Top 8 Cmc technical writer Jobs

Regulatory CMC Technical Writer
SOKOL GxP Services —New Brunswick, NJ
- $68,702 - $87,256 a year
- Contract
- Hybrid work
- Microsoft Excel
- Mid-level
- Bachelor's degree
- Paid holidays
- Health insurance
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Senior Medical Writer
St. Jude Children's Research Hospital —Memphis, TN
- $78,000 - $139,360 a year
- Full-time
- Master's degree
- Continuous improvement
- Doctor of Philosophy
- Paid time off
Director, Regulatory Affairs - Clinical
Loyal —Remote
- $155,000 - $205,000 a year
- Remote
- Bachelor's degree
- Team management
- Mentoring
- Paid holidays
- Health insurance
Director, Clinical and Technical Writing
Kiniksa Pharmaceuticals —Lexington, MA
- $223,000 - $236,000 a year
- Full-time
- 11+ years
- Bachelor's degree
- Continuous improvement
Quick Apply
Senior Scientist I / II - Biologics Analytical R&D
AbbVie —North Chicago, IL
- $109,500 - $208,500 a year
- Full-time
- Continuous improvement
- Doctor of Philosophy
- Organizational skills
- Paid holidays
- Health insurance
Manager Configuration and Data Management
Metropolitan Transportation Authority —Queens, NY
- $105,082 - $131,352 a year
- Microsoft Access
- 5 years
- Office
7d
Director, Due Diligence & Integration, TAT Clinical Programs
Ipsen Biopharmaceuticals Inc. —Cambridge, MA
- $177,000 - $259,600 a year
- Full-time
- Microsoft Word
- Background check
- English
- Commuter assistance
- Disability insurance
CMC Regulatory Strategist
Rho Inc —United States
- $190,000 - $210,000 a year
- Full-time
- Remote
- Analysis skills
- Doctor of Philosophy
- Conflict management
- Health savings account
- Paid holidays
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Regulatory CMC Technical Writer

SOKOL GxP Services -
New Brunswick, NJ

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Job Details

Contract
$68,702 - $87,256 a year

Benefits

Paid holidays
Health insurance
Referral program

Qualifications

FDA submissions
Biotechnology
Medical writing
Microsoft Excel
Content creation for technical audiences
Document control experience within pharmaceutical industry
Word embeddings
Project coordination
Collaboration with product development teams
Bachelor's degree
Pharmaceutical company experience
Compliance documentation
SharePoint
Chemistry, manufacturing & controls
Regulatory submission editing and review
Productivity software
Technical writing experience within technology
Cross-functional communication
Scientific reports

Full Job Description

SOKOL GxP Services seeking a Technical Writer and Document Specialist to support CMC documentation for a late-stage clinical cell therapy program. This role will sit within the Cell Therapy Development Project and Portfolio Management Office and will support regulatory submission activities, dossier preparation, and cross-functional document coordination.

The Technical Writer will author and co-author scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC submissions. This includes supporting Module 2.3 and Module 3 content, coordinating source documentation, managing submission timelines, reviewing and adjudicating comments, facilitating data verification, and helping ensure consistency and clarity across the dossier.

This position requires close collaboration with Process Development, Analytical Development, Cell Therapy Technical Operations, Quality, Regulatory Sciences, CMC matrix team leaders, project management, document management, and external suppliers as needed. The ideal candidate will be detail-oriented, organized, deadline-driven, and comfortable working in a fast-paced regulatory submission environment.

This is a 12-month hybrid contract position based in New Brunswick, NJ, with 50% onsite presence required and occasional travel to other local New Jersey sites for larger team meetings.

Requirements

Required Qualifications:

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.

Preferred Qualifications:

BLA regulatory submission experience strongly preferred.
Experience with computer-assisted document preparation tools preferred.
Proficiency in compliance-ready standards for final publication preferred.
Experience in biotech/pharma end-to-end product development preferred.
Experience training others on procedures, systems access, and document management best practices preferred.

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

Quick Apply

Refine Your Search

cmc technical writer jobs

Regulatory CMC Technical Writer

Senior Medical Writer

Director, Regulatory Affairs - Clinical

Director, Clinical and Technical Writing

Senior Scientist I / II - Biologics Analytical R&D

Manager Configuration and Data Management

Director, Due Diligence & Integration, TAT Clinical Programs

CMC Regulatory Strategist

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