Documentation Analyst

Job Title: Documentation Analyst
Location: New Brunswick, NJ 08903 (50% Onsite)
Duration: 12 Months+ Contract (High Potential for Extension)
 
Pay Rate: $41.80/hr. on W2
 
Travel: Occasional (2–3 times/year to local NJ sites)
 
Position Overview:
We are seeking a Documentation Analyst to join the Cell Therapy Development and Operations (CTDO) organization within the Pipeline Portfolio Management Office (PMO). This role supports the preparation and delivery of CMC documentation (including dossiers and supporting documents) required for regulatory submissions across the cell therapy clinical portfolio—from early development through BLA.
This individual will collaborate cross-functionally with internal experts in Process Development, Analytical Development, Technical Operations, Quality, and Regulatory Affairs. The role will focus on facilitating submission planning, document review workflows, comment resolution, and compliance with eCTD submission standards.
 
Primary Responsibilities:

• Manage timelines and logistics for scientific and regulatory content creation (CMC regulatory submissions, HA responses).
• Collaborate with subject matter experts (SMEs) to review content, adjudicate comments, and ensure clarity, formatting, and grammatical accuracy.
• Facilitate data verification and version control of CMC submission documents.
• Support dossier compilation, formatting, and system compliance for regulatory submissions.
• Track submission progress and upcoming milestones.
• Represent Tech Writing and Document Management in cross-functional CMC and regulatory team meetings.
• Coordinate with internal teams and external vendors/suppliers on content development and review.
• Provide training and mentorship on document processes, systems access, and compliance standards.
• Implement and support continuous improvement initiatives in document workflows.
• Own assigned document sections, ensuring consistency, accuracy, and alignment with regulatory strategy.

 
Required Qualifications:

• Bachelor’s degree in Biology, Life Sciences, or a related field.
• Minimum 3+ years of experience in biotech/pharmaceutical industry, specifically in CMC documentation.
• Experience in Cell Therapy CMC development is required.
• Knowledge of eCTD structure and regulatory expectations for CMC submissions is required; BLA submission experience is strongly preferred.
• Demonstrated ability to manage complex document workflows in a cross-functional environment.
• Excellent verbal and written communication skills with high attention to detail.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, SharePoint).
• Familiarity with document publishing and formatting tools (e.g., electronic submission tools).
• Ability to work independently under supervision and in a team setting.

 
Preferred Qualifications:

• Experience with regulatory systems and document submission platforms.
• Experience in end-to-end product development in biotech/pharma environments.
• Strong understanding of compliance-ready documentation standards for regulated submissions.
• Prior involvement in continuous improvement or process optimization in documentation workflows.

 
Key Competencies:

• Ownership and accountability for assigned sections
• Strong organizational and planning skills
• Self-starter with problem-solving mindset
• Collaborative team player with negotiation and influence skills
• Adaptable to fast-paced, high-pressure, and dynamic environments