Compliance & Ethics Professional

Barbara A. Buerkle, CCEP

***************@*****.*** www.linkedin.com/in/barbarabuerkle 973-***-****

PROFESSIONAL SUMMARY

Accomplished, solutions-oriented Compliance and Ethics Professional with over 20 years’ experience in the Pharmaceutical, Medical Device and TeleHealth industries. Proven success building and executing comprehensive corporate compliance programs, policies and training that foster an ethical culture, mitigate risk and ensure compliance with legal and regulatory requirements. Proficient at implementing and enhancing processes to optimize workflow efficiencies, strengthen internal controls, monitor compliance and improve data integrity and reporting. Resourceful team player, able to partner with management to provide continuous risk assessment. Energetic compliance champion, expert at building trusted relationships and collaborating with business stakeholders to support organization strategic and operational goals. Valued for my responsiveness, expertise and professional, customer focused approach. Expertise includes:

Program Management and Process Improvement

Risk Assessments, Third Party Compliance

Training, Communications, Policy Development

Application of Anti-Corruption, FCA, FCPA, HIPAA Laws

Data Analytics, Monitoring, Regulatory Reporting

Sunshine Laws and Aggregate Spend Reporting

PROFESSIONAL EXPERIENCE

Panasonic Corporation of North America (PNA) 2012 – 2017

Compliance Manager, PNA Compliance & Ethics Program (2016 – 2017)

Concurrent with HealthCare Compliance Manager Responsibilities (through April 2017)

Responsible for executing and administering key elements of PNA’s Compliance and Ethics Program including policy development, governance, training and communications, monitoring, reporting and enforcement.

Coordinated the annual global compliance awareness survey for 10K employees and conducted periodic focus groups to identify and assess compliance risks and ethical concerns and recommend risk mitigations.

Coordinated documentation and preparation of World’s Most Ethical Companies® application submission.

Developed streamlined policies to address risk areas, including anti-corruption and conflicts of interest.

Tracked regulatory changes and advised stakeholders on anti-bribery, anti-trust and data privacy risks and requirements to ensure compliance with laws and internal policies while optimizing performance.

Enhanced e-learning content, training communications and techniques to improve engagement for 7,500 employees. Increased monitoring, messaging and metrics reporting resulting in 85% training compliance.

Promoted ethical conduct and strengthened employee awareness and commitment to compliance by executing engaging initiatives including Compliance Stations, a compliance website, YouTube Values Video campaign, a compliance scavenger hunt and trivia contest, and compliance recognition awards.

HealthCare Compliance Manager, PNA Legal Department (2012 – 2016)

Responsible for building and managing a comprehensive HealthCare Compliance Program for Panasonic’s US medical device business in accordance with HHS OIG guidelines, legal and regulatory requirements, and industry standards. Responsible for providing regulatory and compliance guidance, education and support for Panasonic’s telehealth solution business initiative to ensure compliance with FDA regulations and mitigate HIPAA risk.

Coordinated risk assessment of Panasonic’s healthcare business to assess regulatory obligations under the federal Physician’s Payments Sunshine Act and state disclosure laws. Implemented processes to automate employee certifications and review business activity to ensure data integrity and timely reporting of Aggregate Spend certifications to federal and state government agencies.

Trained over 350 employees on the HealthCare Compliance Program, relevant healthcare laws, regulations and compliance risks, and regulatory reporting obligations including anti-kickback statute, FCPA, false claims act, privacy, sunshine law aggregate spend reporting, and industry standards (PhRMA, AdvaMed).

Proactively monitored the regulatory landscape and provided guidance to PNA’s Health & Wellness Solutions group on FDA 510K registration, HIPAA privacy and security, and telehealth regulations impacting the development, testing and marketing of Panasonic’s telehealth patient monitoring solution.

Conducted HIPAA risk assessments for PNA’s TeleHealth solution business in accordance with NIST and OCR HIPAA guidelines. Recommended and monitored execution of risk mitigation action plans.

