Regulatory CMC Technical Writer

SOKOL GxP Services•New Brunswick, NJ

3d•$33 - $42•Hybrid

About The Position

SOKOL GxP Services is seeking a Technical Writer and Document Specialist to support CMC documentation for a late-stage clinical cell therapy program. This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document coordination. The Technical Writer will author and co-author scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC submissions. This includes supporting Module 2.3 and Module 3 content, coordinating source documentation, managing submission timelines, reviewing and adjudicating comments, facilitating data verification, and helping ensure consistency and clarity across the dossier. This position requires close collaboration with Process Development, Analytical Development, Cell Therapy Technical Operations, Quality, Regulatory Sciences, CMC matrix team leaders, project management, document management, and external suppliers as needed. The ideal candidate will be detail-oriented, organized, deadline-driven, and comfortable working in a fast-paced regulatory submission environment.

Requirements

Bachelor’s degree required; Biology or related discipline preferred.
Minimum 2 years of experience in technical writing for Regulatory CMC documentation within the pharmaceutical or biotechnology industry.
Familiarity with eCTD structure for regulatory submissions.
Experience supporting CMC regulatory documentation, dossier creation, and submission timelines.
Cell therapy CMC experience required.
Familiarity with CTD Quality sections, including Module 2.3 and Module 3.
Understanding of source documentation requirements for regulatory submissions and how source documents connect to the authoring process.
Strong verbal and written communication skills.
Strong attention to detail, planning, organizational, and negotiating skills.
Demonstrated ability to deliver high-quality documentation within filing deadlines.
Proficiency with Microsoft Office applications, including Word, Excel, SharePoint, and PowerPoint.
Ability to work independently under supervision and collaborate cross-functionally with scientific, regulatory, project management, and document management teams.
Ability to work in a fast-paced, changing team environment and prioritize multiple tasks.

Nice To Haves

BLA regulatory submission experience strongly preferred.
Experience with computer-assisted document preparation tools preferred.
Proficiency in compliance-ready standards for final publication preferred.
Experience in biotech/pharma end-to-end product development preferred.
Experience training others on procedures, systems access, and document management best practices preferred.

Responsibilities

Author and co-author scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC submissions.
Support Module 2.3 and Module 3 content.
Coordinate source documentation.
Manage submission timelines.
Review and adjudicate comments.
Facilitate data verification.
Ensure consistency and clarity across the dossier.
Collaborate with Process Development, Analytical Development, Cell Therapy Technical Operations, Quality, Regulatory Sciences, CMC matrix team leaders, project management, document management, and external suppliers.