Study Document and Records Management Specialist

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

• Manage study documents and records lifecycle ensuring traceability and integrity, serve as Business Administrator.
• 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.
• 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.
• Provide training, end user support and contribute to reviewing procedural documents and internal business documentation.
• 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.
• 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

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!