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Jason Moore is currently a Solutions Architect at Orphan Drug Solutions. Jason has over fifteen years of experience in the pharmaceutical and biotechnology industries, with a focus on Regulatory Affairs, Clinical Affairs, and Quality Management.

Jason began their career in the pharmaceutical industry in January 2007 as Vice President of Clinical, Quality, and Regulatory Affairs at PLx Pharma LLC. In this role, Jason was responsible for leading all regulatory affairs functions, including both strategic and operational facets of RA. Jason provided comprehensive regulatory analyses of strategic development options and Agency positions, led all company-FDA meetings/negotiations, and managed all interactions with the Agency.

During their time at PLx Pharma LLC, Jason was also responsible for all regulated product submissions for 5 active INDs and 1 (approved) NDA. Jason led multidisciplinary teams to generate, review, and publish submissions. Jason has direct ā€œin-the-trenchesā€ experience with multiple eCTD platforms and dozens of electronic submissions, including the lead product eCTD NDA, which was approved in first review cycle.

In addition to their Regulatory Affairs experience, Jason also has extensive experience in Clinical Affairs. Jason led all clinical trial operations, from contract negotiation and protocol development to final study report, including work with CROs, domestic and international clinical sites, investigators and opinion leaders, and the integrated study team. Jason has a high success rate in achieving timeline/budget/quality expectations for complex trials of all

Jason Moore has a M.B.A. in Business Administration from the University of Houston, C.T. Bauer College of Business, a M.S. in Science & Technology Journalism (Medical Writing) from Texas A&M University, and a B.A. in Psychology from Texas A&M University. Jason also has certification from the Regulatory Affairs Professional Society in Regulatory Affairs Certification (RAC) - Global and Regulatory Affairs Certification (RAC) - US.

Jason Moore works with Milt Spanton - Co-Founder, Thomas Lembck - Co-Founder, and Nicole Pagoulatos - Business Analyst. Jason Moore reports to Akesh Gupta, Founder.