Mary Ann Slack serves as Director of CDER’s Office of Strategic Programs (OSP). OSP plays a lead role in many of the center’s strategic initiatives and modernization efforts, including development of benefit-risk and other decision support tools, data standardization, lean process management, program analysis, informatics, capacity planning, and major user fee negotiations. OSP leads implementation of CDER’s business informatics governance function in support of business modernization objectives.
Since joining CDER in 2003, Ms. Slack has led numerous large, complex initiatives with broad stakeholder impact. She established and leads CDER’s data standards program, co-chairs FDA’s Data Standards Advisory Board, and represents FDA’s needs on HL7’s Board of Directors. She successfully led the cross-organizational Pharmaceutical Program Alignment implementation working group , leads a cross-organizational expert team in defining FDA’s capability assessments of inspectorates and operational implementation of the FDA-EU mutual recognition agreement, and represents FDA as a topic expert on ICH’s MedDRA Management Committee and M2 multidisciplinary working group.
Ms. Slack has extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing solutions. She received her bachelor of science degree in computer science with a minor in mathematics from the University of Maryland.