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TSR Consulting is hiring: Technical Writer in New Brunswick
TSR Consulting is hiring: Technical Writer in New BrunswickMediabistro • New Brunswick, NJ, United States
TSR Consulting is hiring : Technical Writer in New Brunswick

TSR Consulting is hiring : Technical Writer in New Brunswick

Mediabistro • New Brunswick, NJ, United States
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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

83415

  • Please only local candidates to New Brunswick NJ
  • MUST have Cell Therapy or Biologics experience

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 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, 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
  • 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
  • Seniority level

    Associate

    Employment type

    Contract

    Job function

    Other

    Industries

    Pharmaceutical Manufacturing

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    Technical Writer • New Brunswick, NJ, United States