Document and Records Management Expert

Own the integrity of every study: Become the Document & Records Management Expert driving compliance in a leading Belgian pharma team.

R&D Partners is seeking a Document and Records Management Expert to join a leading pharmaceutical company in Belgium. This role is critical in ensuring the proper classification, management, compliance, and availability of study documents for GLP-regulated research studies and hybrid cases. The position operates in a highly regulated environment, requiring attention to detail and the ability to navigate complex documentation processes.

Please note that to be considered for this role you must have the right to work in this location.

Please Note:

• Preference for candidates based in Belgium, with flexibility for exceptional candidates elsewhere.

Responsibilities:

• Manage and classify study documents within the electronic system (Veeva Vault).
• Ensure documentation is complete, compliant, accurate, and inspection-ready.
• Set up, track, and finalize electronic signature workflows.
• Maintain trackers for versions, amendments, and missing documentation.
• Act as a key contact for internal stakeholders needing guidance on documentation.
• Collaborate with CROs for document exchanges, clarifications, and follow-ups.
• Provide customer support to stakeholders struggling with documentation or processes.
• Utilize various documentation tools, including:
• Veeva Vault
• Starting Point Word add-in
• DocX Tools PDF add-in
• Outlook, Adobe, Word, etc.
• Contribute to continuous improvement in documentation processes.

Key Skills and Requirements:

Must-Haves:

Technical Skills:

• Experience in a scientific and/or regulated environment (GLP, GCP, GMP).
• Strong understanding of electronic document management principles (ECM).
• Experience with document management systems (Veeva or equivalent).
• General IT literacy (Office, PDF handling, workflows, metadata).
• High attention to detail, logic, and understanding of data integrity.
• Ability to analyze requests, even when stakeholders are unclear about their needs.
• Proficiency in English (speaking and writing).

Soft Skills:

• Highly organized, structured, and precise.
• Strong customer service approach with a pedagogical mindset.
• Clear communication skills with scientific stakeholders.
• Comfortable asking questions and acknowledging knowledge gaps.
• Willingness to learn and adapt.
• Flexibility to navigate different regulatory environments (GCP, GLP, Research).

Nice-to-Haves:

• Ability to train others on processes and documentation tools.
• Experience working with external partners (CROs).
• CTA or clinical documentation background with adaptability to GLP.
• French language skills (preferred but not essential).
• Direct Veeva Vault experience (an asset but not mandatory).

Ideal Candidate Profile:

• Background in life sciences (biology, chemistry, pharma) or solid experience in a regulated environment.
• Strong experience with electronic documentation systems.
• Comfortable interacting with internal and external global stakeholders.
• Curious, humble, transparent, and eager to learn.
• Able to eventually support training or coaching in documentation practices.
• Suitable profiles may include CTA, Documentation Specialist, Study Coordinator, or GLP/GCP documentation roles.

Additional Information:

Remote Work/Location:

• Preference for candidates based in Belgium (team currently located there).
• Flexibility possible for exceptional candidates based elsewhere, subject to management alignment.
• Expected onsite presence: 40%.

For more information, please contact Mandi Cakwe.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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