Strategy Lead, Submission Automation

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Team Overview:

AbbVie Development Sciences (Dev Sci) is an integrated, cross-functional R&D organization that includes CMC (Process R&D, Drug Product Development and Analytical R&D), Biological Sciences (Preclinical Safety and Drug Metabolism, Pharmacokinetics & Bioanalysis) and Clinical Drug Supply Management functions responsible for the development of small molecule pharmaceuticals and therapeutic biologics from Discovery Candidate Selection through late stage clinical. The Data & Digital Strategy CORE team within Development Sciences defines and executes our data and digital strategy in collaboration with Dev Sci subject matter experts and Information Research (IR). The Data & Digital Strategy team partners cross-functionally to build and maintain a data and systems architecture that enables world-class knowledge management, data analytics and predictive modelling capabilities. We are looking for diverse candidates with a blend of product development, informatics and data systems experience who can help advance our data and digital capabilities.

Role Overview:

The Strategy Lead, Submission Automation is responsible for shaping and advancing the business strategy, roadmap, and cross-functional execution approach for report automation supporting dossier submissions (e.g. INDs, BLAs) across modalities. This role partners closely with dossier management, Development Sciences, Regulatory Affairs, and IT to understand current-state reporting needs, identify opportunities for automation, and define scalable business and systems strategies that improve the efficiency, quality, and consistency of submission-related reporting.

The incumbent serves as a strategic lead across business and technical stakeholders, translating reporting and submission needs into a forward-looking automation roadmap and enabling the development of sustainable capabilities that support evolving regulatory and organizational priorities. Over time this role will lead other cross-functional data, digital, and automation initiatives across Development Sciences.

Key Responsibilities