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. Advisor/Sr Advisor- Pharmacoepidemiology Purpose: The purpose of the Global Patient Safety Pharmacoepidemiology Scientist (GPS PE) is to provide pharmacoepidemiology leadership and technical support to the GPS Organization, Business Unit (BU) Teams, Value, Evidence and Outcomes (VEO), Affiliates, and other functional areas within the Company. As part of a cross-functional team, the GPS PE will have the following responsibilities: support the development and execution of risk management plans; identify and evaluate potential safety signals and address safety questions from regulators. The GPS PE will have primary responsibility for designing and conducting pharmacoepidemiology studies using appropriate methods and data sources; for understanding the natural history of targeted health conditions; and for collaborating with external research organizations. The GPS PE role may also entail some in-line or project-level supervisory responsibilities. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Global Patient Safety Support: Demonstrate knowledge of relevant global regulatory requirements and practices; act as subject matter expert in the development and maintenance of procedures and required tools in the quality system as they relate to epidemiology; provide pharmacoepidemiology support to GPS Surveillance Teams; demonstrate understanding of the roles and responsibility of the EU QPPV; support audit readiness; provide epidemiological expertise as it relates to signal detection and signal management for the portfolio. Support Risk Management Planning: Provide epidemiology expertise to support compounds in development, submission activities (including Post Authorisation Safety Study (PASS), new product launches, and existing marketed products; partner/collaborate with both BU Teams and GPS Medical Physician/CRS on the development of risk management plans. Contribute to the Risk Management Strategy/RWE Safety Strategy for a molecule. Design/execution/interpretation of pharmacoepidemiology studies including design and review of study protocols, SAPs, final study reports, presentations and manuscripts. Lead the conduct of the pharmacoepidemiology studies internally (when appropriate) and collaborate/contract with external investigators and CROs as needed; provide scientific expertise in interpretation and communication of results of pharmacoepidemiology studies; contribute to the design/execution/interpretation Risk Minimisation Evaluation Surveys and REMS. Characterize Natural History of Diseases: Provide support to BU Teams and GPS Physician/CRS with patient population data from the literature or other relevant data sources to understand the nature and burden of illness of various disease/conditions for which the Company is developing new products to treat or to prevent; Including support of Orphan Drug Applications (ODA), Pediatric Investigation Plans (PIP), and Pediatric Study Plans (PSP). Conduct and manage epidemiology studies to characterize disease trends, frequencies, incidence/prevalence, co-morbidities, outcomes, risk factors and treatments. Collaboration with Internal and External Customers: Communicate effectively with relevant internal business partners; collaborate with BU Teams and Regulatory Scientists as part of issue management teams and in preparation of responses to requests posed by regulatory authorities; support BU Teams regarding safety information requests and other safety activities; collaborate with external partners and participate on key external initiatives. Strategic Development of Analytic Tools: Develop analytic tools to support activities such as disease state characterization, signal detection, clarification, and evaluation utilizing multiple data sources (e.g., spontaneous, health claims and electronic health records); partner on the development of new standardized analytic methods for selected regulatory safety documents/submissions (e.g., PBRER/PSUR, ISS, product labels). Supervisory Responsibilities: The role may also entail line supervisory or contract-employee responsibilities for a small group of Epidemiologists, including implementation of organizational objectives, putting in place and ensuring execution of performance management and development plans, performance assessment, coaching, addressing human resource related issues, providing scientific guidance and project oversight, ensuring compliance with SOPs and regulations, implementation of functional coordination/standardization across projects, and building staff capacity or optimizing productivity. The supervisory responsibilities may require up to 25-30% of the epidemiologist’s time; the remaining 70-75% will focus on direct portfolio support and technical/scientific activities. Minimum Qualification Requirements: A PhD or DrPH in epidemiology. Ability to conduct epidemiology research including preparation of study protocols and statistical analysis plans. Competent in the independent analysis of data and interpretation of results from clinical and epidemiology studies. Excellent computer skills; knowledge of statistical software packages to analyze epidemiological data. Have strong analytic skills, oral and written communication skills, strong interpersonal and leadership skills, and able to work independently and as a team member to resolve a variety of drug safety issues. Other Information/Additional Preferences: Clinical background (e.g., PharmD, MD, RN). Experience conducting epidemiological studies. High-level knowledge of global regulations with respect to drug safety and adverse event reporting. High-level knowledge and good understanding of GPS policies. Ability to learn and apply technical knowledge to meet changing project needs. Flexibility and ability to prioritize work to meet interpersonal and scientific goals. Ability to balance multiple activities, prioritize and handle ambiguity. 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 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 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. #WeAreLilly #J-18808-Ljbffr
