Senior Compliance Specialist
Assists Compliance Officer of Global Monitoring and Investigations in the development, implementation and management of compliance monitoring and investigations program. Executes ongoing compliance monitoring activities across the Company. Monitors promotional and non-promotional activities, including conducting live monitoring (e.g., routine sales calls and speaker program assessments) and transactional reviews (e.g., review of call notes and/or emails) related to the interactions of Sales and Marketing, Medical Affairs and Commercial Operations with Healthcare Professionals. Makes recommendations and contributes to the development of compliance monitoring plan architecture, tools, and programs based on findings and constant assessment of risk. Assists with conducting and documenting compliance investigations, and management of Ethics Hotline. This position will also be responsible for developing reports and communications in support of remediation activities, training needs and interactions with vendors and other internal and external stakeholders.
Scope of Authority
% of Time
Risk Assessment and Monitoring
§ Conduct compliance risk assessment, develop/update compliance monitoring plan based on the results of the risk assessment, including performing necessary updates to the monitoring procedures to adequately address compliance risks.
§ Execute monitoring of the compliance of promotional and non-promotional business activities, including conducting live monitoring and leading transactional reviews independently or with assistances from third party vendors.
§ Accurately and thoroughly document monitoring findings within monitoring templates and system. Summarize the findings and suggest recommendations to Compliance Officers. Follow up with Compliance Officers and other internal stakeholders on remediation activities and tracks remediation until completion.
§ Conduct transactional monitoring, including collaborating cross-functionally to identify and gather relevant supporting records, conducting records review to assess compliance with policies/procedures.
§ Manage the compliance monitoring system, documenting monitoring findings, tracking status of open issues until closure, and providing training to new team members, as appropriate.
Investigations and Ethics Hotline
§ Assist with or perform corporate investigations as part of a cross functional team adhering to the Company’s investigation procedure. Assist with conducting documentation reviews, preparing summary reports and documenting the results in the case management system.
§ Provide insight, analysis and reporting with respect to the nature of investigations over time for purposes of developing trends and whether additional training may be needed.
§ Manage Ethics Hotline by conducting initial assessment of hotline reports and triaging to the appropriate investigative team for further investigation. Provide guidance to other functions to help adhere to Company’s investigation procedure.
§ Analyze investigations trends and metrics, creating reports for use by Senior Management.
§ Manage and monitor the Investigations Case Management System and Ethics Hotline through strategic partnerships with BU Compliance Officers and relevant business departments; collaborate with vendor on ongoing system enhancements; support investigation activities.
§ Provide required documentation for internal and external audits of the Ethics & Compliance Hotline. Review and supply summary and detailed case information to support reporting to senior management or Board of Directors.
Data Analytics, Reporting and Collaboration
§ Collaborate with Compliance organization and relevant business stakeholders to identify areas of risk, monitoring opportunities and areas of improvement for Compliance and/or operational activities such as enhancements to policies/procedures, processes, training or technology.
§ Develop approaches for monitoring using data from various financial and business systems (e.g., CRM, SAP, Concur) and using data mining techniques to assist with monitoring.
§ Summarize monitoring results and findings, gather supporting information and prepare dashboards of key trends and findings from monitoring activities and investigations for communication to Business Unit Compliance Officers, Compliance Committee meetings and/or relevant management.
§ Provide investigation, monitoring data and trends for Global Compliance Committee, the Board of Directors reports, due diligence requests or requests from the Legal department.
§ Provide ad hoc support to other members of the Compliance department.
§ Serve as a subject matter expert on external regulations and internal processes, policies, and procedures relevant to our compliance risk areas.
§ Active, productive and collaborative member of Compliance Department who works well across functions, lines of business and geographies.
Education & Experience
§ BA required.
§ A minimum of 5-7 years of compliance, finance, accounting, legal or other business function experience required; preferably pharmaceutical/device/healthcare.
§ Working knowledge of various laws, regulations, and industry guidance that affect Endo’s compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, PDMA, OIG, FCPA and PhRMA guidelines, state and federal aggregate spend reporting laws and corporate integrity agreements.
§ Experience with use of analytical tools for data analysis.
§ Experience managing projects with the ability to manage multiple projects/assignments concurrently and demonstrated project management skills
§ Strong inter-personal and communication skills.
§ Ability to travel up to 20% of the time.