Associate Director - Case Management Standards and Compliance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. 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.  Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.   Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.   Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

The Associate Director - Case Management Standards and Compliance will be responsible for leading the development, implementation, and oversight of robust case management standards and compliance frameworks within Eli Lilly and Company. This role ensures adherence to global regulations, internal policies, and best practices related to pharmacovigilance and product complaint handling, safeguarding patient safety and maintaining regulatory integrity.

Lead the design, development, and maintenance of global case management standards, policies, and procedures, incorporating evolving regulatory requirements and industry best practices. Oversee the implementation and effectiveness of compliance monitoring programs for case management activities across all relevant functions and regions. Conduct regular audits and assessments of case management processes to identify potential compliance gaps, risks, and areas for improvement. Develop and deliver comprehensive training programs to ensure all personnel involved in case management activities are proficient in relevant standards, regulations, and systems. Act as a subject matter expert on case management compliance, providing guidance and support to internal stakeholders, including Pharmacovigilance, Quality Assurance, and Regulatory Affairs. Collaborate with cross-functional teams to investigate and resolve compliance issues, implement corrective and preventive actions (CAPAs), and monitor their effectiveness. Represent Eli Lilly during regulatory inspections and audits pertaining to case management, ensuring accurate and timely provision of requested documentation and information. Stay abreast of global pharmacovigilance regulations, guidelines, and industry trends to proactively identify and address potential impacts on case management compliance.