Document and Records Management Expert (m/f/d)

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

Capacity: 5 days per week

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