2025: Set up new medical information enquiry process for Russian affiliate (gbl biopharma)

Successfully established a compliant medical information enquiry process for the Russian affiliate, encompassing training, documentation and local regulatory alignment.

Successfully project-managed the establishment of a new, legally compliant medical information enquiry process for the Russian affiliate of a global biotechnology company. This critical initiative necessitated close collaboration with key Russian stakeholders, specifically the Head of Medical Information and the Lead Russian Medical Science Liaison. A core element involved meticulously mapping the revised enquiry workflow, mandating that all medical enquiries are initially directed to a newly created and locally managed Russian mailbox, handled exclusively by the Russian medical information team. Subsequently, enquiries could be escalated to the global third-party medical information contact center for resolution when required.

The project's execution demanded proactive and consistent stakeholder engagement across the Russian medical leadership, the global medical information department, and the external contact center. The project lifecycle encompassed several key phases: stakeholder mapping to identify all involved parties, detailed planning to outline project activities and timelines, precise implementation of the new process, rigorous testing to ensure system functionality and compliance, thorough training of relevant personnel, and a successful go-live. A dedicated two-week hypercare period was implemented to provide immediate post-launch support and address any arising issues. Throughout the project, a strong emphasis was placed on ensuring the Russian enquiry process aligned seamlessly with broader global medical information working practices and associated quality documentation, with careful integration of Russian data privacy regulations at every stage of the design.