• Research compliance program benchmarks, maturity measures, and other requirements • Design and/or enhance organizational code of conduct • Write, edit, or maintain compliance policies, procedures, and program descriptions • Construct specific and effective compliance training and education • Establish and enforce timely reviews of business owned policies and procedures • Create and manage policy & procedure workgroup initiatives • Assist with compliance vendor oversight activities • Create compliance communication plans that increase workforce engagement • Write and track compliance program responses to client requests for proposal/information (RFP/RFI), questionnaires, and other attestations • Develop job aids, playbook, and other program documentation • Build and maintain positive and strategic relationships with internal and external stakeholders • Support our compliant and ethical culture • Assist in developing or updating oversight materials and reporting metrics • Abide by organization retention standards and version controls • Investigate potential or reported issues of non-compliance • Perform root-cause analysis and identify prevention, detection, and correction opportunities • Ensure business partners complete corrective actions in a timely and effective manner • Monitor organizational disciplinary actions and incentives for consistency, accuracy, and timeliness • Collaborate with Legal and other stakeholders to interpret regulations • Other responsibilities as assigned

• Design and/or enhance targeted and annual risk assessments • Develop risk methodologies, scoring, and prioritization • Construct specific and effective auditing and monitoring workplans based on risks identified • Perform timely auditing and monitoring activities • Analyze compliance outcomes and ensure detected issues are referred for remediation • Identify ways to mitigate risks to our organization • Coordinate external audits, as assigned • Create and run mock audits • Build and perform readiness testing exercises • Develop job aids, playbook, and other program documentation • Build and maintain positive and strategic relationships with internal and external stakeholders • Support our compliant and ethical culture • Assist in developing or updating oversight materials and reporting metrics • Create and distribute written compliance standards where applicable • Abide by organization retention standards and version controls • Collaborate in Compliance training and education needs • Investigate potential or reported issues of non-compliance • Perform root-cause analysis and identify prevention, detection, and correction opportunities • Ensure business partners complete corrective actions in a timely and effective manner • Monitor organizational disciplinary actions and incentives for consistency, accuracy, and timeliness • Collaborate with Legal and other stakeholders to interpret regulations • Other responsibilities as assigned

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents intended for submission to the Regulatory Authorities • Serve as representative of Global Regulatory Affairs at project team meetings • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintenance of project plans, project trackers and regulatory intelligence tools • Assist in development of Regulatory Affairs Specialists and other operational area staff • Provide input into regulatory strategy and timeline development for new study opportunities • Participates in maintaining and executing on the corporate quality initiatives

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees • Serve as representative of Global Regulatory Affairs at project team meetings • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintenance of project plans, project trackers and regulatory intelligence tools • Assist in development of Regulatory Affairs Specialists and other operational area staff • Provide input into regulatory strategy and timeline development for new study opportunities • Participates in maintaining and executing on the corporate quality initiatives across business units