Teams at WEP Clinical

Leads regional and global Post Approval Named Patient Programs and related clinical research projects, managing timelines, budgets, teams, client relationships, risks, training, quality, documentation, and regulatory compliance. Oversees eTMF and CTMS activities, site operations, payments, SOP adherence, change orders, and project delivery. Requires French fluency, clinical research or PA-NPP experience, knowledge of ICH GCP and clinical development, strong organizational and communication skills, and proficiency with Microsoft Office and clinical systems.

Lead global regulatory strategy and operational oversight for Expanded Access, Open Label Extension, and Post-Approval Named Patient Programs. Provide regulatory guidance across US, EU, UK, and other regions; maintain US licenses; engage regulatory authorities; support internal projects and client proposals; and manage, train, and develop Regulatory Affairs staff.