Location: Remote – U.S. (any time zone, standard business hours)
Employment Type: Contingent Worker (Contract, W2)
Compensation: $38–$43 per hour (based on experience)
Summary of the Role
Join a large biotech pharmaceutical leader as a Document Management Specialist (Controlled Documentation Lead). You’ll manage the end-to-end lifecycle of R&D controlled documents in an electronic DMS, ensuring compliance with regulatory standards and internal quality procedures. The role emphasizes workflow coordination, rigorous QC, template adherence, and on-time delivery.
Key Responsibilities
Coordinate and track controlled document workflows (e.g., SOPs, templates) to meet timelines and compliance standards
Perform technical editing/proofreading; enforce formatting and template consistency
Conduct QC checks to ensure regulatory, procedural, and formatting requirements are met
Maintain and update controlled document templates; drive consistent application
Support audits/inspections via documentation readiness activities
Partner cross-functionally to resolve workflow issues and keep milestones on track
Required Experience & Skills
Bachelor’s degree and 2+ years hands-on document management experience
Proficiency with Veeva/Viva or comparable document management platforms
Strong project management skills (milestone tracking, workflow oversight)
High proficiency in technical editing and document formatting
Familiarity with GCP or similar regulated documentation and inspection readiness
Excellent communication, organization, and attention to detail
Top 3 Must Have Skills
Workflow oversight & milestone tracking (project management)
Technical editing and formatting mastery
eDMS experience (Veeva/Viva or similar) with inspection readiness
"This posting is for Contingent Worker, not an FTE"