Document Management Specialist Pharmaceutical Sector
We have a long- term contractor position for an experienced Document Management Specialist to support non-clinical (R&D) documentation activities within a regulated environment (GLP). The focus is on ensuring high-quality, submission-ready documents to support regulatory submissions, more precisely non-clinical study documents, not controlled documents. The role is embedded in a global team of document specialists collaborating closely with stakeholders from toxicology, pharmacology, bioanalysis, and regulatory affairs. The position is based in Wallon Brabant, Belgium. On site presence at least one day/week ideally 2. Position can be taken under employee or freelancer status.
Main Responsibilities
- 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.
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.
Languages
- Fluent English (written and spoken) is mandatory. French is a plus for the team
Interested please apply on line or call Karin for more information +32 50 498 17 67 47