Technical Writer (New Brunswick)

**Please only local candidates to New Brunswick NJ83415TSR 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:Bachelors degree in Biology or related discipline with a minimum of 2 years experienceMinimum of 2 year of experience in Technical Writing specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industryFamiliarity with eCTD structure for regulatory submissionsProficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is requiredPay: $43-44/hour W2Location: New Brunswick NJResponsibilities:Will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy from early stage through registrational applicationThis role requires effective collaboration across technical functions to deliver on timelines for submissionsThe position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences 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 reportsPlan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assetsManage the logistical process and detailed timeline for regulatory submissionsPartner 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

Created: 2025-09-24