Associate Director - Senior Case Manager

Job Position Overview

The Associate Director, Senior Case Manager, Case Management Operations is the senior hands-on practitioner for Individual Case Safety Report (ICSR) work across the three operational pillars of Case Management Operations: intake, case processing and regulatory submission. The role settles the hardest case-level questions and keeps case execution consistent across Lilly and vendor sites. It is a working-level authority that Case Management Operations leadership and process SMEs rely on for case decisions.

Responsibilities

Intake, Processing and Submissions

• Act as the key operational decisionmaker on complex ICSR validity questions, including the four minimum criteria, unidentifiable reporters or patients, counterfeit and product-quality reports, and reports with no suspect Lilly product, as well as case versus non-case determinations.
• Monitor operational metrics and trends to identify emerging risks, and ensure timely resolution or escalation of concerns, including those identified through quality review or raised by leadership.
• Resolve difficult, complex, duplicate and linked-case scenarios (for example parent-child and pregnancy cases, or the same patient reported through several sources) and confirm the correct master case.
• Provide audit and inspection support for case management operations, including case-level evidence and case walk-throughs when requested, including performing the root cause investigations and CAPA implementations.
• Coach case managers and vendor trainers on difficult case scenarios.
• 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 and decide the root cause and correction approach at the case level.
• Advise Case Management Operations leadership on the case-level drivers behind backlog, throughput or timeliness trends, and highlight concerns to strategic vendor management team with recommendations of operational response.
• Support the calibration of ICSR quality reviewers so that the same quality error is scored the same way at every site.
• Escalate systemic quality or compliance risks to the Case Management leadership team, as applicable.

Escalation Support and Working-Level Guidance

• Be the escalation point for process SMEs and Case Management Operations managers on case decisions they cannot resolve.
• Review Shared Learnings content prepared by product SMEs and case managers for accuracy and consistency before release.
• Represent the case processor's view of the safety database and intake tools in user testing, defect triage and change requests, as needed.
• Identify manual, repetitive steps in case processing (for example repeated lookups or manually written narratives) and document the requirements for tooling or automation.

Cross-Functional Partnering

• Work with Clinical and Commercial Liaisons on intake channels and product-specific case handling conventions.
• Give operational input to Standards & Compliance when procedures that affect case processing are revised.
• Partner with internal and external stakeholders on process and system updates, as needed.

Perform other related duties, as assigned

• Provide case-level information requested by the EU QPPV office, such as case status and submission evidence.

Basic Qualifications

• Bachelor's degree
• Minimum 5 years of hands-on ICSR processing experience covering intake, data entry and submission, including at least 2 years reviewing or quality-checking the work of other processors.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Preferences

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

Additional Information

• Location: US: Indianapolis, Indiana
• Travel Percentage (%): 0-10%
• Language Requirements: Fluent written and spoken English, with the ability to write clear case guidance for multinational teams.

Additional information

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 Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $117,000 - $171,600

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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