United Kingdom
Leading the global Operations function supporting our Global Regulatory Affairs, Global Patient Safety and R&D Quality teams within Merck Healthcare. Driving value through synergy, simplicity and excellence by building and leading teams to deliver on our submission, technology, data and analytics visions.
Leading the Global Regulatory Operations function for Merck KGaA in its mission to deliver professional, high-quality strategic and tactical solutions to the GRA business and beyond. Overall accountable for driving global strategies for GRA systems, submissions delivery, document management, information management (incl. XEVMPD / IDMP) as well as potential future state RPA and AI activities.
As Head of Reg Ops for CSL Seqirus I led a team of operations professionals delivering document management, systems, publishing and information management support to the global business. My role later evolved to head up Regulatory Systems, Submissions and Data for the CSL enterprise due to the implementation of One R&D across the global business.
Leading the implementation of a full service Regulatory Operations function within the global Regulatory Affairs organisation. Business owner of Regulatory eDMS and publishing capability / strategy for all assets in the company portfolio.
Leads the global Regulatory Information Management team which is primarily responsible for the RIM strategy for Global Regulatory Affairs. Business System Owner of Regulatory Information Management system, accountable for implementation and management of Regulatory information standards. Has overall accountability for XEVMPD compliance and is Business Lead for IDMP compliance project. Currently Business Lead for new RIM system implementation project.
Providing local UK leadership expertise to a small team engaged in the provision of end user support for numerous specialist Regulatory systems. Started as London Site Lead and within a year assumed global responsibility for the whole team as interim Global Head.