More jobs:
Research Advisor
Job in
Indianapolis, Marion County, Indiana, 46202, USA
Listed on 2026-08-20
Listing for:
Lilly
Full Time
position Listed on 2026-08-20
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
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* Purpose:
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* The Environmental Risk Assessment group provides enterprise leadership for environmental risk assessments (ERAs) that support global regulatory submissions, environmental stewardship commitments, and strategic management of issues related to pharmaceuticals in the environment (PiE). Positioned within Lilly's research and development organization, the group applies scientific judgment to design fit-for-purpose testing strategies for portfolio assets and to anticipate evolving regulatory expectations.
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* Primary Responsibilities:
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* This scientific role leads the ERA Group and is accountable for the strategy, quality, and timely delivery of environmental studies and risk assessments that characterize the interaction of Lilly therapeutics with the environment. The group leader serves as a people leader, scientific leader, strategic consultant, and technical expert for PiE-related issues across Lilly's portfolio, manufacturing network, regulatory functions, and external engagement forums.
** Key Objectives:*
* Lead the ERA Group by setting scientific direction, developing environmental scientists, and building environmental risk assessment capability across the portfolio.
Own portfolio ERA testing, prioritization, study governance, and submission-ready delivery for global regulatory registrations.
Direct execution of environmental studies that meet regulatory expectations through fit-for-purpose CRO partnerships that ensure GLP compliance, data quality, and reliable report delivery.
Advance Lilly's diverse portfolio and ERA science by identifying and fostering innovative solutions and cross-functional collaboration.
Communicate ERA strategy, risks, decisions, and regulatory implications to Lilly leadership, project teams, and regulatory functions.
Advise manufacturing on pharmaceutical discharge limits and implementation strategies that protect people, ecosystems, and business continuity.
Lead PiE governance by assessing internal and external developments, framing business implications, and driving mitigation strategies through cross-functional partnership with GHSE, Governmental Affairs, R&D.
Represent Lilly externally to benchmark guidelines, influence regulatory expectations, shape industry positions, and guide external research engagement.
** Minimum Qualification Requirements:*
* + PhD in environmental or natural sciences, or related field
+ 15 years experience in chemical environmental risk assessment in pharmaceutical or pesticide industry and/or as consultant to such industries
+ Research experience in environmental toxicology and/or environmental fate
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Experience with OECD environmental studies and GLPs
+ Confirmed skills in scientific communication via published papers and presentations
** Other Information/Additional Preferences:*
* + Demonstrated effective cross functional and external influencing skills
+ Strong analytical and critical thinking skills and an ability to interpret data from environmental studies
Ability to organize and lead task teams to consensus deliverable
+ Strong understanding of the scientific method
+ Broad understanding of global environmental policies/issues and potential business implications especially those that impact pharmaceutical environmental risk assessment
+ Familiarity with pharmaceutical or pesticide risk assessment processes
+ Previous Pharma or Industry experience
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 ( ) 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include:
Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture…
Position Requirements
5+ Years
work experience
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