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 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.

　　Organization Overview:

　　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.

　　Associate Director/Director, External Collaborations will lead alliance partner relationships for Global Patient Safety (GPS) and Global Regulatory Affairs (GRA) operations and lead vendor management for GPS function. This role supports the management of safety information and regulatory strategy for Lilly marketed products and compounds in development.

　　Responsibilities:

　　Drive Pharmacovigilance/Regulatory partnership strategy

　　Define strategy for business partnerships as it relates to pharmacovigilance and regulatory affairs

　　Perform Due Diligence assessment for operational aspects for pharmacovigilance and regulatory affairs

　　Lead negotiations in alignment with strategies for acquisition, divestures, co-development/promotion, clinical collaboration, and distribution and promotion, and other agreement types

　　Transfer the agreed upon elements to coordinator for inclusion in PVA

　　Review Pharmacovigilance Agreement and associated documents, as required

　　Maintain up-to-date knowledge of regulations and processes within GPS and GRA

　　Lead Implementation of Pharmacovigilance/Regulatory partnership strategy

　　Lead implementation of partnership strategy with accountability for alliance performance measures

　　Develop and lead areas for integration and transition through influence and effective project management

　　Define and execute data migration in collaboration with cross-functional teams and IDS

　　Vendor Management across GPS

　　Establish framework for effective vendor management in defining good oversight and measures for monitoring to ensure compliance.Collaborate effectively externally and internally

　　Review and advise on term sheet/contract development for business partnerships, in-licenses and divestitures.

　　Develop and influence relationships with external parties, Lilly cross-functional teams, and EC team consistent with Team Lilly behaviors

　　Serve as point of escalation and effectively communicate with business partners, key stakeholders, and Lilly cross-functional teams

　　Guide affiliate PV teams regarding local partnership agreements

　　Train GPS and GRA representatives on due diligence themes

　　Participate and support audits and inspections (internal, external party, or regulator audits and inspections)

　　Basic Requirements:

　　Bachelor’s degree in business, healthcare, life sciences, and/or legal fields or demonstrated equivalent experience is required.

　　Proven expertise in the Pharmaceutical industry, minimum 5 years’ experience in one of the following areas; Pharmacovigilance, Regulatory, Business Development or Clinical Development.

　　Additional Preferences:

　　Experience with contracts/agreements and negotiation with external parties

　　Managing external relationships through effective alliance and vendor management and understand rules for maintaining confidentiality and materiality.

　　Highly effective communication, inclusive of active listening both written and verbal.

　　Ability to influence without direct authority over others

　　Demonstrated success in team-based, cross-functional project management (scope, timeline delivery, risk management, prioritization, communication planning)

　　High degree of learning agility and flexibility in a dynamic environment

　　Ability to make risk-based decisions in timely manner

　　Attention to detail and problem-solving skills.

　　Proficient computer skills (Microsoft Suite of Apps, Word, Excel, PowerPoint, Project, Visio)

　　Fluency in English – written and verbal

　　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 ( [email protected] ) 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.

　　Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

　　Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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