Sr. Scientist

Job Title: Scientist/Sr. Scientist NSE
Hours Per Week: 20- Part Time
Location: Hybrid
Contract Length: 6 months

Position Summary:

Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet client's Discovery and Development goals; these deliverables include management/coordination of contracts, study-related documentation (protocols/reports), and regulatory submission documents, and program-related documents (e.g., candidate nomination). The role requires close collaboration with external contract research organizations (CROs) and client's Head ofto xicologist.

Responsibilities including but not limited to:

Review and QC NSE study protocols, study reports, and protocol/report amendments for external studies to ensure high quality deliverables from CROs

Review and QC NSE information in regulatory documents (e.g., prepare and/or review applicable NSE sections of IB updates, DSURs, Briefing books, INDs/BLAs)

Review and QC NSE information in candidate nomination documents and presentation slides (e.g., prepare and/or review applicable NSE sections of IB updates, DSURs, Briefing books, INDs/BLAs)

Process Work orders, Change orders and track invoices aProductst installment payments in contracts

Prepare and/or review/QC NSE meeting abstracts, presentation material, as needed

Support client's Oncology s Head of NSE/toxicologist, as needed

Education and Experience:

BS/MS with 6-10 years of experience in biotech/pharma or CRO in a nonclinical safety assessment organization or Quality Assurance group; PhD with 0-3+ years of applicable experience

• Must have familiarity with NSE / Toxicology Studies & related regulatory documents
• 6-10 years of experience
• Strong attention to detail & Written Communication skills