Marion Mays

Marion has a wealth of experience leveraging the competitive advantage of managing records and the TMF in an audit-ready manner, having steered the development and implementation of regulated, enterprise-wide programs across organizations. An industry leader in Information Management with over 25 years of experience in the Pharmaceutical industry. An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the advancement of clinical outcomes. Highly skilled in developing and implementing enterprise-wide programs and systems in regulated environments with proven record of success in technical problem solving. In-depth experience with quality and compliance processes in the pharmaceutical industry including supporting organizations through major regulatory inspections with FDA, MHRA, EMA, and PMDA. Experience in R&D, Clinical Research, Manufacturing, Quality Assurance, Records & Information Management, Quality Control, Operations, and Systems Implementation.

Recent Posts

Achieving and Maintaining Sponsor Oversight of Outsourced Studies

Regulators have made it abundantly clear, through recent guidance and inspection findings, that compliance ...

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