At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Title: Advisor- E&C-LRL
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Provide Ethics and Compliance (E&C) leadership to senior leaders across Discovery/Research, Medicines Development Unit and to the overall global LRL organization. This role will report to the Ethics and Compliance Officer, LRL and Loxo Oncology @ Lilly (LO@LLY).
The scope of the role is focused on enabling the organization’s adherence to Lilly’s Code of Conduct as defined in The Red Book as well as all applicable US laws, regulations, and industry codes of conduct (US, EFPIA, and IFMPA), including the FD&C Act (as related to promotional activities), FCPA, PDMA, Anti-Kickback laws, False claims act, and OIG guidance. This role will help deliver on the E&C mission to drive the integration of high performance with high integrity across the organization, accomplished through providing Ethics and Compliance guidance, effective compliance business partnering, and solution-oriented compliance advice on overall business strategies, decisions, and activities conducted within LRL and/or overseen by LRL and through implementation of the 7 elements of an effective compliance program as defined by the OIG.
This position will be the primary point of contact for all functions across LRL and will coordinate compliance support with other areas in Global Ethics and Compliance (such as Business Unit Ethics and Compliance, E&C Operations, and the geographies). This role provides technical leadership, setting the strategy and direction within E&C to enable the implementation of an effective compliance program in LRL and connecting to the various LRL/R&D sites. As part of this organizational responsibility, the advisor is also responsible for developing and implementing operations necessary to ensure reporting and monitoring requirements are meet. This role coordinates with Quality, Legal and/or HR to support any Corrective/Preventative and Disciplinary Actions resulting from compliance failures. Regular networking with quality, audit, legal and regulatory as well as with compliance colleagues internally and externally is essential to ensure alignment with company policies and compliance objectives. This role also participates as a member of the relevant leadership teams (e.g. Research and Development, Bioethics Advisory Committee).
- Through effective partnership with LRL leadership, and oversight by LRL E&C, ensure business discussions and decisions encompass and consistently take into consideration appropriate ethics and compliance elements, and that there is clear business ownership of ethics in all decisions taken.
- Ensure that E&C program elements are appropriately tailored to LRL activities and operations, enabling the business to meet business goals in an effective and compliant manner and foster agility and innovation.
- Deliver effective compliance business partnering, and solution-oriented compliance advice on overall business strategies, decisions, and activities conducted within LRL and/or overseen by LRL; including providing recommendations of ways to mitigate or resolve potential E&C risk throughout LRL functional areas.
- Influence leadership through effective communication of the external environment and internal policies/standards.
- Collaborate with leadership to ensure the key elements of an effective compliance program are built into local governance and decision forum, business and operational processes, and training and appropriately tailored to LRL activities and operations, enabling the business to meet business goals in an effective and compliant manner.
- Lead E&C activities associated with research and development. Given next generation development, new/evolving R&D sites, innovation goals, new clinical trial strategies and an increasing range and scope of partnerships/collaborations, ensure reliable controls are in place and understood – i.e. ensure clarity in both the ‘what’ and the ‘why’ so that business activities are implemented appropriately. This includes supporting and consulting with various programs/teams and Business Development E&C.
- Analyze and identify program and business risks. Work with LRL leadership and functional areas to develop and implement monitoring program and compliance assessment activities. Follow up appropriately with root cause analysis and meaningful corrective actions/preventive actions.
- Effectively communicate the ‘state of control’ to the leadership teams. Foster open communication and feedback from leadership teams to ensure suggested controls are a good fit for the remit and mitigation of risks at LRL.
- Drive effective implementation of the compliance program through the business.
- Accountable for follow up on audit findings as appropriate to the E&C function.
- Ensure LRL Ethics and Compliance needs are reflected in the support plans of corporately based Ethics and Compliance groups (such as Central Operations, Policy Center of Excellence, etc.)
- Ensure an open and collaborative environment that promotes teamwork, open communication, and collaborative interactions among team members and with the broader LRL site leads.
- Provide input into development of Corporate Compliance Policies and Procedures that reflect the needs and remit of LRL.
- Ensure business processes and operational procedures are consistent with Global Policies and Standards.
- Provide compliance support as needed for investigations of non-compliant activities and appropriate corrective action/disciplinary steps.
- Bachelor’s degree
- 5+ years of experience in global research & development, clinical development or medical affairs.
- No documented compliance violations within the last 12 months.
- Experience working in highly matrixed organizations – across therapeutic areas, business units, functions and geographies
- Demonstrated ability to communicate effectively.
- Demonstrated ability to influence at all levels of leadership in the organization and demonstrated ability to network internally and externally to influence without authority.
- High level of professional maturity and sensitivity to confidentiality.
- Position requires some domestic and international travel.
- Strong leadership skills (people development, critical thinking, results oriented, etc.), including a strong reputation for integrity and sound judgment.
- Ability to translate ambiguity and complexity into a meaningful, actionable framework.
- Willingness to challenge and speak up.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.