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 make a difference for people in the world over by discovering, developing, and delivering medicines that help people live longer, healthier, and more active lives. One of Lilly's most important corporate objectives is to improve patient outcomes. A key step in achieving this goal is to improve our relationship with external health care providers and health care organizations ensuring a positive experience across all touchpoints that include thought leaders, consultants, speakers, external stakeholders, and employees. Therefore, we must prioritize how we engage with health care providers through every touchpoint to ensure we are meeting the needs of the patients we serve. Global Business Solutions is a global partner that was born in finance and provides unique capabilities that enable Lilly to accelerate the value we bring to patients. It has evolved and expanded into diverse Business Service functions including CMS HCP Contract to Pay. The Customer Meeting Services HCP Contract to Pay (CMS) team supports Lilly Meeting Owners with meeting planning & oversight, HCPs contracts and payments execution, and the reporting of transfer of value (TOV) to enable compliance with the EFPIA Disclosure Code. The Lilly Meetings & Congresses teams provide support for Meetings Oversight, while the CMS teams located in the GBS complete Health Care Provider (HCP) contracting, payment, expense reimbursement, and compliance support. The CMS Team works cross-functionally with regular interaction with key business partners within the GBS and Global and International Meetings & Congresses network, along with other key connected functions in Lilly, in particular Global Transparency, Global Customer Operations (GCO), and Ethics & Compliance. Responsibilities: Provide excellent contracting and payment support to external Healthcare Professionals as well as internal affiliate business partners. Establish and maintain internal strategic partnerships with compliance, finance, and other functions to facilitate cross-functional work and positively impact customer experience. Be seen as a “go-to” information resource for Contracting to Pay queries from external HCPs and internal business partners. Provide excellent customer experience through the timely coordination & execution of HCP contract to pay processes for assigned country. Ensure adherence to Anti-Corruption requirements when interacting with and engaging HCPs. Ensure compliance with data capture requirements to support Lilly’s ToV Disclosure requirements. Review key metrics & communicate to stakeholders to ensure KPIs are being met & improved. Ensure efficient and effective issue resolution for queries escalated from CMS HCP Contract to Pay Expert Specialist. Effectively coach & mentor the CMS Expert Specialist to ensure they deliver excellence and compliance across key processes. Demonstrate business process expertise and be prepared to train/lead the team. Support global/regional CMS projects as required. Support the overall CMS team by providing cover for team members and training new team members. Demonstrate flexibility as this person will primarily be responsible for the French market but support on other markets will also be required. Basic Requirement: 3-4 years’ customer-facing experience with excellent communications & compliance skills. Bachelor’s Degree (or equivalent work experience). Fluency in English and French is a requirement; additional language an advantage. Experience in Sales Force, SAP P2P module, MS Office including Visio. Experience with Contracting systems an advantage. Additional skills/Preferences: Requires business and/or technical knowledge developed through education or experience. Ability to create impact at different levels: immediate peers and across teams. May lead small to medium projects with small to moderate risk. Requires analysis of possible solutions to solve and anticipate a range of day-to-day problems. Ability to respond flexibly and empathetically to customer needs. Ability to work in local/regional/global team environment and communicate effectively. Compliance: Demonstrate a strong compliance-oriented mindset & help build a strong compliance culture. Familiarize with all applicable process documentation & training materials. Ensure ownership for all applicable Operational controls and remediation for any deficiencies. People: Actively work with core team members, internal business partners, external support agencies, and Healthcare Professionals to build effective working relationships. Customer: Demonstrate excellence in all interactions with internal customers, business partners & external Healthcare Professionals. Focus on measuring & improving Healthcare Professional’s experience with the CMS process & teams. Continuous Improvement: Demonstrate a strong Continuous Improvement oriented approach. Actively work with core team members & Global and International teams to drive improvements for processes. Additional Information: Travel Percentage – Up to 10% international travel may be required. Note: When applying internally for a position, your current supervisor receives notification that you have applied. We encourage employees to discuss the opportunity with their supervisor prior to applying. Lilly 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. #WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. #J-18808-Ljbffr
