Location: Remote - Thousand Oaks, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $38/$42 per hour (based on experience)

Summary of the Role

Support the end-to-end lifecycle management of R&D controlled documents for a big biopharma leader, ensuring compliance with regulatory standards and internal quality procedures. Oversee document workflows and perform rigorous quality control (QC) reviews to maintain consistency and accuracy. Collaborate with cross-functional teams and facilitate document readiness for audits and inspections.

Key Responsibilities

• Coordinate and manage controlled 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 technical editing and proofreading support to ensure consistency with templates and formatting requirements
• Conduct thorough QC reviews for regulatory, procedural, and formatting compliance
• Maintain and update document templates to ensure consistent use across all documents
• Support audits and inspections by preparing documentation and ensuring inspection readiness
• Collaborate with stakeholders and cross-functional teams to resolve document-related issues

Required Experience & Skills

• Strong project management skills, including milestone tracking and workflow oversight
• High proficiency in technical editing and document formatting
• Familiarity with regulatory documentation in a GCP or similar environment
• Experience with document management systems
• Demonstrated inspection readiness

Top 3 Must Have Skills

1. Project management for documentation workflows

2. Technical editing and document formatting

3. Experience with regulatory documents in a GCP or similar environment

Day-to-Day Responsibilities

• Coordinate document workflows and ensure tasks are completed on schedule
• Track and follow up on documentation milestones with contributors
• Edit and proofread documents to conform with approved templates
• Conduct quality control checks for regulatory and formatting compliance
• Update and maintain document templates
• Prepare documentation for audits and support inspection readiness
• Work closely with cross-functional teams to manage document-related activities

Basic Qualifications

• Bachelor’s degree and 2 years of directly related experience
• Associate’s degree and 6 years of directly related experience
• High school diploma / GED and 8 years of directly related experience

This posting is for Contingent Worker, not an FTE