Job Description
Job Description
83415
***Local candidates to New Brunswick NJ ONLY please
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 across CTDO
- 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,