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. Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 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, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself. What You'll Be Doing: We’re looking for a Security Engineer to bring fresh perspectives and bold solutions to our team. In this role, you’ll be instrumental in shaping how our organization provides secure, appropriate, and timely access to enterprise resources. You will be part of the Lilly Cybersecurity Identity and Access Management (IAM) team which is responsible for delivering and securing technology that supports the Lilly mission. In this role, you will partner with the various business, IT, and larger cyber security teams to ensure technology is designed and deployed securely and aligned with Cybersecurity and enterprise technology strategies. You will create technical specifications, design patterns, standards as code and security guidance across identity capabilities and services where needed. You'll be a key contributor in identifying key processes around the development of our security service and working to develop proactive approaches for support, deployment, and optimizations of security toolsets. How You’ll Succeed: As a Security Engineer, you will bring your technical experience to evaluate and select advanced IAM technologies to meet business and security requirements focused on authentication services and consumer identity. Drive and deliver the implementation and technical integration of identity technologies to meet business requirements. Understand the threat landscape with the ability to translate the general threats into relevant business and technical impacts. As a superb communicator with strong interpersonal skills, you will work and collaborate effectively on a team to define, design and implement identity capabilities and solutions. Focusing on our business partners, you will develop and implement technical solutions and capabilities in Identity that improve security while enhancing user experience. With a high level of curiosity, you’ll keep abreast of the latest developments in IAM technologies, security threats, and regulatory changes. Drive the adoption of innovative and creative solutions to address complex, global IAM problems. Collaborate with enterprise IT, architects and stakeholders to understand business needs and incorporate feedback into the IAM technologies and solutions. What You Should Bring: Technical experience across identity and access management technologies such as Entra ID, Active Directory and Okta. Understanding of authentication and authorization technologies and federated identity standards and protocols (multifactor authentication, certificate-based authentication, LDAP Kerberos, OAuth, SAML, OpenID Connect). Experience in designing, developing, implementing, and supporting enterprise-class security systems. Experience developing solutions with PowerShell, Python, NodeJS, PHP or other development and scripting languages. Critical thinking and analytical reasoning skills. Strong communication and presentation skills, and ability to adapt messaging for diverse audiences. Experience in addressing consumer data regulations and integrating regulatory and industry standards (ISO/IEC, PCI DSS, SOX, HIPAA, FDA, GDPR, CCPA) into cybersecurity designs. An understanding of common services used in cloud-based architectures, with experience in AWS and/or Azure, and awareness of cloud platform security and controls. Experience working in Agile teams and using tools such as Confluence and Jira. Your Basic Qualifications: Bachelor’s degree in Cybersecurity, Computer Science, Information Technology or related field. 3+ years demonstrated technical experience evaluating, designing, developing and supporting Identity and Access Management technologies and capabilities. 3+ years demonstrated technical experience with Entra ID. Lilly 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. #WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. #J-18808-Ljbffr
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. Path/Level: B1 At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. The Customer Meeting Services (CMS) team supports Lilly Meeting Owners with meeting planning & oversight, HCPs Contracts and payments execution and the reporting of transfer of value (TOV) to enable compliance with the EFPIA Disclosure Code. Responsibilities Be seen as a “go-to” information resource for Contracting to Pay queries both from external HCPs and internal business partners. Provide excellent customer experience through the end to end coordination & execution of the Contract to Pay process in a compliant manner. Ensure efficient and effective issue resolution across the Contract to Pay process. Ensure adherence to Anti-Corruption requirements when interacting with and engaging HCPs. Ensure compliance with data capture requirements to support Lilly’s TOV Disclosure requirements. Monitor daily operational dashboard to ensure compliance with pre-defined SLAs. Support global/regional CMS projects with focus on the Contract to Pay process. Support the overall CMS team by demonstrating flexibility in providing cover for team members. You may be required to support other markets, language requirements permitting. Personal Attributes Ability to handle complexity and utilize analytical skills, with attention to detail. Ability to proactively & effectively analyze & resolve problems. Ability to effectively prioritize and complete key tasks and deliverables. Able to respond flexibly and empathetically to customer needs. Ability to work in local/regional/global team environment and communicate effectively. Requirements: Experience and Education 2-3 years’ customer facing experience with excellent communications & compliance skills. Associates Degree (or equivalent work experience). Fluency in English language is essential. Additional Language is an advantage. Experience in Sales Force, SAP P2P module, MS Office. Experience with Contracting systems an advantage. Experience in CMS HCP C2P. Compliance Demonstrate a strong compliance-oriented mindset & help to build a strong compliance culture. Ensure ownership for all applicable Operational controls for your area. Additional Information Travel Percentage – Up to 10% international travel may be required. #J-18808-Ljbffr