Collaborated with business partners to develop and implement policies, internal controls and monitoring processes and provided training, education and guidance to ensure compliance with HIPAA regulations.

Barbara A. Buerkle, CCEP Page 2 of 2

Johnson & Johnson 2002 – 2011

Senior Analyst, Healthcare Compliance, J&J Pharmaceutical Sector COE (2008 – 2011)

Responsible for technology and process optimization, vendor management, training and operations support of J&J’s “Totality” system to facilitate efficient compliance workflow and complete, accurate documentation and data compilation for Pharmaceutical Sector Aggregate Spend reporting and other regulatory requirements.

Resolved process deficiencies by identifying root cause and implementing technology (Totality) and process enhancements to improve user effectiveness and data accuracy for regulatory reporting.

Awarded for driving successful closure of 1,250 historical healthcare projects in compliance with documentation and certification requirements. Provided guidance, education and expert technical support to internal and external business partners to ensure timely, accurate resolution.

Mitigated regulatory reporting risk by revamping and automating Aggregate Spend data submission templates, improving validation processes, and creating technical instructions to reduce user errors.

Improved data integrity for Aggregate Spend reporting by implementing processes to monitor, identify and resolve 3rd party data errors resulting in correction of 4,700 duplicate records in 119 projects, creating an inventory of practical technical resources, and launching a Supplier Resource website.

Mitigated Third Party risk by redesigning Supplier training for the external compliance application, delivering training to 600 users annually, and creating an e-learning module for new user on demand access.

Senior Analyst, HealthCare Compliance, J&J Global Strategic Marketing Company (2006 – 2007)

Supported healthcare compliance and privacy program initiatives for J&J’s global strategic marketing business. Developed policies, processes and controls, reviewed and monitored business activities and provided compliance guidance and support to stakeholders, conducted training, and designed compliance resources and website.

Earned a “Global Strategic Marketing Award for Excellence” for the seamless execution of compliance operations during a 67% reduction in staff, providing high quality support without interruption to business.

Received a “Standard of Leadership Award” for the successful implementation of an automated compliance project management system by executing impactful communications, training, and technical support.

Achieved a 100% completion rate on annual healthcare compliance training and EU Safe Harbor Privacy certification for a 250 person affiliate through effective communication, monitoring and diligent follow up.

Developed policies, conducted employee and vendor training, and provided tactical guidance to ensure organization compliance with US Anti-Kickback, False Claims, FCPA, Sunshine Act and HIPPA regulations.

Collaborated with legal, regulatory, and global compliance leads to evaluate and address US and regional compliance issues on over 125 annual global marketing activities with healthcare professionals.

Senior Financial Analyst, Finance, J&J Global Strategic Marketing Company (2002 – 2005)

Planned, designed, implemented and tested system accounting and reporting structures to successfully convert to SAP platform. Implemented SOX financial controls to drive process efficiency and data accuracy.

PRIOR PROFESSIONAL EXPERIENCE

Kelly Financial Services (Consulting) - Project Manager, J&J Sales & Marketing Finance

Streamlined the forecasting process and provided finance support for a $76M budget for the cross-sector, multi-phased capital project to implement a CRM technology solution for the Pharmaceutical sales force.

Prudential Financial – Associate Manager, Finance

Extensive accounting, financial reporting and budgeting experience in positions of progressive responsibility. Prepared and analyzed statutory, GAAP, and SEC financial statements, management reports and regulatory submissions. Developed and managed a $7M corporate shared service division budget.

EDUCATION & PROFESSIONAL CERTIFICATIONS

Bachelor of Arts, Economics and Accounting, Rutgers University, New Brunswick NJ

Certified Compliance & Ethics Professional (CCEP), Society of Corporate Compliance & Ethics (SCCE) (2016)

HealthCare Compliance Certification, Seton Hall Law School (2006)

Designing Learning Certification, American Society for Training and Development (ASTD) (2009)

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