TSR Consulting is hiring: Technical Writer in New Brunswick

This range is provided by TSR Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$43.00/hr - $44.00/hr

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+ month contracting assignment.

Must have skills:

• Bachelor’s degree in Biology or a related discipline with a minimum of 2 years’ experience
• Minimum of 2 years 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, PowerPoint) is required

Pay: $43-44/hour W2

Location: New Brunswick, NJ

Responsibilities:

• Deliver CMC documentation (dossier and supporting documents) to support the regulatory strategy from early stage through registrational application
• Collaborate across technical functions to meet submission timelines
• Interface with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality, and Regulatory Sciences across CTDO
• Co‑author 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 with project timelines and CTD requirements and regulatory strategy

Seniority level: Associate

Employment type: Contract

Job function: Other

Industries: Pharmaceutical Manufacturing