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Technical Writer/Regulatory Affairs (New Brunswick)
Technical Writer/Regulatory Affairs (New Brunswick)TSR Consulting • New Brunswick, NJ, US
Technical Writer / Regulatory Affairs (New Brunswick)

Technical Writer / Regulatory Affairs (New Brunswick)

TSR Consulting • New Brunswick, NJ, US
4 days ago
Job type
  • Part-time
Job description

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 :

  • Bachelors 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
  • 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
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    Technical Brunswick • New Brunswick, NJ, US

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