Document Control Assistant

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:

• Education: Bachelor’s degree in English, science, communications, liberal arts, health sciences, or related fields.

• Experience: Minimum of 2–3 years of document control, editing, or quality management experience in the pharmaceutical, biotech, or related regulated industry.

• 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)

• 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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment\_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.