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

ZipRecruiter; New Brunswick; Hybrid; CAD 60,000 - 80,000; Full time

Job summary

A leading regulatory consulting firm is hiring a Technical Writer to support CMC regulatory submissions in New Brunswick, NJ. This hybrid role involves preparing detailed documentation for the Cell Therapy clinical portfolio and collaborating with cross-functional teams to ensure timely and accurate submissions. The ideal candidate has a degree in Biology and at least 2 years of experience in biotech or pharma, with strong scientific writing skills.

Benefits

Health benefits

Paid time off

401(k) program

Professional development support

Employee referral bonus program

Qualifications

• Minimum 2 years of experience in biotech or pharma, focusing on end-to-end product development.
• Strong knowledge of regulatory requirements for CMC documentation; cell therapy CMC experience required.
• Familiarity with eCTD structure and BLA submissions strongly preferred.

Responsibilities

• Author and co-author CMC content for CTD Quality sections.
• Plan and lead submission kick-offs, managing timelines and deliverables.
• Coordinate and track submissions and responses to Health Authority questions.

Skills

Scientific writing and editing skills

Planning and organizational skills

Communication skills

Attention to detail

Education

Bachelor’s degree in Biology or related discipline

Advanced degree

Tools

Microsoft Office Suite

Job description

Job DescriptionJob Description

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 .

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 .

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