SRG are working with a global pharmaceutical company who are looking 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.
The role is embedded in a global team of document specialists based in Braine-l’Alleud, Belgium, collaborating closely with stakeholders from toxicology, pharmacology, bioanalysis, and regulatory affairs.
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. Frencj is a plus for the team
Soft Skills
- Highly reliable, structured, and detail-oriented.
- Strong quality and service mindset.
- Proven ability to collaborate in multicultural, cross-functional teams.
- Comfortable adapting to changing priorities.
Remote Work & Onsite Presence
- Remote work up to 60% (2–3 days/week).
- Onsite presence required 1 day/week in Braine-l’Alleud, ideally on Tuesdays (team day).
- Flexibility required based on operational needs.