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

Job Tags

Work at office, Local area,

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