Technical Regulatory Documentation Specialist

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

Job Title: Technical Regulatory Documentation Specialist
Location: South San Francisco, CA
Type: Contract
Compensation: $45-50/hr
Work Model: Onsite

Responsibilities

• Provide essential support for document lifecycle management, data entry, and workflow coordination for nonclinical documents supporting various regulatory submission types.
• 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 (such as Pharmacology Subteams) to ensure the timely delivery of high-quality, compliant documents that meet 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 various 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 (QC) and verification of documents to ensure they meet readiness standards.
• Format, edit, and track nonclinical documents (e.g., nonclinical study reports, GLP statements, CRO reports, IND/BLA summaries), applying established editorial standards and templates to ensure accuracy, completeness, and internal consistency.
• Retrieve missing information by searching through historical archives and tracking down data.
• Initiate document records within the tracking and document management systems.
• Enter system data and accurately match documents to broader project plans.
• Assess and develop timelines for document deliverables, supporting authors by tracking the completion of documents.
• Manage collaborations by coordinating document hand-offs and review cycles between subject matter experts, authors, publishing teams, and stakeholders in Development Sciences, Regulatory Affairs, and other functions.
• Identify problems with documents or submissions and collaborate with the team to develop effective solutions.
• Manage and maintain internal team websites or portals.
• Create new content and perform routine updates to ensure information remains current.
• Serve as an editorial contact and communicate documentation processes to team members and stakeholders.

Requirements

• 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 is mandatory.
• Strong project management and organizational skills are mandatory.
• Ability to anticipate and solve issues impacting timelines.
• Ability to work concurrently on multiple projects, meet aggressive deadlines, and contribute effectively in a fast-paced, highly collaborative team environment.
• Strong written and verbal communication, solutions-focused mindset.
• High attention to detail to prevent inaccurate or substandard documents that could lead to submission corrections or delays.
• Experience leveraging AI-augmented tools and automation to streamline documentation workflows and enhance overall efficiency is preferred.
• Proficiency with MS Word.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.