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. Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. Main Purpose and Objectives of Position: The primary responsibilities of the Maintenance & Reliability – Principal Electrical & Instrumentation Engineer is to provide support, direction and subject matter expertise on electrical & instrumentation issues during start up and then on into normal operations. The principal engineer will be primarily focused on the instrumentation / calibration / regulatory side of the discipline. This person will be required to understand and own all aspects of our site calibration program and be able to talk to the site calibration programme to health authorities and regulatory bodies during audits. The principal engineer will also own and be responsible for all aspects of the instrumentation equipment installed on site, examples working on RCAi, safety / quality deviations, equipment upgrades, obsolescence, project support, MTBF etc. The engineer also reviews our current instrument equipment performance to prevent potential reliability issues & implement reliability monitoring programs to provide maximum availability of equipment. Equipment selection for new capital projects as well as equipment selection for re-capitalisation projects are at the forefront of what the engineer does while assessing the appropriate quantity of spare parts required. Key Responsibilities: Own the site calibration program. Own and be responsible for all aspects of the instrumentation equipment installed on site, examples working on RCAi, Safety / quality deviations, equipment upgrades, obsolescence, project support, MTBF etc. Work with and liaise with health and regulatory authorities. Initiate and roll out new site calibration strategies and directives. Provide engineering support to both maintenance and equipment owners in your area of expertise. Ensure maintenance program is appropriate for reliable operation of equipment. Provide training to Maintenance personnel on new equipment, methods & techniques. Follow up on issues identified by equipment owner or via the maintenance Preventative Maintenance program. Participate, raise, investigate & complete HSE & Quality observation/deviations write-ups as appropriate. Ensure the local maintenance procedures are in line with Global Engineering Standard & Engineering Best Practices. Ensure Job Plans, data sheets & data loaders for addition to the computerised Maintenance management systems (CMMS) are correct and contain sufficient detail. Lead reliability improvements to identify equipment obsolescence in advance to support planned replacement vs reactive replacement using existing & developing technologies. Identify & support continuous improvement initiatives to enhance the Maintenance program in the short & medium term to maintain a reliable plant. Analyse predictive & condition-based monitoring data to identify follow-up actions and prioritise implementation with equipment owners. Lead the development & contribute as SME, to site Specifications. Develop, Review & own Departmental SOP’s. Review Stores & Inventory levels of critical equipment. Carry out internal audits and periodic reviews of GMP activities to ensure compliance. Develop, review and own relevant SOP’s. Support and drive approved initiatives. Identify and lead continuous improvement initiatives to enhance maintenance program. Ensure job plans, data sheets etc are correct and appropriately detailed. Provide engineering support to team and site for all E&I related topics as needed. Support development of calibration standards for maintenance team. Own COD/MU program for site. Lead investigator on Maintenance Quality/Safety Deviations. Pre-Requisites: 5+ years experience in a maintenance/engineering role, ideally within the pharmaceutical industry. Demonstrated ability to act independently using good organisational skills. Proven ability to make good use of systems, procedures & processes. Working knowledge of relevant EU directives (e.g. ATEX, etc). Familiarity with the relevant national/international engineering standards (e.g. NSAI, NECI, NEC, IEC, ISO, CEN, ISA, CENELEC etc). Expertise in Troubleshooting and Equipment failure investigation. Familiarity with the Global Maintenance processes & procedures. Educational Requirements: Level 8 Degree in Electrical & Instrumentation Engineering or equivalent. Key Attributes: Demonstrated technical skills in area of expertise. Demonstrated ability to influence and to lead change. Demonstrated aptitude and interest for problem-solving. Demonstrated strong communication skills – oral and written. Demonstrated ability to write technical reports. Strong sense of customer focus and teamwork. Demonstrated willingness to collaborate with work colleagues. Proven flexibility to respond to equipment issues. Proven ability to work independently and without direct supervision. Demonstrated commitment to safety and quality in the workplace. Personal Considerations: At times it may be necessary to receive calls outside of normal working hours and if necessary, attendance may be required on site out of hours. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly 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. #WeAreLilly #J-18808-Ljbffr
