Study Document and Records Management Specialist (UCB - Braine L'alleud)

Offre d'emploi mise en ligne le 31/05/2025

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

  • Scientific background.
  • Industry experience in the pharmaceutical industry, knowledge of pharmaceutical development processes, conduct of non-clinical studies and scientific deliverables.
  • Proven experience in document and records management.
  • Proven experience under GxP (GLP, GCP) regulations.
  • Experience in database management, ECMS (Electronic Content Management Systems, e.g. Veeva Vault) and Quality Control management.
  • Proficient in Microsoft Office Suite.
  • Customer focused, service management oriented, problem-solving and solutions driven.

 

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!

About us 
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us? 
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Link: https://careers.ucb.com/global/en/job/90472/Study-Document-and-Records-Management-Specialist