Technical Writer

Technical Writer – Regulatory CMC DocumentationLocation: New Brunswick, NJ / Princeton Pike, NJSchedule: Monday – Friday, Normal Business HoursWork Model: 50% Onsite RequiredDuration: 12 Months (High possibility of extension based on performance and business needs)Position SummaryWe are seeking a Technical Writer with experience in Regulatory CMC documentation within the pharmaceutical or biotechnology industry. This role will support regulatory submission activities for a late-stage cell therapy program and will work closely with cross-functional teams including Regulatory Affairs, Process Development, Analytical Development, Quality, and Technical Operations.The ideal candidate will have hands-on experience supporting eCTD regulatory submissions, strong technical writing capabilities, and the ability to manage multiple timelines in a fast-paced environment.ResponsibilitiesAuthor, edit, and review Regulatory CMC documentation for regulatory submissionsSupport preparation of dossiers and submission-related documents aligned with regulatory strategyCoordinate with SMEs to gather source documentation and ensure timely content deliveryAssist with eCTD submission preparation and document management activitiesReview technical content for accuracy, consistency, formatting, and compliance readinessTrack submission timelines, document status, and project milestonesFacilitate comment resolution and support data verification activitiesCollaborate cross-functionally with Regulatory Affairs, Quality, Technical Operations, and Development teamsMaintain organized documentation and ensure adherence to submission deadlinesRequired QualificationsBachelor’s degree in Biology, Biotechnology, Life Sciences, or related disciplineMinimum 2+ years of Technical Writing experience focused on Regulatory CMC documentation within pharma or biotech industryFamiliarity with eCTD structure and regulatory submission processesStrong written and verbal communication skillsExcellent attention to detail, planning, organizational, and coordination skillsProficiency with Microsoft Office applications including Word, Excel, PowerPoint, and SharePointAbility to work independently and manage multiple priorities in a deadline-driven environmentPreferred QualificationsExperience supporting IND/BLA submissionsCell therapy or biologics experience preferredExperience working with cross-functional regulatory and scientific teamsFamiliarity with compliance-ready document formatting and publishing standards