At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose:

The Global Regulatory Affairs Product Owner role is responsible for establishing technical and operational excellence of the assigned product area within the Veeva Vault Regulatory Information (RIM) system or related technologies. The role will leverage a deep understanding of the sAFE© framework, system configuration, and functionality to drive the business valuation, prioritization, development, implementation and ongoing maintenance of the regulatory information management strategy, for assigned area of focus while contributing to the integrated end to end automation strategy. The Product Owner will proactively collaborate with both internal and external partners on these new capabilities and technologies to drive continuous product improvement throughout the system lifecycle.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

System Technology and Product Ownership

• Own and drive the application and integration of functionality within assigned product area to deliver business value in alignment with organization strategy and goals. Develop product roadmaps to deliver value across the technology platform, ensuring that objectives in your assigned area are met, with quality, on time, on budget and within scope.

• Anticipate and proactively address technical challenges while navigating resolution to ensure product quality; leveraging your deep understanding of product/platform configuration expertise.

• Oversee and manage the product lifecycle from requirements inception to delivery, including design, development, and testing to ensure the changes/enhancements meet user and business goals.

• Maximize product value - Create, prioritize and manage the product backlog, ensuring that business requirements are well-defined, and in alignment with overall strategy.

• Collaborate with GRA Process owners to provide through to identify, create and manage operational metrics and other reporting opportunities that will improve the overall quality and operational excellence of regulatory processes.

Communication

• Create and deliver communications (both written and verbal) specific to product release activities for all applicable audiences and in various settings.

• Actively engage with internal stakeholders (end users, GRA Process Owners, Master Data Stewards, Tech@Lilly and other Third-Party Organizations to gather product insights and requirements, ensure alignment of development to business requirements and progress on deliverables.

• Serve as the primary contact for all product related inquiries.

• Coach and train others as needed, to ensure the effective implementation and adoption of technology products.

Minimum Qualification Requirements:

• Bachelor’s degree

• Experience as a technology system product owner or minimum of 2 years with expertise in process, technology, and information flows

• Experience with the Agile framework, sAFE© and JIRA

• Demonstrated working knowledge and application of Computer System Validation requirements

• Working knowledge of Veeva Platform coupled with regulatory business process OR direct experience with the Veeva Vault Regulatory Information Management (RIM) application module.

Other Information/Additional Preferences:

• Ability to work effectively across global teams and manage multiple priorities.

• Strong analytical and problem-solving skills

• Strong communication and presentation skills, written and verbal.

• Previous experience collaborating with vendors for product development.

• Previous experience with business management processes, quality systems, process management.

• Previous experience leading implementation of emerging technology, automation, system changes or upgrades.

• Demonstrated influence with peers, leadership, and stakeholder groups.

• Proven ability to synthesize information from multiple sources, understand root causes, and make risk-based decisions.

• Excellent collaboration and teamwork skills

• Exceptional customer focus

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly