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.
Risk Management Technical Expertise
- Provide strategic guidance to product-specific cross-functional teams on optimal risk minimization strategies
- Support all risk management and risk minimization activities for assigned products including development and maintenance of RMPs, ARMMs, and REMs ensuring configuration with overall product strategy.
- Facilitate product-specific results to meet quality standards and timelines
- Provide risk minimization resources, tools, and expertise as needed to support the assigned product portfolio including support for risk minimization efficiency/assessment reports and additional PV activities.
- Collaborate with other GPS functions for tracking and reporting on product-specific metrics related to risk minimization efficiency and compliance
- Lead as subject matter expert responsible for Risk Management strategies across therapeutic areas and globally in collaboration with cross-functional teams including product development teams engage in key product team meetings and decision forums.
- Influence product teams in strategic decision-making regarding risk management approaches throughout the product lifecycle
- Guide clinical development teams on benefit-risk and risk management considerations during product development, including providing support on identifying benefit-risk assessment frameworks and visualization tools.
- Lead and support product-specific regulatory interactions related to risk management (e.g., health authority meetings, responses to regulatory questions).
- Facilitate product-specific results to meet quality standards and timelines.
- Drive solutions leading to consistency in tracking, documenting and presenting product-specific metrics and key performance indicators.
- Maintain and apply awareness of the global regulatory environment, including new regulatory guidance, product-specific risk management and risk minimization activities.
- Lead the coordination of large, multi-component, cross-functional product-specific activities with affiliates, partners, and third-party organizations (TPOs) in the design and implementation of RMPs and risk minimization activities.
- Proactively identify risks to product-specific risk management activities along with developing, delivering and communicating contingency plans to key collaborators.
- Support the monitoring and tracking of the implementation and execution of product-specific Risk Management activities globally in conjunction with the GPS quality group.
- Identify and champion opportunities for risk management strategy optimization based on accumulating product data.
- Identify and communicate dependencies and interdependencies across assigned product portfolio
- Establish and maintain regular communication with key GPS and business unit personnel for the assigned product portfolio.
- Advise and guide on product-specific risk management activities by collaboration with internal cross-functional customers, including medical affairs, regulatory, clinical development, commercial and regional/local affiliates, and external TPOs involved in the implementation of Risk Management projects.
- Collaborate with GPS pharmacoepidemiology on product-specific observational studies that support risk management objectives.
- Collaborate with other GPS functions on the oversight of post-marketing safety activities related to assigned products including risk minimization efficiency reports, REMS assessment reports, DSURs, PBRERs/PSURs, and ARMM efficiency reports.
- Perform as SME for Health Authority inspections and audits for assigned products within scope of risk management.
- Ensure utilization and consistency of detailed GPS processes and quality systems.
- Mentor and develop junior team members on technical and regulatory aspects of risk management and risk minimization through product work.
Enterprise Leadership
- Communicate effectively with internal and external partners to align priorities and drive informed decision-making.
- Support and lead maintenance of processes and tools to effectively communicate product-specific risk management information to all key partners, including senior management, governance committees, product team members, functions, business units, partners, and affiliates.
- Represent Lilly on selected external working groups related to risk management and benefit-risk assessment
- Influence developing initiatives (policies, practices, guidance, and regulations) at FDA, EMA, and other regulatory agencies
- Champion guidelines and lessons learned from product experience to improve organizational capabilities
Understand and Support the EU QPPV Role
- Demonstrate clear understanding of the roles and responsibilities of the EU Qualified Person and associated regulatory expectations.
- Provide support to enable the EU Qualified Person to fulfill their legal obligations.
Minium Qualification:
Preferred Qualifications:
- Advanced degree or equivalent strongly preferred with 3+ years experience in Clinical Development in scientific, health care for pharmaceutical industry.
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. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$115,500 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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