Onsite Contract Regulatory Document and Workflow Specialist

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

Job summary

System One in South San Francisco, CA seeks a Technical Regulatory Documentation Specialist to support nonclinical document lifecycle management for regulatory submissions. This contract onsite role requires editing, data entry, and coordinating with Submission Managers to ensure timely, compliant deliverables.

The ideal candidate has a science-related degree, 3+ years in editing or document management, and strong MS Word skills, with experience in drug development regulatory workflows and

Qualifications

• B.A./B.S. degree in English, science, communications, liberal arts, or a health-related field.
• Minimum of 3 years of scientific editing, writing, or document management experience.
• Knowledge of the drug development process and regulatory submissions.
• Strong project management and organizational skills.
• Ability to anticipate and solve issues impacting timelines.
• Experience leveraging AI-augmented tools and automation to streamline documentation workflows.
• 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, maintain organized digital libraries, and collaborate across functional groups.
• Work closely with Submission Managers and serve as a resource to project and submission teams to ensure timely delivery of high-quality, compliant documents meeting global regulatory standards.
• Build familiarity with internal processes, tools, and document management systems, seeking guidance from experienced submission managers as needed.
• Transfer and manage documents across digital libraries and folder structures.
• Accurately capture, identify, and apply metadata to files and system records.
• Publish finalized documents and reports within the document management system.
• Perform quality control and verification of documents to ensure readiness standards.
• Format, edit, and track nonclinical documents applying editorial standards and templates for accuracy and consistency.
• Retrieve missing information by searching archives and data sources.
• Initiate document records within tracking systems and match documents to project plans.
• Assess and develop timelines for document deliverables, supporting authors by tracking completion.
• Coordinate document hand-offs and review cycles among subject matter experts, authors, publishing teams, and stakeholders in Development Sciences, Regulatory Affairs, and others.
• Identify problems with documents or submissions and develop solutions with the team.
• Maintain internal team websites or portals and create/update content to keep information current.
• Serve as an editorial contact and communicate documentation processes to team members and stakeholders.

Education

B.A./B.S. degree in English, science, communications, liberal arts, or a health-related field

3+ years of scientific editing, writing, or document management experience

Strong written and verbal communication

Project management

Attention to detail

Experience with AI-augmented tools

Tools

MS Word

Job description

System One in South San Francisco, CA seeks a Technical Regulatory Documentation Specialist to support nonclinical document lifecycle management for regulatory submissions. This contract onsite role requires editing, data entry, and coordinating with Submission Managers to ensure timely, compliant deliverables.

The ideal candidate has a science-related degree, 3+ years in editing or document management, and strong MS Word skills, with experience in drug development regulatory workflows and