Archivist, Document and Records Management

il y a 2 jours

Brainel'Alleud, Wallonie, Belgique UCB Temps plein

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:

  • Manage day-to-day operations of regulated and non-regulated documents, scientific data records, procedures and contributions to regulatory submissions
  • Ensure appropriate archiving of in-scope records and materials in compliance with applicable regulatory requirements (inter alia)
    • Ensure that access to the archive is controlled
    • Ensure that the orderly storage and retrieval of records and materials is facilitated by a system of indexing
    • Ensure that movement of records and materials in and out of the archives is properly controlled and documented
  • Ensure the transfer of in-scope records to an external archiving facility, as applicable
  • Develop, update documentation (SOPs, business, training)
  • Provide training and support to in scope users on document management systems and related procedures
  • Proceed to Quality Control and Reporting (metrics/KPI's)
  • 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
  • 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
  • Participate in testing of new/upgraded document management systems

For this position you'll need the following education, experience and skills:

  • Experience of working in pharma industry, knowledge of pharmaceutical development processes and scientific deliverables
  • 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
  • Proven experience in document management and archiving
  • Proven experience under GxP (GLP, GCP) regulations
  • Proven experience in ECMS (Electronic Content Management Systems)

Competencies:

  • You are analytical and process minded
  • You are sequential, methodical
  • You are quality oriented, with an eye for detail
  • You have excellent communication skills English - French
  • You have excellent planning and organizational skills
  • You have extensive computer skills
  • You are customer focused
  • 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 R&D at UCB.

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

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 equitable 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 and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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

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