Corporate Compliance, Change Management, Risk Management, Legal Services, Process Improvement, MBA, Lean DMAIC Six Sigma, Department Launcher/Startup Artist

• Highly qualified and motivated professional with comprehensive experience serving healthcare, biotech, commercial and consumer finance companies and higher education organizations, for profit and nonprofit, advise on matters of operating procedure and business practices in compliance with federal and state and some non U.S. laws, regulations and rules as well as industry and accreditation standards. Utilizes unique combination of business acumen, problem solving skills and legal/regulatory knowledge to promote change and achieve success in various environments e.g. startup, growth . Core competencies include:
• Change Management Problem Solving Project Management Process and Improvement Engineering Business and Legal Research High Tech Savvy Launching, Maintaining and Improving Corporate Compliance Programs Code of Conduct Development Policy and Procedures Writing and Developing Governance Policy and Procedures Development Risk Management Wide ranging understanding of Legal and Regulatory requirements Legal and Compliance Guidance Records Management Launching, Maintaining and Improving Privacy and Medical Records Programs Internal Auditing process development

WORK EXPERIENCE

Corporate Compliance and Privacy Officer

confidential

• Manage daily corporate compliance and privacy program including governance, risk and compliance activities. Oversees and ensures the right of the practice/organization's patients to inspect, amend and restrict access to protected health information. Developed and maintain oversight of center wide incident reporting system. Research, develop, implement and maintain policies and procedures, development process and management systems. Advisor to C suite leadership, department leaders and management and other representatives and/or partners. Identifies areas of risk, governance, and compliance vulnerability. Event reporting, Patient Privacy and Confidentiality, and process improvement trainer. Subject Matter Expertise: CADA incl. federal patient privacy/confidentiality law HIPAA MGL privacy law Gramm Leach Bliley PCI Security Standards HITECH Anti kickback False Tort Claims Act False Claims Act CLIA Risk Management. Billing and Medicare/Medicaid exposure. Accomplishments:
• Built the governance, risk, and compliance program from scratch.
• Established internal audit process including billing, contract administration, and clinical auditing. Established process improvement function.
• Established formal governance, risk, and compliance program including governance, risk, and compliance program plan.
• Authored core clinical including laboratory quality , operational, and ethics compliance policies and procedures.
• Established event reporting process.
• Established formal shadowing program between organization and elite medical school.
• Co worker coaching and mentoring.
• Established Governance, Risk, and Compliance Committee
• Established Quality Subcommittee IT/IS Subcommittee Operations Policy Subcommittee
• Advised in establishment of Clinical Subcommittee and Credentialing Subcommittee
• Advise on business model to maximize revenue
• Corporate Compliance and Privacy Officer

confidential

• Oversaw daily corporate compliance program including monitoring activities. Oversees and ensures the right of the practice/organization's patients to inspect, amend and restrict access to protected health information, when appropriate. Oversight of center wide incident reporting system. Research, develop, implement and maintain policies and procedures, development process and management systems. Advisor to senior leadership, department leaders and management and other representatives and/or partners on compliance strategy. Identifies areas of compliance vulnerability and risk. Event reporting and Patient Privacy and Confidentiality Trainer. Subject Matter: HIPAA Rhode Island General Law incl. confidentiality and privacy law Sliding Fee / Discount Program Gramm Leach Bliley PCI Security Standards HITECH Anti kickback False Tort Claims Act False Claims Act Family Educational Rights and Privacy Act FERPA Public Health Services Act Sec. 330 Drug Pricing Program Sec. 340B Risk Management. Projects: Downtime, ICD 10 upgrade/conversion, HRSA Audit, Intranet reorganization, process automation. Committee membership: Quality Improvement Committee. Accomplishments:
• Re engineered and improved event/incident reporting process and system online database tracking including reporting event reporting structure and root cause review process.
• Established and editor of monthly compliance newsletter Talking Points covering a variety of compliance topics to improve employee population understanding of legal/regulatory and policy requirements.
• Created compliance and risk tracking and assessment reporting process.

Senior Compliance Specialist

confidential

• Managed daily compliance operations for 11B medical device and pharmaceutical company est. 42,000 employees extending from the United States to twenty six 26 other countries. Oversaw global code of conduct updates including translation into twenty six 26 languages. Assisted Office of the Ombudsman on compliance initiatives. Developed and distributed global corporate compliance and ethics communications/ newsletter. Developed enterprise policies and procedures. Oversaw records management program US and non US territories including Internet based records management system. Advisor to Enterprise Records Management Committee. Enterprise compliance e learning system administrator for corporate compliance and ethics topics e.g. code of conduct, ethics, AdvaMed Code, conflicts of interest, etc. along with the creation of specialized content e.g. video and interactive . Managed corporate compliance enterprise Intranet sites. Liaise to Business Units, Vendors, Function Area representatives and/or Divisional Compliance SME. Projects: code of conduct translations 26 languages , policies and procedures translations, development of new corporate
• compliance and ethics training courses e.g. Guide to Business Conduct, Conflicts of Interest, Massachusetts Code, Vermont Code including translations and vendor selection. Process Engineering: designed, controlled, and optimized corporate compliance processes including supporting documentation e.g. standard work, operations guides, PowerPoint Presentations, etc. . Accomplishments:
• Re engineered and improved the records management program covering United States operations.
• Oversaw the cleanup and transfer of more than a million physical records from United States based locations to non United States location.

Corporate Compliance Manager

confidential

• Oversaw of ethics and compliance program including Helpline investigation. Oversaw of enterprise compliance information system and ethics compliance education and training system. Managed licensing operations for commercial and consumer lending operations. Managed compliance personnel work assignments, daily decision making e.g. recruitment input, training, and assignment of projects and goal setting, and performance evaluations for direct reports. Implemented and maintained company wide reporting system to facilitate disclosure of violations of code of conduct, law and/or policy and procedure. Lead on annual compliance risk management initiatives. Subject Matter Expertise: Federal OFAC, US Patriot Act, Bank Secrecy, etc. and State Law 50 state lending, collection, and insurance laws . Member of Textron Inc. Ethics Compliance Working Group. Advisor to Steering Committee. Accomplishments:
• Successfully lead organization through more than twenty 20 annual external regulatory license examinations and audits for licenses covering residential and commercial lending activities, insurance and debt collections.
• Effectively maintained several hundred lending, insurance and collection agency licenses issued by regulatory bodies across throughout the United States and other countries and foreign regions.
• Maintained licensing and corporate governance processes for more fifty 50 independent corporate entities.
• Formalized enterprise policy Know Your Customer KYC , Customer Identification Program CIP to ensure systems and processes meet regulatory requirements.
• Developed, implemented and managed annual enterprise risk assessment and the organization action plan to address enterprise risks.
• Successfully organized and planned quarterly Steering Committee meetings and reporting from various business units domestic and international.
• Redesigned several enterprise Compliance processes.
• Special Project Assistant/Coordinator, Brown University Providence, RI 2001 to 2003
• Regulatory and Compliance Consultant, Self Employed Beverly, MA 1999 to 2001
• Senior Compliance Paralegal, Insurance Holdings of America, Inc. Beverly, MA 1998 to 2000 Other positions held: Compliance Paralegal
• Senior Financial Assistant Liberty Mutual Insurance Group Dover, NH 1995 to 1998 Other positions held: Financial Assistant I Financial Assistant II