Documentation Analyst

Location: New Brunswick, NJ • Duration: 12 months with possible extension • Pay rate: $36.80–$41.80/hr (W2) • 50% onsite required

About the role

This individual will deliver CMC documentation (dossier and supporting documents) to support the regulatory strategy from early stage through registrational application. The role requires effective collaboration across technical functions—Process Development, Analytical Development, Cell Therapy Technical Ops, Quality, and Regulatory Sciences—to meet submission timelines.

Responsibilities

• Manage the logistical process and detailed timeline for scientific and regulatory content creation for clinical and life-cycle CMC regulatory submissions and responses to health authority questions.
• Review and adjudicate comments in collaboration with technical subject-matter experts; facilitate resolution of grammatical or formatting issues.
• Facilitate and manage the data-verification process.
• Assist with dossier creation and ensure system compliance for regulatory submissions.
• Track upcoming submissions and monitor ongoing submission progress.
• Represent Technical Writing and Document Management in cross-functional CMC teams.
• Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
• Engage with external suppliers for CTD content and review as needed.
• Support and implement continuous process-improvement initiatives.
• Train others on procedures, system access, and best practices.
• Mentor employees on the document-management process.
• Work independently under supervision and collaborate across scientific, project-management, and document-management teams in cell therapy.

Requirements

• Bachelor’s degree in Biology or related discipline with a minimum of 3+ years of experience.
• Cell therapy CMC experience required; familiarity with regulatory requirements and guidance for CMC documentation preferred.
• Familiarity with eCTD structure for regulatory submissions required; BLA experience strongly preferred.
• Proficiency in Microsoft Office applications (Word, Excel, SharePoint, PowerPoint).
• Experience with computer-assisted document-preparation tools and compliance-ready publication standards preferred.
• End-to-end biotech/pharma product-development experience required.
• Ability to work in a fast-paced, changing team environment, prioritizing multiple tasks to meet filing deadlines.
• Occasional travel to other local NJ sites (2–3 times per year).

Skills

• Outstanding verbal and written communication.
• Strong attention to detail, planning, organizational, and negotiating skills.
• Demonstrated ability to deliver on time.
• Ownership of section formatting, language checks, and cross-references to other sections/tables.

Schedule

Monday–Friday, normal business hours.