Nonclinical Data Associate (SEND)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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.

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.