THIS IS WHAT YOU WILL DO:

The Specialist provides support for the Data Generation portfolio and Managed Access Programmes in Global Medical Affairs. The incumbent will oversee processes, systems and activities related to Data Generation and Managed Access Operations, ensure data is centrally maintained, managed and available to various stakeholders as needed in a timely manner. They will assist with the adoption of innovative approaches to managing the portfolios and will collaborate with other business functions within the organization.

YOU WILL BE RESPONSIBLE FOR:

• Support day to day Data Generation and Managed Access operations in cooperation with associates across functions, including Legal, Compliance, Finance, Medical and Business Leads.
• Support the Data Generation Lead in the implementation of Global Medical Affairs (GMA) research review processes by facilitating receipt, processing and cross-functional review of internal and external study submissions.
• Responsible for documentation of review decisions and communication of outcomes to external investigators and internal study owners.
• Responsible for initiating start up activities of Externally Sponsored Research (ESR) studies including development of research agreement, vendor onboarding and purchase order requisition.
• Track the progress of ESR studies ensuring study updates are captured on an ongoing basis
• Lead study close out activities for ESR portfolio
• Organize the capture, archiving and reporting of all GMA data generation activities
• Manage all finance related aspects for GMA funded studies – invoicing, accruals, forecasting
• Responsible for coordinating the review of new patient managed access requests in line with our program policies.
• Handle the review and approval flow for ongoing product supply for existing patients in our managed access programs.
• Ensure compliance with the program requirements, maintaining appropriate records and tracking systems that are used to handle and monitor programs.
• Identify opportunities for continuous improvement to support audit and inspection readiness.