TEMP - Toxicology Operations Specialist
About The Position
Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. This role performs day-to-day Toxicology and Safety Pharmacology study contracts-related activities, working with contract Research Organizations (CROs) to place studies supporting the discovery and development of the company’s development compounds. The specialist will also coordinate study archiving activities at various CROs, coordinate domestic and international Test Article (TA) shipments, and review and approve invoices for study and archiving activities.
Requirements
- BS degree
- Knowledge of processes in biotech, pharmaceutical industry and/or CRO
- Previous experience in placing and managing nonclinical studies at CROs
- Ability to work cross-functionally to ensure activities associated with Toxicology and Safety Pharmacology studies are successfully executed
- Proactive to identify and resolve operational problems efficiently
- Strong organization, computer, and communication skills
- Timeline oriented
Nice To Haves
- Experience in Toxicology is a plus
Responsibilities
- Perform day-to-day Toxicology and Safety Pharmacology study contracts-related activities
- Place Toxicology and Safety Pharmacology studies at CROs
- Assist with the management of Toxicology and Safety Pharmacology CROs
- Coordinate domestic and international TA shipments with Toxicology Program Leads, CMC, and the shipping department
- Review and approve invoices from CROs and other vendors as applicable
- Coordinate archival storage activities with various CROs
- Demonstrate proficiency with Neurocine Agiloft Portal (Contracts) and Coupa (Invoices) systems
- Perform periodic review of study tracking database (Smartsheet) for several CROs for accuracy and completeness
- Understand and keep up-to-date with current regulatory guidelines
- Other duties as assigned
Benefits
- 401k
- 401k_matching
- dental_insurance
- disability_insurance
- health_insurance
- life_insurance
- paid_holidays
- vision_insurance
- wellness_programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
