Job Description

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

Responsibilities:

Technical preparation of datasetsFollow established procedures to prepare datasets for nonclinical studies in accordance with the FDA Standard for Exchange of Nonclinical Data (SEND) requirements and internal standards.

Demonstrate a thorough understanding of the principles presented in regulatory guidance documents, as applicable to SEND dataset submission.

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 datasetsAssure correct dataset standardization and resolve nonconformances, using knowledge of nonclinical studies and SEND standards.

Collaborate cross-functionally to confirm information and resolve issues.

Communicate findings to internal/external partners and management, as appropriate.

Regulatory IntelligenceMaintain awareness of regulatory requirements pertaining to the submission of nonclinical data to regulatory authorities.

Implement process changes to comply with evolving requirements.