Make your mark for patients
We are looking for an Archivist, Document and Records Management employee to join us in our Patient Solutions organization based in Braine-l’Alleud, Belgium.
About the role:
The position is based in the UCB offices at the Braine-l’Alleud campus.
In this position, you will provide business and technical expertise and drive for excellence within operations, processes, documentation, and compliance with regulatory requirements within Patient Solutions, with global reach, challenge, and influence.
You have a deep understanding of the core business activity of Patient Solutions as well as operational skills to effectively engage with varied stakeholders and ensure the broad remit of the role.
Under the direction of the Leader of Non-Clinical Submission Excellence Team, within Patient Solutions Operations, you will be responsible for the operational management of regulated and non-regulated documents, procedures, and contributions to regulatory submissions. You will ensure organizational efficiency and compliance with national or international legislation.
You will support and actively contribute to Business Process Improvement (BPI) initiatives across Patient Solutions Operations to streamline, simplify, standardize processes to increase quality and enhance operational efficiency.
What you will do:
1. Manage day-to-day operations of regulated and non-regulated documents, scientific data records, procedures and contributions to regulatory submissions
2. Ensure appropriate archiving of in-scope records and materials in compliance with applicable regulatory requirements (inter alia)Ensure that access to the archive is controlledEnsure that the orderly storage and retrieval of records and materials is facilitated by a system of indexingEnsure that movement of records and materials in and out of the archives is properly controlled and documented
3. Ensure the transfer of in-scope records to an external archiving facility, as applicable
4. Develop, update documentation (SOPs, business, training)
5. Provide training and support to in scope users on document management systems and related procedures
6. Proceed to Quality Control and Reporting (metrics/KPI’s)
7. Support and actively contribute to the Business Process Improvement (BPI) initiatives in order to streamline, simplify, standardize e-content management and archiving processes and related procedures
8. Participate in the implementation of new and upgraded document management systems to ensure business requirements remain covered for the in-scope users’ community and compliance with regulatory requirements
9. Participate in testing of new/upgraded document management systems
For this position you’ll need the following education, experience and skills:
10. Experience of working in pharma industry, knowledge of pharmaceutical development processes and scientific deliverables
11. Experience of pharmaceutical submission-related activities and an awareness of the latest standards required for regulatory submissions including international guidance’s published by the regulatory agencies such as FDA, EMA
12. Proven experience in document management and archiving
13. Proven experience under GxP (GLP, GCP) regulations
14. Proven experience in ECMS (Electronic Content Management Systems)
Competencies:
15. You are analytical and process minded
16. You are sequential, methodical
17. You are quality oriented, with an eye for detail
18. You have excellent communication skills English - French
19. You have excellent planning and organizational skills
20. You have extensive computer skills
21. You are customer focused
22. You are service management oriented, problem-solving, solution 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!