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TSR Consulting Services, Inc.
Technical Writer

Technical Writer

On site

New brunswick, United states

$ 44 /hour

Junior

Freelance

17-11-2025

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Skills

Technical Writing

Job Specifications

83415

***Local candidates to New Brunswick NJ ONLY please

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a Technical Writer for a 12+ months contracting assignment.

Must have skills:

Bachelor’s degree in Biology or related discipline with a minimum of 2 years’ experience
Minimum of 2 year of experience in Technical Writing specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industry
Familiarity with eCTD structure for regulatory submissions
Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required

Pay: $43-44/hour W2

Location: New Brunswick NJ

Responsibilities:

Will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy from early stage through registrational application
This role requires effective collaboration across technical functions to deliver on timelines for submissions
The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences across CTDO
Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports
Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets
Manage the logistical process and detailed timeline for regulatory submissions
Partner with SMEs to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy

About the Company

TSR is a relationship-based, customer-focused IT and technical services staffing company. For over 50 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, Inc. have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients. We've been around for so long for a reason. We're nimble. And responsive. Our core missio... Know more