Operations Specialist, Data Generation and Managed Access, Global Medical Affairs

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.

You will need to have:

• Bachelor's degree in a relevant discipline
• Experience with enterprise IT systems such as Clinical Trial Management System and study documentation review systems
• Project management skills including defining project scope, budget, timeline, resource management and use of associated tools.
• Ability to professionally interact with internal and external stakeholders
• Proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

We would prefer for you to have:

• 1 years+ Experience in Medical Affairs
• Experience with external contractor/vendor management

Date Posted

19-Aug-2025

Closing Date

18-Sep-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.