Client: large biotech
Location: fully remote from anywhere in the US (standard hours 8-5)
Duration: 1 year + extensions
The Controlled Documentation Lead supports end-to-end lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes quality control, template adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system.
Day to Day Responsibilities:
• Coordinate and manage document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards.
• Track documentation milestones and follow up with contributors to ensure deadlines are met.
• Provide in-depth technical editing and proofreading support to maintain consistency with approved templates and formatting standards.
• Conduct rigorous QC checks to ensure all documents meet regulatory, procedural, and formatting requirements.
• Maintain and update controlled document templates and ensure consistent application across documents.
• Support audits and inspections through documentation readiness activities.
• Collaborate with cross-functional teams to execute document-related tasks and resolve workflow issues.
Basic Qualifications:
Bachelor’s degree and 2 years of directly related experience
OR
Associate’s degree and 6 years of directly related experience
OR
High school diploma / GED and 8 years of directly related experience
