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

SOKOL GxP Services is hiring a Technical Writer – CMC Regulatory Submissions to support our client’s team in New Brunswick, NJ. This hybrid role will be part of the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO).

As a key contributor, you will be responsible for preparing CMC documentation, including dossiers and supporting materials, that shape the regulatory strategy for the Cell Therapy clinical portfolio — spanning from early-stage development through registrational filings. This role offers the opportunity to collaborate closely with subject matter experts across Process Development, Analytical Development, Technical Operations, Quality, and Regulatory Sciences, ensuring high-quality, timely submissions that advance transformative therapies to patients.

Key responsibilities include:

• Author and co-author CMC content for CTD Quality sections, ensuring alignment with regulatory strategy and scientific accuracy.
• Plan and lead submission kick-offs, managing detailed timelines, deliverables, and cross-functional collaboration.
• Coordinate and track submissions, including responses to Health Authority questions, data verification, and final dossier preparation.
• Partner with subject matter experts (SMEs) across CTDO to identify source documents, align on timelines, and deliver approved technical content.
• Ensure consistency, clarity, and accuracy of messaging across all CMC documentation.
• Review and reconcile comments with SMEs, manage revisions, and facilitate efficient comment resolution.
• Provide oversight for eCTD Modules 2.3 and 3, ensuring compliance with formatting, structure, and regulatory requirements.
• Collaborate with external partners as needed to review and finalize CTD content.
• Drive process improvements and contribute to best practices in regulatory writing and document management.
• Mentor and train team members on technical writing standards, systems, and submission processes.

Bachelor’s degree in Biology or a related discipline; advanced degree preferred.

Minimum 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; cell therapy CMC experience required.

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, with the ability to manage multiple priorities in a fast-paced environment.

Proven ability to work independently while thriving in cross-functional team settings.

Competitive hourly rate: $34 – $44/hr (W-2 only, no C2C)

Hybrid schedule (50% onsite Tu – Thu; full onsite during the first month)

12-month contract with possible extension

Health benefits, holiday pay, and 401(k) program

Paid time off (PTO) and professional development support

Employee referral bonus program

Opportunity to contribute to high-impact projects with a leading biopharma company