Simon Cooper

Background

About Simon Cooper

Experienced in Quality Improvement and regulatory affairs, with significant experience with both national and international regulatory bodies. I have a deep interest in evidence-based quality improvement through data analytics and automation of quality improvement. I have the following skills- Clinical data management skills where I have developed analytics and indicators to measure healthcare performance - Business development, management, and strategic planning skills - I have project managed implementation of multiple software systems as well as acted as systems development lead - I have led audits and have managed a CAPA / LEAN improvement system including adverse event reporting/investigation, post market surveillance and cGMP manufacturing deployment - Outstanding written skills with experience developing collateral such as research papers, guides, cGMP compliant dossiers and technical master files - Extensive experience liaising with both government and non-government stakeholders from C-suite / Chief Health Officers to Clinicians - Technical and scientific product development skills including BioPen / BioInk development and development of a test for blood doping, which was implemented at the Olympics Specialities: Quality management, Data Management, Health data analytics, Clinical Indicator development, Stakeholder management, Leadership and governance, Regulatory affairs, Software systems implementation; Facility establishment and management, Strategic planning and development, Business development and modelling, Medical science liaison, Product development, and Research and development.