Director - medical quality

1 month ago


Pennsylvania, United States Madrigalpharma Full time

Contribute to building a suite of Medical Affairs operational processes and systems, cross functional project management, training, metrics, analysis, insight generation, and continuous quality improvements supporting a rapidly growing peri-launch global Field Medical team
Ownership of Medical Affairs systems, such as CRM and reporting platforms, overseeing prioritization and implementation of new requirements and development of ongoing processes, balancing the technology supporting the business process and not being the business process
Orchestrate end-to-end implementation of Medical Affairs’ systems and projects such as technology vendor RFP/selection, configurations, pilots, user acceptance tests, data mapping/transfers, rollouts, training, hyper-care, metrics/analytics
Optimize Medical Affairs’ adoption, efficiency, and end-user success of systems while ensuring compliance with regulations and industry standards
Collaborate with cross-functional internal and external teams, including business analysts, system administrators, developers, vendors, quality assurance, regulatory affairs, commercial operations to define roles, align on strategy, operations, best practices, and metrics of the technology platforms
Be part of the Commercial IT LT team and coordinate solutions for a cohesive system architecture across the company
Lead operational aspects of data aggregations, analytics, obtaining and organizing data sets in collaboration with data analysts and AI teams to provide insights, KPI attainment reports, requirements for data warehouse, BI platforms and AI implementations
Support Med Affairs team with continuous real time and emerging analytics/metrics to quickly answer critical and ad hoc business questions related to department needs (e.g. medical products team, med info, health systems, fair market values, etc.)
Operationally support field team by coordinating system training materials and live training, troubleshooting, and collaborating on enhancements to adapt to business process changes
Research and evaluate new technology and data offerings that respond to medical affairs growth and new system needs (ie, grant requests systems, QR codes and website metrics/monitoring, medical/data visualizations and immersive experiences)
Understanding of evolving systems and processes that support and provide insights to Medical Affairs (e.g., Veeva CRM and MedComms, learning management systems, website development and monitoring, QR codes, medical review committee, medical information systems, etc
Broader understanding of security and privacy regulations, GDPR, internal/external audits CAPA management, 21 CRF Pt 11 compliance, management and government reporting needs
Wokring knowledge of late-stage clinical drug development and commercialization lifecycle core functions (ie, scientific engagement, publishing, field medical affairs, medical info management)
Experience with tools such as Power BI for data visualization and reporting
Experience in an emerging pharmaceutical company is a plus
Degree in Computer Science or Data Management background a plus; 10 yrs pharmaceutical experience, 3+ years working with and supporting Medical Affairs
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