Job title: Document Control Assistant
Location: South San Francisco, CA
Shift: Regular hours
Pay Rate: $45/Hr
Position Overview:
Role Overview:
We are seeking a highly organized and detail-oriented Document Control Assistant to support the lifecycle management, editing, and coordination of nonclinical and regulatory documents. In this role, you will dedicate the majority of your time (60–70%) to editing, formatting, and performing quality control (QC) on essential pharmaceutical documents, with the remaining 30–40% focused on project coordination and workflow support. You will collaborate closely with Submission Managers and support various project and submission teams to ensure the timely delivery of high-quality, compliant documentation for global regulatory submissions.
Key Responsibilities:
Editing & Quality Control (60–70%)
- Review, edit, and finalize nonclinical and GxP documents (e.g., study reports, GLP statements, CRO reports, IND/BLA summaries, SOPs) for accuracy, consistency, and compliance with regulatory and internal standards.
- Apply established editorial guidelines, templates, and formatting to ensure internal consistency and readiness for submission.
- Perform comprehensive QC checks, identify and resolve errors or missing information, and retrieve or verify content from historical archives.
- Maintain document integrity, oversee version control, and ensure submission-ready quality.
Project Coordination & Workflow Management (30–40%)
- Support and coordinate document workflows, collaborating with authors, subject matter experts, publishing teams, and stakeholders in Development Sciences, Regulatory Affairs, and other functions.
- Initiate and maintain document records within tracking and document management systems (e.g., Veeva Vault).
- Accurately apply metadata, transfer and manage files across digital libraries and folder structures, and publish final documents in the management system.
- Monitor timelines, track deliverables, and facilitate review and approval cycles, proactively identifying and resolving issues that may impact deadlines.
- Support the development of deliverable timelines and regularly communicate document status to project teams.
Internal Communications & Content Management
- Serve as a resource for submission managers and project teams, communicating document processes and best practices.
- Manage and update internal team portals or websites, ensuring content is current and accurate.
Qualifications:
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Education:
Bachelor’s degree in English, science, communications, liberal arts, health sciences, or related fields.
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Experience:
Minimum of 2–3 years of document control, editing, or quality management experience in the pharmaceutical, biotech, or related regulated industry.
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Technical Skills (Required):
- Demonstrated hands-on experience with Veeva Vault or a comparable document management system
- Advanced proficiency in Microsoft Office, especially MS Word
- Familiarity with document compliance requirements for regulatory submissions (FDA, EMA, ICH, GxP)
- Understanding of drug development process, change control, and quality standards (e.g., 21 CFR 11/58/210/211, ISO 13485)
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Additional Skills:
- Excellent organizational, project coordination, and time management skills
- Strong written and verbal communication
- High attention to detail and accuracy; ability to work concurrently on multiple projects to tight deadlines
- Problem-solving and solutions-focused mindset; adaptable and collaborative
- Experience using or learning automation or AI tools for document tasks preferred
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