Make your mark for patients
We are seeking a highly skilled Study Document and Records Management Specialist who is innovative and agile to join our Early Development Pipeline & Processes Management, Non-Clinical Business Processes team, based in Braine, Belgium.
About the role
This position plays a critical role in managing study-related documents and ensuring that submission-related documents comply with regulatory submission specifications. The role will drive the quality, compliance, and effectiveness of non-clinical study documentation and processes.
The Study Document and Records Management Specialist provides business and technical expertise and drives for excellence within operations, processes, documentation, and compliance with R&D regulations within Patient Solutions, with global reach, challenge and influence.
Who you’ll work with
The role is global and cross-functional, involving collaboration with a variety of internal and external stakeholders, including Non-Clinical function, Non-Clinical Medical Writing, Regulatory Affairs, Quality Assurance, and Contract Research Organizations (CROs).
What you’ll do
1. Manage study documents and records lifecycle ensuring traceability and integrity, serve as Business Administrator.
2. Ensure document formatting aligns with UCB’s writing styles and regulatory submission standards. Collaborate with Regulatory and Submission-Publishing teams for submission-readiness checks and publishing outputs.
3. Ensure audit and inspection readiness of all documents managed in the Electronic Content Management, i.e. Veeva Vault, in line with the Quality Control Strategy.
4. Provide training, end user support and contribute to reviewing procedural documents and internal business documentation.
5. Deliver outstanding service, offer a client-centred service to in-scope users, focusing on e-content management systems and business procedures in a regulated framework.
6. Act as back up GLP Archivist (Good Laboratory Practice), archiving of in-scope records and materials in compliance with applicable regulatory requirements, critical activity list.
Interested? For this role we’re looking for the following education, experience and skills
7. Scientific background.
8. Industry experience in the pharmaceutical industry, knowledge of pharmaceutical development processes, conduct of non-clinical studies and scientific deliverables.
9. Proven experience in document and records management.
10. Proven experience under GxP (GLP, GCP) regulations.
11. Experience in database management, ECMS (Electronic Content Management Systems, e.g. Veeva Vault) and Quality Control management.
12. Proficient in Microsoft Office Suite.
13. Customer focused, service management oriented, problem-solving and solutions driven.
If you are interested to learn more about R&D within UCB, please find more information here .
RANDATUCB
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!