Observational Project Management: Oversee the operational management of RIPH3-type observational studies, ensuring timelines are met and regulatory compliance is maintained.
Management of Exceptional/Early Access: Coordinate the implementation and monitoring of early access and compassionate use mechanisms (e.g., CPC / Compassionate Prescription Frameworks).
Off‑label (Outside Marketing Authorization) Management: Supervise the transition and follow-up of medicines used outside marketing authorization into the appropriate regulatory frameworks.
Cross‑functional Coordination: Serve as the interface between health authorities, investigator sites and internal departments (medical, regulatory, supply).
Operational Monitoring: Ensure the quality of collected data and adherence to specific processes.

Advanced scientific degree (Master's level, PharmD, PhD or Master’s in Clinical Development / Regulatory Affairs)
Proven initial experience managing non‑interventional (observational) projects
Ideally, experience with early access mechanisms and compassionate prescription frameworks
Good knowledge of RIPH regulations

Consultant – RWE Project Manager

Key skills