Nonclinical Data Associate (SEND)

Role Summary

Nonclinical Data Associate (SEND) within AbbVie's Toxicology & Pharmacology function, supporting 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

Qualifications

• Bachelors degree or equivalent experience required.
• Proficient with computer systems and software.

Preferred Qualifications

• BS in a scientific field preferred.
• 1-2 years of experience supporting nonclinical research and development in the pharmaceutical industry preferred.
• Understanding of toxicology or related nonclinical study conduct and design. GLP (or related regulatory environment) experience preferred.
• Experience with SEND and SDTM data sets