Jobs at Abbvie – Nonclinical Data Associate

Job Description:

Within AbbVie’s Toxicology & Pharmacology function, the Nonclinical Data Associate will support regulatory submissions by reviewing and preparing Nonclinical Dataset Packages in accordance with FDA requirements.

Job Responsibilities:

• Integrate knowledge of nonclinical study conduct to assure correct dataset output
• Develop an understanding of Regulatory guidance documents used in dataset preparation
• Follow established procedures to prepare datasets for nonclinical studies in accordance with the FDA Standard for Exchange of Nonclinical Data (SEND) requirements and internal standards
• Use knowledge of regulatory requirements and toxicology study conduct to resolve and/or provide rationale for validation errors and warnings
• Capably use software and other tools to create compliant datasets and metadata (define.xml) files
• Communicate findings to team members and management
• Prepare Nonclinical Study Data Reviewer’s Guide (nSDRG) documents
• Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages

Job Requirements:

Qualification & Experience:

• Understanding of toxicology or related nonclinical study conduct and design. GLP (or related regulatory environment) experience preferred.
• BS in a scientific field preferred.
• Proficient with computer systems and software.
• Bachelors degree or equivalent experience required.
• 1-2 years of experience supporting nonclinical research and development in the pharmaceutical industry preferred.

Job Details:

Company: Abbvie

Vacancy Type:  Full Time

Job Location: Milwaukee, WI, US

Application Deadline: N/A

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