Associate Director, Strategy Lead for Submission Automation
$141,500–$268,500 year
HybridNorth Chicago, Illinois, United States
Job Summary
Lead the strategy and roadmap for report automation supporting dossier submissions across INDs and BLAs, partnering with dossier management, Development Sciences, Regulatory Affairs, and IT to identify opportunities for standardizing and modernizing submission-related reporting. Translate business needs into scalable automation solutions by serving as a bridge between process owners and technical teams, shaping systems strategy and supporting development of business cases for automation investments. Facilitate prioritization, decision-making, and issue resolution across multiple stakeholders in a matrixed environment, communicating roadmap priorities and risks clearly to leadership. Influence cross-functional alignment to enable sustainable capabilities that improve the efficiency, quality, and consistency of submission reporting while advancing data and digital strategy within the integrated R&D organization.
Required Qualifications
- Bachelor's Degree with 9 years' experience
- Master's Degree with 8 years' experience
- PhD with 4 years' experience
- Significant experience in strategy, business process enablement, program leadership, or digital/data initiatives in a regulated environment
- Demonstrated ability to build roadmaps and lead cross-functional initiatives involving business and technology stakeholders
- Proven ability to work effectively across matrixed organizations and influence stakeholders at multiple levels
- Strong communication, facilitation, and stakeholder management skills
Desired Qualifications
- Knowledge of data, reporting, automation, and governance concepts relevant to regulated business processes
- Experience working with submission processes, dossier-related activities, regulatory documentation, or report automation
- Experience partnering with technical teams to shape requirements and support delivery of business-focused solutions
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