Regulatory CMC Technical Writer

About the role

SOKOL GxP Services seeks a Technical Writer and Document Specialist to support CMC documentation for a late-stage clinical cell therapy program. This role will be based in New Brunswick, NJ, with 50% onsite presence required and occasional travel for larger team meetings.

Responsibilities

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

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

Benefits

• Competitive hourly rate, $: 33.03 - 41.95 (W-2, no C2C option)
• Working hours: Monday to Friday, regular business hours
• Hybrid position: 50% onsite required
• Location: New Brunswick, NJ
• 12-month contract with possibility of extension
• Occasional travel to other local New Jersey sites for larger team meetings, approximately 2-3 times per year
• Health insurance, holiday pay, 401(k), referral bonus program