Mark Mercer

Background

About Mark Mercer

Clinical Development and Manufacturing professional with a proven track record of success in the areas of Investigational Product development, Clinical, validation, and business analysis. Extensive background in the Biotech and Pharmaceutical industries from pre-clinical development through marketed products. Strengths include exceptional organizational skills and a keen approach to problem solving that results in optimal ROI for the organization. Adds value to any organization requiring an individual to wear many hats. Successfully interfaces with Clinical, Development, IT, Manufacturing, Quality, Regulatory Affairs, and Research. Specialties: Validation Management (/Processes/Software Systems), Systems and Software Engineering Electronic Trial Master File (eTMF) current / future state process mapping and implementation. Clinical Portal current / future state process mapping and implementation. Regulated Electronic Document Management systems current / future state process mapping and implementation. Taxonomy development for Bio-Pharma development and Regulatory Submission activities. Highly configurable systems acquisition and implementation. Systems integration. Work best in a small team and multi-cultural environment