Director - Case Management Medical Review at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in conducting comprehensive medical review of Individual Case Safety Reports (ICSRs) across all therapeutic areas
Knowledge of SOPs for clinical trial (CT) and marketed product (MP) cases
Ability to ensure medical validity, accuracy of narratives, coding, and assessments of seriousness, expectedness, and causality
Capability to identify, escalate, and monitor potential emerging safety concerns and quality issues
Strong cross-functional collaboration skills with teams in case management, audit/inspection readiness, regulatory responses, and causality assessments
Familiarity with GPS surveillance terms for marketed products and development pipeline
Leadership skills to influence cross-functionally, provide medical/regulatory guidance, training, coaching, and mentorship
Ability to develop cross-functional foundations (e.g., aggregate review, signal detection, Safety Topic Reports, regulatory requests, protocol authoring)
Skills in driving scientific/process improvements, organizational change, and maintaining a positive working environment
Operational management abilities: coordinate/monitor workflows, track KPIs/capacity, analyze trends/risks, propose solutions, manage meetings/action items, prioritize resources via financial/capacity analysis
Expertise in enhancing processes, ensuring audit readiness, and training medical reviewers
Proficiency in authoring/reviewing/approving SOPs, supporting process training/implementation
Readiness to serve as point of contact for Health Authority Inspections/Internal Audits, participate in back/front rooms, and prepare responses

Responsibilities

Conduct comprehensive ICSR medical reviews, ensuring high-quality outcomes, medical validity, accuracy of narratives/coding/assessments, and adherence to regulatory timelines/SOPs
Complete medical review and follow-up of ICSRs for CT and MP cases
Promptly escalate significant cases/safety issues and monitor ICSRs for emerging safety concerns
Identify/support evaluation of potential quality issues with Lilly products affecting patient safety
Collaborate with cross-functional teams on case management, audit/inspection readiness, regulatory responses, and causality assessments
Liaise with GPS teams to monitor/update on surveillance terms for marketed products
Develop cross-functional foundations (e.g., aggregate review/signal detection, Safety Topic Reports, regulatory requests, protocol authoring)
Influence cross-functionally and within function to meet objectives, safeguard patient safety, and maintain positive environment
Provide medical/regulatory guidance, training, coaching, mentorship to GPS scientists/physicians; identify gaps/retraining needs
Remain informed on marketed portfolio and development pipeline
Drive scientific/process improvements and contribute to organizational change
Coordinate/monitor workflows for timely/compliant case reviews
Track capacity/KPIs, analyze trends, identify risks, propose solutions for leadership
Drive meeting agendas, manage action items, ensure follow-up
Support prioritization/resource optimization via financial/capacity analysis
Enhance processes, ensure audit readiness, enable training for medical reviewers
Author/review/approve SOPs; support/lead training/implementation of processes
Act as point of contact for Health Authority Inspections/Internal Audits; participate in back/front rooms, prepare responses

Skills

ICSR

Medical Review

Pharmacovigilance

Safety Reporting

Regulatory Compliance

Medical Coding

Causality Assessment

SOP

Therapeutic Areas

Case Management

Global Patient Safety

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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