Ernie Hernandez Email and Phone Number
Experienced Chief Compliance Officer with a demonstrated history of successfully managing, developing and implementing essential elements of effective Compliance Programs in support of multiple product launches in the biotech and pharmaceutical industries. Strong personnel and program management skills in the Healthcare Compliance areas of policy, training, auditing, monitoring, investigations, and risk assessment and risk mitigation activities in regards to laws, regulations, and industry standards that govern interactions with healthcare professionals, healthcare institutions and organizations, and patients.
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Senior Compliance ConsultantBiopharma CompaniesCalifornia, United States
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Vice President And Chief Compliance OfficerGlobal Blood Therapeutics May 2019 - PresentSouth San Francisco, California, UsStrategic responsibility for the global management, development, and implementation of GBT’s Healthcare Compliance Program in regards to its U.S. and international interactions with healthcare professionals (HCPs) and Healthcare Organizations (HCOs) in alignment with applicable laws, regulations, industry standards, and local ordinances. Global development and implementation of GBT’s Healthcare Compliance Program in support of the global launch and commercialization of the product Oxbryta consisted of such initiatives as developing and implementing policy, training, communication, monitoring, and transparency initiatives in an effort to remain compliant with applicable laws and industry standards such as the Federal Anti-Kickback Statute, Food, Drug & Cosmetic Act, PhRMA Code, OIG Compliance Program Guidance, Federal "Sunshine" Act, Foreign Corrupt Practices Act, and United Kingdom Anti-Bribery Act. -
Senior Director, Healthcare Compliance OfficerAdamas Pharmaceuticals, Inc. Jul 2017 - May 2019Emeryville, California, UsStrategic responsibility for the management, development, and implementation of the Adamas Healthcare Compliance Program as part of a fast-paced pharmaceutical product launch environment in support of the commercialization of the neurology product, Gocovri. Management of the Adamas Healthcare Compliance Program consists of such activities as developing and implementing the seven elements of an effective Compliance Program as prescribed by the OIG: policy, training, communication, monitoring, auditing, and investigation initiatives as well as executing on the Adamas annual federal and state transparency reporting obligations. -
Senior Director, Healthcare ComplianceZs Pharma, Inc. Apr 2016 - Jul 2017San Mateo , California , UsAs part of a fast-paced pharmaceutical product launch environment, held the primary responsibility of managing the development and implementation of ZS Pharma’s Healthcare Compliance Program in support of the commercialization of the Renal product, Lokelma.ZS Pharma’s Healthcare Compliance Program consists of such activities as developing and implementing policy, training, communication, monitoring, and transparency initiatives in an effort to remain compliant with applicable laws and industry standards such as the Federal Anti-Kickback Statute, Food, Drug & Cosmetic Act, PhRMA Code, OIG Compliance Program Guidance, Federal "Sunshine" Act, and the European Federation of Pharmaceutical Industries and Association (EFPIA) Disclosure Code. -
Director, Compliance & EthicsMckesson U.S. Pharmaceutical Dec 2013 - Jan 2016Irving, Texas, UsManage Fraud & Abuse Compliance Program for McKesson’s U.S. Pharmaceutical (U.S. Pharma) Business Unit responsible for over $90 billion in revenue. The Fraud & Abuse Compliance Program consists of risk identification and risk mitigation activities including policy, training, communication, monitoring, and investigation initiatives regarding interactions with U.S. Pharma healthcare professional customers in an effort to remain compliant with applicable laws and regulations such as the Federal Anti-Kickback Statute. -
Senior Manager, Corporate ComplianceAllergan Aug 2012 - Dec 2013Dublin, Coolock, IeManage Compliance Monitoring Group's (CMG) day to day healthcare compliance monitoring activities for team of monitors as part of Allergan’s Corporate Integrity Agreement (CIA) Field Force Monitoring Program (FFMP) and Non-Promotional Monitoring Program (NPMP) . These monitoring programs provide potential compliance trends to management related to the appropriateness of interactions with healthcare professionals by proactively identifying potential observations and support continuous improvements regarding Allergan’s compliance reporting and certification requirements. -
Associate Director, Corporate ComplianceAmylin Pharmaceuticals Sep 2010 - Aug 2012San Diego, Ca, UsManagement of Amylin's Compliance Monitoring Program:- Sales Representative Ride-Alongs- Speaker Programs- HCP Spend- Advisory Boards- Product Samples- Promotional MaterialsManagement of Amylin’s Federal & State Marketing Law Reporting Requirements:- Federal Sunshine Act (System, Process, and Reporting Implementation)- Federal Product Sample Distribution Information Disclosures- State Marketing Laws (Minnesota, Massachusetts, Washington DC, Vermont) DisclosuresConduct Amylin Compliance Investigations -
Senior Manager, Genentech'S Healthcare Compliance OfficeGenentech Sep 2006 - Sep 2010South San Francisco, California, UsManagement of Genentech's Compliance Policy, Training, and Communication Initiatives:- Development & Implementation of Compliance Policies- Development & Implementation of Compliance Training Initiatives- Development & Implementation of Compliance Communication Initiatives- Responding to Compliance InquiriesManagement of Genentech’s Federal & State Marketing Law Reporting Requirements:- Federal Sunshine Act (System, Process, and Reporting Implementation)- State Marketing Laws (Minnesota, Massachusetts, Washington DC, Vermont) DisclosuresConduct Genentech Compliance Investigations -
Project Manager, Health Care ComplianceJohnson & Johnson - Scios Inc Jan 2005 - Sep 2006New Brunswick, Nj, UsManagement of Scios Compliance Policy and Training Initiatives:- Implementation of Compliance Policies- Implementation of Compliance Training Initiatives- Development & Implementation of Learning Management System (LMS)- Responding to Compliance InquiriesConduct Scios Compliance Monitoring Activities:- Medical Education Grants- Investigator Initiated Study/Trial Grants- Medical Conference Exhibit Booths- Investigator MeetingsManagement of Scios Aggregate Spend System Initiatives- Development & Implementation of Aggregate Spend SystemConduct Scios Compliance Investigations
Ernie Hernandez Education Details
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Saint Mary'S College Of CaliforniaBusiness Administration -
San José State UniversityNursing
Frequently Asked Questions about Ernie Hernandez
What company does Ernie Hernandez work for?
Ernie Hernandez works for Biopharma Companies
What is Ernie Hernandez's role at the current company?
Ernie Hernandez's current role is Senior Compliance Consultant.
What schools did Ernie Hernandez attend?
Ernie Hernandez attended Saint Mary's College Of California, San José State University.
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