Document and Records Management Expert (M/F/D)

Tasks:

• Perform quality control on non-clinical documents (protocols, amendments, reports, etc.).
• Ensure compliance and document readiness for regulatory submissions.
• Upload, index, and track documents in the Veeva Vault EDMS.
• Oversee the document lifecycle, ensuring adherence to quality standards and GLP requirements.
• Liaise with stakeholders (authors, QA, RA, etc.) for follow-up on corrections and approvals.
• Provide training and guidance to internal users on good documentation practices.
• Participate in process reviews and continuous improvement initiatives for documentation workflows.

Qualification:

Must-Haves

• Minimum 8 years of experience in the pharmaceutical industry.
• Solid background in regulated documentation management (GLP, GCP, etc.).
• Deep understanding of non-clinical documentation and its lifecycle.
• Hands-on experience with Electronic Document Management Systems (EDMS), preferably Veeva Vault.
• Familiarity with regulatory expectations for submission-ready documents.
• Strong digital literacy.
• Comfortable working in high-compliance, traceability-focused environments.

Nice-to-Haves

• Prior experience in non-clinical / preclinical environments.
• Exposure to QA or regulatory affairs.
• In-depth GLP knowledge.
• Scientific background (biology, chemistry, etc.).
• Understanding of French is a plus (for informal/team interactions).
• Familiarity with other document management tools.

Requirements:

Start: 05.05.2025

Duration: 8 months

End: 31.12.2025

Capacity: 5 days per week

Location: Braine and remote (up to 60% remote)