Associate Director - Senior Case Manager

Eli Lilly and Company • Us, IN

5d • Onsite

About The Position

The Associate Director, Senior Case Manager, Case Management Operations is the senior hands-on practitioner for Individual Case Safety Report (ICSR) work across intake, case processing, and regulatory submission. The role resolves the most difficult case-level questions and promotes consistent case execution across Lilly and vendor sites. It serves as a working-level authority relied on by Case Management Operations leadership and process subject matter experts.

The position provides operational guidance on complex ICSR decisions, supports quality and compliance, assists with audit and inspection activities, and coaches case managers and vendor trainers. It also represents case processors in system testing and change activities, identifies opportunities for automation, and partners with internal and external stakeholders on process and system updates. The role is based in Indianapolis, Indiana, with 0–10% travel, and requires fluent written and spoken English.

Requirements

• Bachelor’s degree.
• Minimum 5 years of hands-on ICSR processing experience covering intake, data entry, and submission.
• At least 2 years reviewing or quality-checking the work of other processors.
• Fluent written and spoken English, with the ability to write clear case guidance for multinational teams.
• Qualified applicants must be authorized to work in the United States on a full-time basis; Lilly will not support or sponsor work authorization or visas for this role.

Nice To Haves

• Experience coaching and calibrating case processors across more than one site or vendor.
• Applied knowledge of ICSR reporting requirements, such as ICH E2B(R3), ICH E2D, EU GVP Module VI, FDA 21 CFR 314.80, and FDA 21 CFR 600.80, at the level of individual case decisions.
• Hands-on proficiency with a safety database, such as Argus or Veeva Vault Safety, and with MedDRA and WHO Drug coding.
• A track record of resolving complex validity, duplicate, and coding questions and clearly explaining the rationale to processors.
• Working proficiency in Excel for case volume and quality tracking, such as pivot tables and lookups.
• Previous experience with an outsourced or multi-vendor case-processing model.
• Prior work with case-processing capacity and throughput analysis.
• Previous experience handling device, combination product, or clinical trial serious adverse event (SAE) cases, including SAE reconciliation.
• Prior work with intake or case-processing automation tools.
• Proven ability to deliver case-processing work through a site transition or product routing change.

Responsibilities

• Serve as the key operational decision-maker for complex ICSR validity questions, including the four minimum criteria, unidentifiable reporters or patients, counterfeit and product-quality reports, reports with no suspect Lilly product, and case versus non-case determinations.
• Monitor operational metrics and trends, identify emerging risks, and ensure concerns are resolved or escalated, including issues found through quality review or raised by leadership.
• Resolve difficult, complex, duplicate, and linked-case scenarios, including parent–child and pregnancy cases or reports about the same patient from multiple sources, and confirm the correct master case.
• Support case management operations audits and inspections by providing case-level evidence and walk-throughs when requested, and perform root cause investigations and CAPA implementations.
• Coach case managers and vendor trainers on difficult case scenarios and help create and deliver shared learnings as needed.
• Serve as the escalation point for complex E2B acknowledgment rejections and submission failures that sites cannot resolve; determine the case-level root cause and correction approach.
• Advise Case Management Operations leadership on case-level factors behind backlog, throughput, and timeliness trends, and raise concerns to the strategic vendor management team with operational recommendations.
• Support calibration of ICSR quality reviewers so the same quality error is scored consistently across sites.
• Escalate systemic quality or compliance risks to the Case Management leadership team, as applicable.
• Serve as an escalation point for process SMEs and Case Management Operations managers on unresolved case decisions.
• Review Shared Learnings content prepared by product SMEs and case managers for accuracy and consistency before release.
• Represent case processors’ perspectives on the safety database and intake tools in user testing, defect triage, and change requests as needed.
• Identify manual, repetitive case-processing steps and document requirements for tooling or automation.
• Work with Clinical and Commercial Liaisons on intake channels and product-specific case-handling conventions.
• Provide operational input to Standards & Compliance when procedures affecting case processing are revised.
• Partner with internal and external stakeholders on process and system updates as needed.
• Provide case-level information requested by the EU QPPV office, such as case status and submission evidence.
• Perform other related duties as assigned.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior