.g., correspondence, meeting materials), and regulatory documentation (e.g., briefing books, dossiers), escalating complex or novel issues as needed. Quality & Scientific Integrity: Conducts senior-level review of analyses, data interpretations, and client deliverables to ensure they meet scientific integrity, accuracy, and alignment to scope and intended use, and ensures projects are conducted in compliance with the PCO Quality Management System and applicable SOPs.