TEMP - Toxicology Operations Specialist

About the role

Perform day-to-day Toxicology and Safety Pharmacology study contracts-related activities. Work with contract Research Organizations (CROs) to place studies to support the discovery and development of the company’s development compounds. Coordinate study archiving activities at various CROs. Coordinate domestic and international Test Article (TA) shipments. Review and approve invoices for study and archiving activities.

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

Requirements

• BS degree and knowledge of processes in biotech, pharmaceutical industry and/or CRO, experience in Toxicology is plus
• 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

Pay

The pay you should reasonably expect to receive is $43.17 - $62.55 per hour. Decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.