Study Document and Records Management Specialist
Are you passionate about ensuring compliance and operational excellence in document and records management? We’re looking for a Study Document and Records Management Specialist to join our client and play a critical role in managing regulated and non-regulated documents throughout their lifecycle.
What You’ll Do
* Oversee the lifecycle of study documents and records, ensuring traceability, integrity, and compliance with national and international regulations.
* Act as Business Administrator for electronic content management systems (e.g., Veeva Vault).
* Ensure document formatting aligns with regulatory submission standards and collaborate with Regulatory and Submission-Publishing teams for submission readiness.
* Maintain audit and inspection readiness for all managed documents in line with Quality Control strategies.
* Provide training and end-user support, and contribute to reviewing procedural and internal business documentation.
* Deliver exceptional client-focused service, supporting users with e-content management systems and business procedures in a regulated framework.
What We’re Looking For
* Excellent planning, organizational, and communication skills (English/French proficiency preferred).
* Strong analytical and problem-solving abilities.
* Process- and compliance-oriented mindset with attention to detail.
* Extensive computer skills and familiarity with electronic content management systems.
* Customer-focused, solution-driven approach.