Associate – Data Analytics, Medical Quality Organization in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Associate – Data Analytics, Medical Quality Organization in Indianapolis, Apply Lilly careers in Indianapolis Indiana.

 

Position : Associate – Data Analytics, Medical Quality Organization

Location : Indianapolis, Indiana

Job id: R-33946

 

Job Details

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 35,000 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.Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description:The purpose of the Data Analytics Consultant, Medicines Quality Organization (MQO) role is the quality consultant for guiding the business to ensure Lilly effectively monitors Quality risks across research and clinical organization, ensuring regulatory compliance and minimizing risks to patient safety and study integrity. The Consultant actively develops and implements analysis, visualization, and business interpretation solutions and provides quality surveillance to identify business and quality risks and risk mitigation solutions. The Consultant proactively communicates risks with cross-functional teams to strengthen the quality of Medical Research, Safety and Efficacy Quality System effectiveness, and the integration of quality into business processes with a focus on data integrity. Based on the situation, the Consultant will be responsible for the implementation of quality initiatives. 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.Functional and Technical ExpertiseAccountable for the development/implementation of the quality monitoring technical solutions to monitoring procedural compliance, identify quality risks, their root causes, and the rate of success of historically implemented risk mitigation initiatives.Innovate/update technical solutions to integrate and interrogate text-based data sources to develop quality trending/monitoring/issue identification that meet business partner needs.Utilizes broad understanding of clinical development to identify root causes for quality risks and innovates solutions to continuously enhance monitoring capabilities.Utilizes risk-based program testing methodologies to ensure quality data output from technical solutions.Performs on-going quality state monitoring to identify performance/compliance gaps relative to current regulations and company standards, guidelines and internal procedures and recommends robust corrective actionsActively provides quality monitoring insights across multiple functions and levels of leadership to influence investment in strategic quality initiatives. Works with the business to establish control parameters to understand when processes and/or procedural compliance is at risk.Analyze business processes to determine innovative approaches which create significant added value to the businessInfluence Quality DirectionLeads the direction of quality and works cross-functionally to ensure regulatory and internal procedural compliance. Integrates across functions to maintain knowledge of current events, understand trends, and gain connection with business partners.Provides technical input to help influence the direction of technical initiatives that can enhance quality state monitoring.Works closely with management and functional teams to resolve complex issues. Influences complex regulatory, business or technical issues within a business area and/or functionUtilizes quality experience to support change management and business transformation in the delivery of the portfolio.Problem SolvingLeverages experience delivering work products, Clinical Data, and technical capabilities to discern problem, translate issues, and facilitate problem solving. Build CAPA action plans and monitors effectiveness.Leads teams in the process of resolution of issues; including resolution of conflict and building an environment to focus on the expedited resolution of issues. Escalates issues and manages the interfaces to ensure issues are well researched, understood and resolved.Technical Leadership & Decision MakingPrograms and tests clinical data reports, dashboards and analytics in a manner that allows for seamless downstream consumption, standardization and integration of data.Understands end-to-end data programming, testing, data technology, data flow, and data standards.Collaborates with clinical data experts and key stakeholders to deliver standardized reports, dashboards and innovative analytic solutions for use in global clinical trials.Provides key data (compliance, conformance, risks, issues) to senior management to drive decision making in support of data decisions and/or the portfolio.Leads, consults and performs root cause analysis.Key resource in the development of gathering business reporting requirements and developing a reporting process in-line with the business partners needs. Shares key learning’s to drive simplification and replicate best practices – drives quality into the business.Customer/External FocusLeads the development of quality agreements internally and external parties and alliances. Interacts with regulators, customers or other outside stakeholders on business issues.Acts as quality expert consultant to the business and external parties. Builds relationships with internal and external customers and partners.Works closely with MQS consultants, Training, Business Process Management and other areas to ensure there is awareness of systematic issues and compliance concerns. Works as part of a cross-functional team to develop effective systems and processes.Maintains external focus, exchange with counterparts or competitors and is key member (leader) of external committees (pharma and/or quality).Basic Qualifications:Bachelors Degree or above in data analysis, analytics, statistics, or informatics or demonstrated equivalent experienceAt least 3 years experience in data sciences, data analysis, and/or qualityExperience with database concepts, text-mining and visualization developmentAdditional Preferences:Advanced degrees preferred but not essentialStrong knowledge of quality systemsDemonstrated ability to operate within large global organizationsProject management experience.​Demonstrated ability to present complex data and concepts to broad audiencesGlobal perspective and working across functional and geographical boundariesDemonstrated understanding of quality management system principles, including policies, procedures and processesDemonstrated ability to identify root cause and manage difficult global business/quality issues. Ability to separate critical from non-critical issuesThorough knowledge of quality systems applicable to all areas of medical researchDemonstrated understanding of IT solution development and testing requirementsExcellent communication (written and verbal), interpersonal, organizational and negotiation skills.Additional Information:15% travel requiredEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). #WeAreLilly

 

 

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