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