Overview As Central Operations Principal within Patient Safety Operations, you steer end-to-end safety regulatory data delivery and drive process innovation for DSURs and PBRERs across Roche products and partnerships. You will lead cross-functional governance, optimize workflows, and ensure inspection readiness, contributing to safer medicines and global health impact. This role combines strategic oversight with hands-on operational delivery in a multinational setting. Verantwortungsbereiche Oversee end-to-end regulatory reporting delivery (scheduling, scope, data reconciliation, report generation, validation) and support cross-functional reviews Lead cross-functional process improvements to simplify workflows, automate steps, and reduce lead time and cost without compromising quality Establish and monitor process governance and KPIs; oversee service provider performance Serve as primary POC for regulatory inspections and audits; translate PV legislation into operational changes Collaborate with Clinical Operations, Biometrics/Data Sciences, Regulatory, Medical Affairs, Clinical Science, and Quality; foster coaching and cross-functional collaboration across the Affiliate network Zentrale Anforderungen Substantial experience in pharmacovigilance, pharma development, or healthcare Experience with business process management and global PV regulatory obligations Deep knowledge of DSURs/PBRERs, clinical trial design/conduct/reporting, clinical databases/management systems, and SDLC/systems validation Direct experience with regulatory inspections/audits and continuous process improvement Strong leadership, matrix management, and negotiation skills; experience managing Service Providers; international exposure across cultures/time zones Forward-looking and action-oriented mindset Strong collaboration and influencing abilities Negotiation and conflict-resolution skills DSURs and PBRERs expertise Clinical trial data management Regulatory reporting systems and databases
Central Operations Principal- Bussines Process Owner Arbeitgeber: Roche
Roche ist ein hervorragender Arbeitgeber, der eine inklusive und respektvolle Arbeitskultur fördert, in der jeder Mitarbeiter geschätzt wird. Als Biostatistiker (m/w/d) in der Forschung und Entwicklung hast du die Möglichkeit, in einem interdisziplinären Team an innovativen Lösungen zu arbeiten und deine Fähigkeiten kontinuierlich weiterzuentwickeln. Zudem bietet Roche zahlreiche Möglichkeiten zur beruflichen Entfaltung und unterstützt aktiv die persönliche Entwicklung seiner Mitarbeiter.
