Central Operations Principal- Bussines Process Owner

Roche is a global healthcare company dedicated to advancing science and ensuring access to healthcare. The Central Operations Principal, acting as a Business Process Owner (BPO), will drive operational strategy, innovation, and execution of safety regulatory data delivery. This role is crucial for sourcing, preparing, and summarizing clinical trial information to produce mandatory aggregate safety reports across all Roche products and partnerships worldwide. The main day-to-day responsibilities include overseeing end-to-end regulatory reporting delivery, ensuring high quality and operational efficiency. This involves scheduling, data reconciliation, report generation, and validation. The role also requires leading cross-functional process improvement activities, simplifying workflows, automating processes, and driving cost reductions. Additionally, the BPO will establish robust process governance, monitor key metrics, and maintain oversight of service provider delivery. They will also serve as the primary point of contact for regulatory authority inspections and internal/partner audits, ensuring compliance and smooth operational changes. To excel in this role, candidates must have a degree in life sciences, with a postgraduate qualification such as a PhD, PharmD, MSc, or MD, or a formal PV qualification being strongly preferred. Substantial experience in pharmacovigilance, pharma development, or healthcare is required, ideally with experience in business process management and global PV regulatory obligations. A deep understanding of DSURs/PBRERs, clinical trial design, clinical databases, statistical trial analysis, and software development lifecycle is essential. Direct experience in regulatory authority inspections and a strong track record in continuous process improvement are also necessary. Nice-to-have skills include a forward-looking, action-oriented, and agile approach. Strong matrix management, systems thinking, negotiation, and conflict-resolution skills are beneficial. Extensive experience working with and managing service providers, and working in an international environment across cultures and timezones is also valuable. The role is based in Welwyn, offering a dynamic and inclusive work environment. What the role asks for: - Degree in life sciences (Postgraduate qualification such as PhD, PharmD, MSc, or MD, or formal PV qualification is strongly preferred). - Substantial experience in pharmacovigilance, pharma development, or healthcare. - Deep understanding of DSURs/PBRERs, clinical trial design/conduct/reporting, clinical databases/management systems, statistical trial analysis and reporting, and software development lifecycle (SDLC) / systems validation. - Direct experience representing processes in regulatory authority inspections/audits. - Strong track record in continuous process improvement.