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. At Lilly, we make a difference for people in the world over by discovering, developing, and delivering medicines that help people live longer, healthier, and more active lives. One of Lilly's most important corporate objectives is to improve patient outcomes. A key step in achieving this goal is to improve our relationship with external health care providers and health care organizations, ensuring a positive experience across all touchpoints that include thought leaders, consultants, speakers, external stakeholders, and employees. Therefore, we must prioritize how we engage with health care providers through every touchpoint to ensure we are meeting the needs of the patients we serve. Global Business Solutions is a global partner that was born in finance and provides unique capabilities that enable Lilly to accelerate the value we bring to patients. It has evolved and expanded into diverse Business Service functions including CMS HCP Contract to Pay. The Customer Meeting Services HCP Contract to Pay (CMS) team supports Lilly Meeting Owners with meeting planning & oversight, HCPs Contracts and payments execution, and the reporting of transfer of value (TOV) to enable compliance with the EFPIA Disclosure Code. The Lilly Meetings & Congresses teams provide support for Meetings Oversight, while the CMS teams located in the GBS complete Health Care Provider (HCP) contracting, payment, expense reimbursement, and compliance support. The CMS Team works cross-functionally with regular interaction with key business partners within the GBS and Global and International Meetings & Congresses network, along with other key connected functions in Lilly, in particular Global Transparency, Global Customer Operations (GCO), and Ethics & Compliance. Responsibilities: Be seen as a “go-to” information resource for Contracting to Pay queries both from external HCPs and internal business partners. Provide excellent customer experience through the end-to-end coordination & execution of the Contract to Pay process in a compliant manner. This includes the pre-contracting data management for the Healthcare Professional. Ensure efficient and effective issue resolution across the Contract to Pay process including the pre-contract data management aspects. Ensure adherence to Anti-Corruption requirements when interacting with and engaging HCPs. Ensure compliance with data capture requirements to support Lilly’s TOV Disclosure requirements, which may include supporting data correction and reporting queries from Global Transparency team pre or post publication. Monitor daily operational dashboard to ensure compliance with pre-defined SLAs. Support global/regional CMS projects with focus on the Contract to Pay process & pre-contracting data management. Support the overall CMS team by demonstrating flexibility in providing cover for team members and training of new team members. You may be required to support other markets, language requirements permitting, as the need arises and as deemed appropriate by your line manager. Basic Requirement: 2-3 years’ customer facing experience with excellent communications & compliance skills. Legal/Contracting/Travel & Meetings support experience an advantage. Associates Degree (or equivalent work experience). Fluency in English language essential. Additional Language an advantage. Experience in Sales Force, SAP P2P module, MS Office. Experience with Contracting systems an advantage. Additional skills/Preferences: Requires business and/or technical knowledge developed through education or experience using discipline and understanding of key business drivers. Be able to create impact at immediate peers level. May lead small projects with small risk. Effective and agile communications skills are needed. Requires analysis of possible solutions to solve and anticipate a range of day-to-day problems including standard and non-standard requests. Be able to provide support on solving issues, within a team or multiple teams over time. Ability to respond flexibly and empathetically to customer needs, managing their expectations effectively. Ability to work in local/regional/global team environment and communicate effectively with both internal business partners of all levels & disciplines as well as external Business Partners. Compliance Demonstrate a strong compliance-oriented mindset & help to build a strong compliance culture. Familiarize with all applicable process documentation & training materials to ensure you operate in a fully compliant manner. Ensure ownership for all applicable Operational controls for your area as well as the remediation for any deficiencies and the sharing of all learnings across the team. People Actively work with the core team members, internal business partners, external support agencies, and Healthcare Professionals to build effective working relationships. Customer Demonstrate excellence in all interactions with our internal customers, business partners & external Healthcare Professionals. Focus on measuring & improving our Healthcare Professional’s experience with the CMS process & teams. Continuous Improvement Demonstrate a strong Continuous Improvement oriented approach & help to build a strong Continuous Improvement culture. Actively work with the core team members & Global and International teams to drive improvements for processes. Additional Information Travel Percentage – Up to 10% international travel may be required. Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. Lilly does not discriminate on the basis of age, race, colour, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. #J-18808-Ljbffr
