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:

• 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
• 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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