Strategy Lead, Submission Automation

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

Submission Automation Strategy

• Lead the strategy and roadmap for report automation supporting dossier submissions with a focus on business value scalability efficiency and compliance.
• Partner with the dossier management group and key stakeholders to understand current submission reporting processes pain points dependencies and future-state needs.
• Identify opportunities to standardize and modernize submission-related reporting through automation.

Business and Technical Alignment

• Work closely with IT and technical delivery teams to shape systems strategy and translate business needs into practical scalable automation solutions.
• Serve as a bridge between business process owners and technical teams to ensure alignment on priorities requirements dependencies and execution approach.
• Support development of business cases strategic recommendations and roadmap options for automation investments.

Cross-Functional Leadership

• Lead cross-functional alignment across Development Sciences Regulatory Affairs dossier management and other partner functions involved in submission content and reporting.
• Facilitate prioritization decision-making and issue resolution across multiple stakeholders and workstreams.
• Communicate roadmap priorities risks and recommendations clearly to leadership and cross-functional stakeholders.
• Influence without direct authority in a matrixed environment and build alignment around strategic direction and implementation priorities.

Qualifications :

Minimum Qualifications

• Bachelors Degree with 9 years experience; Masters 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.
• Knowledge of data reporting automation and governance concepts relevant to regulated business processes preferred.

Preferred Qualifications

• Experience working with submission processes dossier-related activities regulatory documentation or report automation strongly preferred.
• Experience partnering with technical teams to shape requirements and support delivery of business-focused solutions.

Additional Information:

• This is a hybrid (3x per week) role based in either Lake County IL or Worcester MA.
• This position reports directly to the Senior Director Development Sciences Data & Digital Strategy
• This position may acquire one direct report in the near term with the possibility of broader team building in the future.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time