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.

Requirements

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 .

Benefits

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