Onsite Regulatory Documentation Specialist (Contract)

System One, Inc.; South San Francisco (CA); On-site; USD 62,000 - 69,000; Full time

Job summary

System One is seeking a Technical Regulatory Documentation Specialist for an onsite contract role in South San Francisco, CA. The candidate will manage nonclinical regulatory documents, ensure accuracy, and support cross-functional teams in submissions.

The ideal candidate has 3+ years in scientific editing or document management, with strong MS Word proficiency and knowledge of regulatory submissions. Collaboration across Development Sciences and Regulatory Affairs is essential to meet

Qualifications

• 3+ years of scientific editing, writing, or document management experience.
• Knowledge of the drug development process and regulatory submissions is mandatory.
• Strong project management and organizational skills are mandatory.
• Experience leveraging AI-augmented tools and automation to streamline documentation workflows is preferred.
• Proficiency with MS Word.

Responsibilities

• Provide essential support for document lifecycle management, data entry, and workflow coordination for nonclinical documents supporting regulatory submissions.
• Ensure document accuracy and maintain organized digital libraries across functional groups.
• Collaborate with Submission Managers and project teams to ensure timely delivery of compliant documents meeting global standards.
• Publish finalized documents and reports within the document management system and perform QC to meet readiness standards.
• Format, edit, and track nonclinical documents (e.g., study reports, GLP statements, CRO reports) to ensure accuracy and consistency.
• Transfer and manage documents across digital libraries and metadata tagging across system records.

Skills

MS Word

Regulatory submissions knowledge

Project management

Attention to detail

Education

BA/BS in English, science, communications, liberal arts, or health-related field

Job description

System One is seeking a Technical Regulatory Documentation Specialist for an onsite contract role in South San Francisco, CA. The candidate will manage nonclinical regulatory documents, ensure accuracy, and support cross-functional teams in submissions.

The ideal candidate has 3+ years in scientific editing or document management, with strong MS Word proficiency and knowledge of regulatory submissions. Collaboration across Development Sciences and Regulatory Affairs is essential to meet