Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.
This role is the key point of contact for key regulatory systems, such as the Elanco Regulatory Request Tracking System (ELRRTS), License Information Tool (e-LIF), and OneSource.
Functions, Duties, Tasks:
As the key point of contact for Global regulatory systems this role is accountable for providing system access, user-training, and onboarding support
Manage system master data, such as contact addresses, product lists, manufacturing sites, and resource documents
Handle system maintenance and coordinate system updates
Understand the needs of cross-functional business partners and generate periodic metrics to support their needs
Set system guidelines, generate and maintain system EFPs and hold others accountable for adherence to the established processes
Support continuous system improvement based on business partner feedback and requirements
Evaluate submitted information on incoming requests for accuracy and completeness and triage requests to the appropriate individuals/teams
Maintain relevant system functional assignment document and ensure it contains accurate, up-to-date information
Assign/Reassign ELRRTS tasks and set/change ELRRTS due dates and/or status
Work closely with cross-functional system user (e.g. ELRRTS Regional Requesters and Assignees, global Pharma RA for OneSource, global RAM network for e-LIF, etc.) to understand the business needs and trigger potential system adjustments as necessary
Participate in special projects which support increased efficiency and/or process improvement
Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training
Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
3 years of work experience in the pharmaceutical industry, drug development, regulatory affairs or IT;
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Effective communications (written/verbal), presentation and facilitation skills
Interpersonal savvy, with the capability to build strong relationships across a wide range of stakeholders
Continuous improvement mindset – delivering effective solutions with the user needs well defined & understood
Highly self-motivated and willing to proactively take on leadership roles within project teams
Demonstrated ability to initiate and drive change across an organization.
Demonstrated ability to negotiate solutions to complex technical challenges with cross-functional business partners
ability to negotiate solutions to complex technical challenges with cross-functional business partners
Ability to work in a virtual setting across different cultures and time zones
Domestic and International travel may be required.
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.