Controlled Documentation Lead

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 suppor...