All Of Our Groups
Healthcare
AssociateDirector/Director–RiskManagementScientist
“Associate Director/Director – Risk Management Scientist at All Of Our Groups. Skills: Risk Management, Risk Minimization, Regulatory Affairs. Provide strategic guidance on risk minimization strategies. Support risk management activities for assigned products”
Industry & Context.
Identify risks; Develop contingency plans; Optimize strategy
What They're Looking For.
Must Have
Bachelor's degree in scientific or healthcare related field, 5 years of experience in Clinical Development, 2 years of experience in patient safety
Nice to Have
Advanced degree strongly preferred, 3+ years experience in Clinical Development
What You'll Do.
Provide strategic guidance on risk minimization strategies
Support risk management activities for assigned products
Develop and maintain RMPs
Facilitate product-specific results to meet quality standards
Provide risk minimization resources
Support risk minimization efficiency/assessment reports
Support additional PV activities
Collaborate with GPS functions for tracking and reporting
Lead as subject matter expert for Risk Management
Influence product teams in strategic decision-making
Guide clinical development teams on benefit-risk considerations
Support identifying benefit-risk assessment frameworks
Support identifying visualization tools
Lead and support product-specific regulatory interactions
Respond to regulatory questions
Drive solutions for consistency in tracking metrics
Maintain awareness of global regulatory environment
Lead coordination of cross-functional product-specific activities
Design and implement RMPs
Implement risk minimization activities
Proactively identify risks to risk management activities
Develop contingency plans
Deliver contingency plans
Communicate contingency plans
Support monitoring and tracking of Risk Management activities
Identify opportunities for risk management strategy optimization
Communicate dependencies and interdependencies
Establish and maintain regular communication
Advise and guide on product-specific risk management activities
Collaborate with internal cross-functional customers
Collaborate with external TPOs
Collaborate with GPS pharmacoepidemiology on observational studies
Collaborate with other GPS functions on oversight
Oversee post-marketing safety activities
Oversee risk minimization efficiency reports
Oversee REMS assessment reports
Oversee ARMM efficiency reports
Perform as SME for Health Authority inspections
Perform as SME for audits
Ensure utilization of GPS processes
Ensure utilization of quality systems
Mentor junior team members
Develop junior team members
Communicate effectively with internal and external partners
Drive informed decision-making
Support maintenance of processes and tools
Communicate product-specific risk management information
Represent Lilly on external working groups
Influence developing initiatives at FDA
Influence developing initiatives at EMA
Influence developing initiatives at other regulatory agencies
Champion guidelines from product experience
Champion lessons learned from product experience
Demonstrate understanding of EU QPPV roles
Demonstrate understanding of EU QPPV responsibilities
Provide support to enable EU Qualified Person
Fulfill legal obligations
How You'll Work.
Team & Collaboration
Cross-functional teams; Product development teams; GPS functions; Business unit personnel; Internal cross-functional customers; External TPOs; GPS pharmacoepidemiology; Senior management; Governance committees; Product team members; Functions; Business units; Partners; Affiliates
Communication Scope
Executive presentations; Reporting
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