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. Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 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, Age & Culture, LGBTQ+ 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. What You'll Be Doing: Ready to put your mark on the world of cybersecurity? We’re looking for a Security Engineer to bring fresh perspectives and bold solutions to our team. In this role, you’ll be instrumental in shaping how our organization provides secure, appropriate, and timely access to enterprise resources. You will be part of the Lilly Cybersecurity Identity and Access Management (IAM) team which is responsible for delivering and securing technology that supports the Lilly mission. In this role, you will partner with the various business, IT, and larger cyber security teams to ensure technology is designed and deployed securely and aligned with Cybersecurity and enterprise technology strategies. You will create technical specifications, design patterns, standards as code and security guidance across identity capabilities and services where needed. You'll be a key contributor in identifying key processes around the development of our security service and working to develop proactive approaches for support, deployment, and optimizations of security toolsets. How You’ll Succeed: As a Security Engineer, you will bring your technical experience to design and support Lilly Internal Certificate Authority & Certificate Management Service, Public Certificate provisioning service, and Digital Signature Service. Using your problem-solving skills, you will strive to quickly identify opportunities for service enhancements and facilitate escalation of critical technical issues and incidents for encryption services. Understand the threat landscape with the ability to translate the general threats into relevant business and technical impacts. As a superb communicator with strong interpersonal skills, you will work and collaborate effectively on a team including with remote team members, to define, design and implement Identity services and technologies. Focusing on our business partners, you will develop technical solutions in Identity that improve security while enhancing user experience. With a high level of curiosity, you’ll maintain technical knowledge across security concepts and technologies with a drive to expand knowledge across Identity. Works closely with partners inside and outside of Information Security, you will identify opportunities to use technology to solve information security and business problems. Within the Identity domain, you will identify technical solutions and drive implementation to support the strategic direction for the value, impact, risk mitigation, security controls, privacy controls, detection, response and quality. What You Should Bring: Knowledge of fundamental security principles. Skill in using Public-Key Infrastructure (PKI) encryption and digital signature capabilities into applications (e.g., S/MIME email, SSL traffic). Knowledge of electronic signature services (e.g., Adobe Sign). Possession or ability to achieve Microsoft Certified: Identity and Access Administrator Associate certification. Experience developing solutions with PowerShell, Python, NodeJS, PHP or other development and scripting languages. Knowledge of cloud hosting environments such as AWS & Azure. Experience working in Agile teams and using tools such as Confluence and Jira. CIAM, CIST, CISSP or equivalent certifications. Your Basic Qualifications: Bachelor’s degree in Cybersecurity, Computer Science, Information Technology or related field. 3+ years demonstrated technical experience evaluating, designing, developing and supporting Identity and Access Management technologies and capabilities. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly 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. #WeAreLilly #J-18808-Ljbffr
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. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 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, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. The role The Capital Procurement Associate Director for major capital project delivery and category management support is responsible for supporting the Manufacturing Component's need for sourcing suppliers for automation, construction, engineering, and engineered equipment with a principle focus on Europe and Asia. The role is part of the Global Manufacturing Procurement Capital & Infrastructure team which is responsible for sourcing and purchasing goods and services in a way that adds value to the internal client organizations and ensures Lilly remains competitive in the global pharmaceutical industry. In performing this role, the individual will utilize the Lilly Strategic Sourcing Process to provide the customer the greatest value within the allowed timeframe. The ideal candidate will have proven experience leading major capital projects; identifying/evaluating potential suppliers; executing work with engineering, architecture and construction management firms and negotiating domestic and international supply agreements. This includes experience managing internal relationships to facilitate capital project delivery as well as supplier relationships and performance to develop and implement cost effective sourcing strategies for each area that reduce supply risk. Key Responsibilities: Category management which consists of global development, implementation, and management of Lilly’s strategy for the acquisition of engineering and construction services, automation, and capital equipment. Lead the review of requirements, development of sourcing strategies, and management of