What are the responsibilities and job description for the Technical Writer position at TSR Consulting?
TSR Consulting is currently seeking a highly motivated Technical Writer / Document Specialist for a hybrid opportunity in New Brunswick, NJ
Role: Technical Writer / Document Specialist
Duration: 1 Year
Locations: New Brunswick, NJ
Anticipated Start Date: 06/01/2026
Job Type: Contract – hybrid
We are looking for a Technical Writer / Document Specialist with strong Regulatory CMC documentation experience in the biotech/pharma industry.
Key Responsibilities:
- Experience with Regulatory CMC Technical Writing
- Strong hands-on experience with Module 3 authoring/documentation
- Familiarity with eCTD structure and regulatory submissions
- BLA submission experience is highly preferred
- Experience in Cell Therapy is preferred; a Biologics background will also be considered
- Ability to manage submission timelines and coordinate with cross-functional teams
- Experience working with Process Development, Analytical Development, Quality, Regulatory Affairs, and Technical Operations teams
About TSR:
TSR Consulting (TSR, Inc.) is an established IT staffing and consulting firm operating since 1967, specializing in providing technical talent, project management, and specialized services across various industries, including energy, financial services, and life sciences. They offer both contingent staffing and permanent placement solutions.