Technical Writer - CMC Regulatory Submissions (Hybrid, New Brunswick)

SOKOL GxP Services is seeking a Technical Writer – CMC Regulatory Submissions to support its team in New Brunswick, NJ. This hybrid role will focus on preparing regulatory documentation, including dossiers and supporting materials, for Cell Therapy clinical portfolio submissions. Collaboration with subject matter experts and strong organizational skills are essential.

Requirements

• Bachelor’s degree in Biology or a related discipline.
• 2+ years of experience in biotech or pharma, with a focus on end-to-end product development.
• Strong knowledge of regulatory requirements and guidance for CMC documentation.
• Familiarity with eCTD structure and BLA submissions strongly preferred.
• Exceptional scientific writing and editing skills with strong attention to detail.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint); experience with document preparation tools and compliance-ready standards.
• Excellent planning, organizational, and communication skills.
• Proven ability to work independently while thriving in cross-functional team settings.

Benefits

• Competitive hourly rate
• Health benefits
• Holiday pay
• 401(k) program
• Paid time off
• Professional development support
• Employee referral bonus program
• Opportunity to contribute to high-impact projects