Associate Scientist, Toxicology II

Role Summary

The Associate Scientist, Toxicology Study Coordinator supports the planning, conduct and reporting of non-GLP and GLP toxicology studies, acting to support the Study Director and regulatory infrastructure within the Preclinical Safety group.

Responsibilities

• Draft study plans, amendments, and report components
• Assist in the technical conduct of nonclinical studies including protocol set-up in electronic data capture system and scheduling of study events
• Perform data review periodically through study conduct and at study completion
• Facilitate communications among study personnel
• Coordinate the archival of study data and specimens
• Support GLP infrastructure through quality control responsibilities and active participation in process improvement activities
• Responsible for key tasks in the set-up and conduct of nonclinical studies
• Support the Study Director, acting as a designee for some tasks
• Study support may include data review, preparing report data tables, drafting report sections, coordinating study data archiving, and other tasks as needed
• Compile input from subject matter experts and incorporate into study plans
• Facilitate study scheduling and resource allocation
• Assist in driving assigned deliverables to timely completion
• Maintain training to meet compliance standards

Qualifications

• Basic:
• Bachelor’s Degree, or equivalent education, with typically 3+ years’ experience or Master’s Degree or equivalent education
• Degree in scientific field preferred
• Aptitude for managing multiple projects in a regulated environment
• Excellent oral and written communication skills
• Proven flexibility to deal with changing timelines, shifting work priorities, and evolving regulatory/industry requirements
• Computer skills appropriate for job task
• Preferred Qualifications:
• Expertise in Good Laboratory Practices
• Previous experience in the conduct and/or reporting of nonclinical studies