Executive Director Compliance & Regulatory

The Executive Director Compliance and Regulatory is responsible leading the quality and compliance efforts for multiple client projects and ensuring all local and federal regulations are followed.  This position will be responsible for contributing to and managing a team of Eversana internal employees and external vendor in the design, development, and delivery of complex projects covering a variety of subject matter areas.Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:Strong understanding of healthcare compliance and enforcement environmentFalse Claims Act, Anti-kickback Statute, anti-bribery considerations, and CDE rules and regulationsFood Drug and Cosmetic Act U.S.C. Title 21, Chapter 9Affordable Care ActFalse Claim Act 31 U.S.C. 3729-33Anti-Kickback Statute Social Security Act SEC. 1128B. [42 U.S.C. 1320a-7b]PhRMA CodePrescription Drug Marketing ActHHS-OIG GuidelinesHIPAAOther State LawsGeneral Data Protection Regulations (GDRP)Commercial compliance consulting: risk assessments, policies and SOPs, training materialsTransparency reporting and aggregate spend: process assessments, policies and SOPs, business process outsourcing and managed servicesKnowledge of commercial compliance and ability to conduct training as it relates to the   Life Sciences industries and how they effectively and compliantly interact with HCPs/HCOs and operate in the marketplaceSupporting development of proposalsAuditing and Monitoring: plan development, live monitoring, transactional reviews, data analytics and outsourced managed monitoring servicesWorking knowledge of global (EU) data laws at the country specific levelData Management and Data Protection:  must be the lead advocate in managing the compliance and operations oversight to handling  Third Party or Client Data following the Security and Privacy policies within Deployment Solutions. [lets discuss…confirm ie: PI?]Program and process design: compliance programs, HCP engagements, FMV, grants and contributions management (Honorarium, Sunshine Act)[these are diff activity…sunshine act not app; honorarium is a process]Sales activities (expense report sign in sheets etc):  Accuracy of Data and Records and QA auditing Sales ForceDrug Samples distributed to prescribers (FDA)Any transfers of value provided to U.S. licensed physicians and teaching hospitals, including Clinical Research Spend (CMS’ Open Payments Program)Specific State regs on Aggregate Spend reportingVendor CredentialingInternal projects and initiatives as needed specific for Deployment SolutionsOversight of the creation of content of templates and training materials to streamline and optimize new project start-up and team-member onboardingManaging and collaborating with project teams in the design, development, and delivery of client deliverablesProviding guidance on oversight, tracking, and monitoring of project status and delivery specific to Deployment Solutions Compliance activitiesProviding high level input to, and ensures the development of, client reports and presentations and delivery of all or significant portions of findings to client[can we discuss]Leveraging Life Sciences experience and business acumen to recommend improvements and alternative solutions to resolve client challenges Partner with Deployment Solutions to ensure client deligh.Sharing subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients[discussadvisory level not SME?]Adverse Events and Product Complaints fully understood and the advocate for Deployment SolutionsOn the Road or Virtual Field auditing the Sales RepsInternal Auditing and Monitoring program and  internal review of Business activity related to COC and the Compliance Program. Random and For Cause elements.Established and manage Corrective Actions and Disciplinary actions program from inception to completionIn addition to the client-focused activities, you are expected to contribute to the continued growth of the practice including:Working closely with Corporate Quality & Compliance and other BU leadership to align with Policy, Practices, and Compliance Escalations and provide “Quality at the Source” oversight to ensure Compliance to Regs and Laws. Institute a Quality Management System and Compliance program within Deployment Solutions Operations, including 1- Developing robust SOPs, Work Instructions and Job Aids, so all Job Roles are accountable for their responsibilities within each area of Deployment Services Operations 2- Compliance oversight to Training to operations Policy and Procedures 3- Operations support of Client and Internal Audits  4-Operational support to Non Conformance and CAPAs 5-Operational Continuous Improvements determined by MBR and QBRAll other duties as assigned.