the supplier due diligence process, oversight of the RFP process, contract negotiation and award, and oversight of the contract management process. Work in conjunction with business clients to qualify suppliers, participate in supplier relationship management meetings, spend analysis, market intelligence and risk management. Sourcing for major capital projects at Lilly’s global manufacturing sites to acquire goods and services ($100 - $750MM annually). Leads the procurement management for major projects and programs with greater risk, resource/financial requirements and/or complexity. Execute the supplier management which consists of facilitating the relationship between internal customers and suppliers. Identify and implement cost/risk reduction and avoidance savings opportunities of $15M or more annually. Execute project procurement activities in accordance with both Global Procurement procedures with strong focus on competitive bidding, ensuring recommendations are based on the most competitive technical and commercial acceptable sources. Essential Skills: Proven track record in sourcing engineering and construction services, capital equipment and experience with commissioning/qualification. 7-15 years in capital project procurement experience. Pharmaceutical process or plant experience preferred. Good communication skills – written, verbal, collaboration, and interpersonal. Willingness to influence and negotiate internally and externally. Demonstrated business acumen: good analytical and problem-solving skills. Self-motivated individual with the ability to act independently with minimal supervision in a complex multi-organizational environment while maintaining prioritization and ensuring appropriate level of compliance with policies and procedures. Education Requirements: Degree level of education in Procurement, Engineering, Manufacturing, Supply Chain Business related field or Degree level education in any discipline with relevant experience. Excellent command of written and spoken English. CIPS / IIPMM / ISM qualification and/or relevant Procurement experience. Good IT literacy with the Microsoft Office suite & SAP/Ariba. Other Information: Ability to travel 2 – 3 weeks per year (both internationally and domestically) as needed to support sourcing initiatives and supplier relationship management activities. Location: Cork, Ireland 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 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 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. #WeAreLilly #J-18808-Ljbffr
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. At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges. 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 patients around the world. Eli Lilly Cork is made up of a talented diverse team of over 2,000 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, subsidized 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, Age & Culture, LGBTQ+ 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 CMC Pre-approval Principal Regulatory Scientist supports the various aspects of clinical trials and marketing authorization submission management processes. The CMC Pre-approval Principal Scientist manages submission content for Drug Substance and Drug Product, and responses to questions. The CMC Pre-approval Regulatory Scientist in partnership with the GRA-CMC Regulatory Scientist provides tactical and operational direction to expedite CMC development of Lilly’s portfolio and technical agenda by supporting clinical trial and market registration submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes. The CMC Pre-approval Regulatory Scientist is responsible for networking with RDE CMC Regulatory Associates to ensure proper communication and adherence to workflows to deliver on time submissions and responses to questions. Primary Responsibilities: Plan and prepare submission content and responses to questions for clinical trials and marketing authorization applications. Manage internal requirements and documentation within GRA and with internal Lilly partners (Development, TS/MS, Quality, etc). Develop, plan and execute appropriate regulatory strategies and agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives, such as development, TS/MS, and quality. Manage submission timelines with relevant teams (e.g., development, TS/MS, clinical teams), monitor approval status and communicate change status to interested personnel in a timely manner. Partner with RDE CMC Regulatory Associates to effectively support clinical trial and product submissions. Lead, Influence, Partner: Create an environment within the Global Regulatory Area and across CMC teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues. Leverage internal forums to continue to develop and share regulatory expertise to meet critical clinical trial submissions/product registration timelines and electronic submission structure and content requirements. Communicate effectively to guide and influence within work group/function regarding life-cycle management processes. Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies. Minimum Qualification Requirements: Bachelor’s degree in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences or similar) with 6 – 8 years experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing or quality. Or master’s degree in regulatory affairs or in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences or similar) with 3 – 5 years experience in drug substance or drug product development, commercialization, manufacturing or quality. Less experience would be considered with a Pharm D or a PhD degree in a related field. Other Information/Additional Preferences: Pharmaceutical industry experience in CMC technical drug development desirable. Prior experience authoring CMC submission content is desirable. Prior Regulatory CMC experience or equivalent combination of technical and regulatory guidance knowledge is desirable. Demonstrated strong written, spoken and presentation communication skills. Demonstrated negotiation and influence skills. Demonstrated attention to detail and ability to prioritize effectively. Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Lilly 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. #WeAreLilly #J-18808-Ljbffr
