Madrigal Pharmaceuticals

QA Engineer

• Serve as a primary point of contact for the intake and logging of quality events (deviations, change controls, OOS)
• Assist in the initial classification and risk assessment of new events
• Partner with cross-functional teams to facilitate timely investigations and follow-ups in the QMS
• Ensure all relevant documentation is archived in the QDMS in a timely manner
• Track the lifecycle of CAPAs from initiation through closure
• Enter and/or assist others to enter all QEM documentation in a timely fashion
• Assist in compiling, analyzing, and reporting on quality metrics and trends

GMP Quality Assurance Specialist

Director

• support the strategic goals of the GHEOR, Global Medical Affairs (GMA) and broader business driving patient access with optimal pricing and reimbursement for Madrigal Pharmaceutical’s medicines
• develop and execute RWE projects and strategies against global integrated evidence plans
• analyze complex real-world data (RWD)
• design, build, and maintain internal data warehouses
• maintain reproducible analytical pipelines and RWE platforms using R programming
• execute both rapid analyses and full protocol-driven observational studies
• adhere to FDA and EMA regulatory guidance to produce high-quality evidence
• present at scientific conferences and publish in key journals

Associate Director, Global Health Economics and Outcomes Research

Content Writer

• Write documents supporting Phase 1 through IV clinical trials
• Collaborate closely with cross-functional teams
• Ensure that documents are of the highest quality and compliant with global regulatory requirements
• Contribute to updates to standard operating procedures
• Stay current with regulatory guidelines, industry trends, and best practices in medical writing

GMP Quality Assurance Specialist

Associate Director, Global Health Economics and Outcomes Research

Associate Director, Medical Writing