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.