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Scientist/Senior Scientist, Nonclinical Safety Evaluation (NSE)Apply Now

Location: Waltham, Massachusetts
Employment Type: Contract

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Job Description

Contract Length:  6+ months, Hybrid schedule

Job Summary:  Ensure timely and high-quality deliverables meet the company’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.

Responsibilities:
 
  • Review and QC Nonclinical Safety Evaluation (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
  • Review and QC NSE information in candidate nomination documents and presentation slides
  • Process Work orders, Change orders and track invoices against installment payments in contracts

Requirements:
 
  • 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
  • Exceptional attention to detail
  • Strong oral and written communication skills
  • Ability to work successfully independently and collaboratively
  • Significant knowledge of GLP regulations for the conduct of NSE studies
  • Considerable experience reviewing:
    • GLP NSE study protocols, reports, amendments
    • NSE sections of regulatory documents
  • Familiarity with drug development process
  • Familiarity with NSE studies required for registration of biologics for cancer
  • Knowledge of regulatory submissions and NSE guidance for biologics for cancer

Contact

Jared Potter
Principal Recruiter

He's a natural people person.


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