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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $178,200

Position Brand Description: Regulatory Compliance & Post Market Reporting

This position is responsible for providing data analytics support across the different auditing, regulatory reporting and inspection support teams that resides in the Global Quality Compliance organization. 

Key Objectives/Deliverables:

In this analytics role, the individual works with the Process Owners across GQAAC (global quality auditing & compliance) and Regulatory Compliance & Post Market Reporting teams. Will function as the Business Quality Assurance representative on analytics projects to ensure compliance with Lilly standards.

This role will participate in the different phases of the lifecycle of reporting/analytics solution, starting with the dialogue with business users to identify unmet business needs, following with the design of a proper solution, the deployment of the same and finally ensuring that the business users effectively find their needs met. A fundamental aspect is to ensure the sustainability of the reporting/analytics solution establishing/promoting the necessary Governance. The support that they may provide to the different programs are as shown below.

Compliance & Auditing Support

Research, classify, trend, and analyze GxP compliance information received for the identification and communication of local and systemic issues or trends to global leadership.Serve as a global compliance data repository providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.Actively participate in AI/ML related projects and serve as SME on user stories, data architecture/staging, and ensuring continuous improvement.Provide information for use in various periodic reviews or metrics.Ability to translate and apply Health Authority (for example, FDA) standards into a Machine Learning/Surveillance Analytics dashboard for Inspection/Compliance Readiness.

Basic Requirements:

Bachelor’s degree or equivalent experience in a scientific field such as Pharmacy, Chemistry, Engineering, or other biological sciences.Minimum of 5 plus years relevant industry or Health Authority experience in areas which may include: Machine learning, Analytics, Technical services, Manufacturing, Quality, Surveillance.Data Science Expertise: Machine Learning Models, NLP analysisExpertise with R or Python, JMP at an advanced level with respect to statistical modeling, machine learning, and creation of dashboards.

Additional Preferences:

AWS or equivalent certifications (Machine Learning)

Other Information:

Ability to work independently and as part of a team with minimal supervision.Flexibility to effectively prioritize work activities to meet regulated timelines.Demonstrated strong oral and written communication and interpersonal interaction skills, with interaction at multiple levels of the companies.Ability to work across functional areas with people at all levels of the organization.Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.Organized with attention to detail.Multi-tasking and self-management to meet multiple overlapping timelinesLocations: Any Lilly US manufacturing site or corporate headquarters in Indianapolis.

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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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