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 patients around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Lilly 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. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! Purpose: The Associate Director, Clinical Trial Patient Engagement & Diversity Capabilities is responsible for overseeing the daily operations of Engagement & Diversity Capabilities including Health Literate Content, Graphic Design & Animation, Co-design and Services Management team. They are accountable for forecasting and managing resources to deliver business requirements; including recruiting, developing and overseeing a team of individuals with diverse experiences and ensuring they deliver outputs on time to inform business decisions, optimized for value, speed and delivered within budget. Additionally, the Associate Director must foster collaboration within the team, facilitating the timely sharing of best practices to be applied across programs and vendors. They will work closely with leaders in Patient Engagement, Clinical Capabilities, and the CDDA organization to develop talent with broad drug development experience. It is essential to promote a culture of quality and inspection readiness, driving decisions for the timely and optimized delivery of Lilly assets. Primary Responsibilities: Strategic and Technical Leadership: Accountable for providing strategic, technical and operational direction to a diverse team and ensure that processes for the assigned area(s) of focus (e.g., novel recruitment, patient-facing content) are well integrated within the appropriate Clinical Design Delivery & Analytics (CDDA) functions. Oversee that the team effectively provides value through strategic and technical expertise in the creation of right-sized design strategies, including a successful transition to delivery. Accountable for ensuring collaboration cross-functionally to successfully deliver work expectations/deliverables, including but not limited to Procurement, Investigator Engagement, Quality, Tech@Lilly, etc. Proactively assess and advise CT PE Senior Director of emerging technical needs or potential changes in strategic direction. Enterprise Leadership: Responsible for fostering a culture of team partnership and shared learning to identify best practices and standardized approaches to drive efficiency and optimized value. Responsible for ensuring the team collaborates within the team and across Clinical Capabilities and the CDDA to learn broadly about drug development and evolving business practices, share learnings/best practices and standardize/automate processes/tools/outputs to drive impact and efficiency. Responsible for engaging with the Patient Engagement Leaders to continuously assess business needs, ensure innovative and timely delivery of business expectations that meet or exceed expected metrics and value. Personnel Management and Development: Responsible for recruiting, developing and retaining an innovative, clinically focused and operationally capable workforce skilled and knowledgeable in the recruitment and retention of patients/caregivers in clinical trials, gathering and distilling insights from patients/caregivers/health care professionals across Lilly’s therapeutic areas and associated assets. Responsible for building a team culture that is inclusive, representative and fosters innovation. Responsible for developing staff who demonstrate expertise in drug development, therapeutic area science, project management, cross-functional engagement, and judgment-based decision-making. Responsible for establishing and maintaining a flexible staffing strategy to support changing portfolio needs. Responsible for facilitating performance management, personnel development, and career development through frequent interactions, coaching, transparent feedback, and escalation of issues as appropriate. Responsible for ensuring staff compliance with Lilly Corporate, Medical, Regulatory and other standards, procedures, and other internal and external business requirements, including training requirements. Basic Requirements: Bachelors Degree in scientific, health or business related field. Minimum of 5 years experience in pharmaceutical industry. Previous supervisory experience. Demonstrated strong leadership skills. Strong interpersonal and excellent communication (written and verbal), organizational and negotiation skills. Demonstrated ability to influence team members and extended team members. Additional Skills/Preferences: Advanced (Masters or PhD) degree in scientific, health or business related field. Broad understanding of the pharmaceutical drug/device development process. Demonstrated ability to take strategic knowledge and effectively influence the direction of daily operations. Prior experience in managing complex/cross-functional projects. Experience leading teams through transformational change. Prior project management experience and/or experience leading multi-disciplinary teams. Minimal travel required. Additional Information: Position is located in Cork, Ireland. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Lilly 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. #WeAreLilly #J-18808-Ljbffr
