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.

Responsibilities

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