Technical Writer (New Brunswick)
2 days ago
New Brunswick
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: • 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 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