Mary Beth Delgado Email & Phone Number

United States

Greater Philadelphia Area

Member of senior leadership team reporting to the Chief Legal Officer for a gene therapy company. Lead Corporate Compliance function to build and develop Compliance, Internal Audit and Enterprise Risk Management programs.

Greater Philadelphia Area

Greater Philadelphia Area

Sought out by executive leaders and business partners to provide interim compliance consulting support including, strategic advice, policy development, monitoring and auditing services and general oversight of healthcare compliance programs.

Malvern Pa

Endo Pharmaceuticals acquired Auxilium Pharmaceuticals in January 2015.Integrate legacy Auxilium systems, policies, and procedures to ensure compliance with Endo Pharmaceuticals’ Corporate Integrity and Deferred Prosecution Agreements. Recommend and implement modifications to Auxilium’s Compliance Program as a result of an assessment conducted by an Independent Review Organization. Successfully execute the Integration Plan in collaboration with the Corporate Compliance team and business units for extensive operations and activities in Corporate Compliance, Commercial, Medical Affairs and Research and Development.

Malvern, Pa

Served as deputy to the Chief Compliance Officer to build, implement, and maintain Auxilium’s first comprehensive Compliance Program, including designing, reviewing, and implementing internal controls, policies, and procedures to ensure compliance with FDA regulations, HHS OIG “7 Elements” guidelines, fraud and abuse standards, applicable federal and state laws, regulations and industry guidelines.• Collaborated as compliance partner for all corporate business functions. Supported business partners as the compliance subject matter expert and provided compliance counsel to Legal, Sales and Marketing, Clinical Development, Medical Affairs, Human Resources and Finance.• Conducted compliance risk analyses, identified risk trends and potential areas of vulnerability, and recommended remediation and mitigation activities to the Healthcare Compliance Committee and Board of Directors. Developed corrective action plans; implemented new policies and/or revisions to existing policies, procedures, and training; and monitored risk management activities Initiated, managed, and conducted US Healthcare compliance monitoring and auditing activities. • Served as Secretary on the Healthcare Compliance Committee.• Evaluated and recommended initiation of investigative procedures and corrective actions regarding alleged violations of internal policies and procedures and/or the Auxilium Code of Conduct. • Chaired the Legal and Compliance collaboration meetings between the Compliance team, Commercial counsel, and Research and Development counsel. Discussed interdepartmental issues and challenges, negotiated options for resolution.• Actively participated in acquisitions. Developed and conducted compliance-related remediation activities for acquisition of a privately-held company. Prepared responses to inquiries from Endo Pharmaceuticals during the Due Diligence process; served as Auxilium’s Corporate Compliance integration lead throughout all acquisition activities.

Chesterbrook, Pa

Advised on the development and implementation of policies, procedures, and training activities to identify and effectively resolve compliance gaps for the company’s impending Corporate Integrity Agreement with the US Office of the Inspector General. Conducted assessments in collaboration with the Health Care Compliance team and determined potential areas of risk, including the following business operations and activities:• Engagements with healthcare professionals (HCPs) for medical science liaison activities, publications, clinical trials, continuing medical education, and investigator-sponsored research. • Hiring HCPs as consultants and recommending specific controls for the hiring, contracting, and payment processes; developing fair market value methodology for setting an appropriate payment structure for HCP consultants; conducting qualifying assessments of HCP consultants’ credentials, professional qualifications, and exclusions. • Process audits and internal monitoring activities for non-promotional activities. • Auditing consultant contracts to ensure alignment with applicable laws, industry codes, guidelines, and company policies.• Establishing governance for scientific advisory boards.

Directed the strategy and operations of the global Pfizer Legal Alliance (PLA). Established unique, complex, groundbreaking model for Fortune 100 companies working with multiple law firms and vendors. • Directed all business operations, including strategic development, budgeting and planning, and liaison process and management with legal leadership (department of 1,000 staff), law firms, vendors, business units, and Pfizer executive management team. Managed a budget of $450M and 19 law firm relationships. • Led development and implementation of processes; established assignment and monitoring of legal division work to ensure effective program participation; developed law firm flat fees and budgets; and created reporting protocol for tracking new work assignments against initial flat-fee components.• Liaised between Pfizer business units and attorneys to effectively match in-house counsel needs and legal matters with appropriate law firm expertise Led proposal process for PLA law firms and vendors; negotiated and managed PLA Agreements; and managed relationship between in-house counsels and PLA firms.

Executive Director, Law Department (2006 – 2009)Senior Director, Law Department (2002 – 2005)Led Practice Group of 20 attorneys and legal professionals. Provided advice and counsel to the global clinical research and medical affairs organizations. Reported to Sr. Vice President/Associate General Counsel. • Led development of a company-wide global compliance training program and implementation strategy focused on documentation and business communication for 50,000 employees.• Managed global compliance audits and investigations for clinical research related to government investigations and subpoenas.• Established extensive range of policies and procedures to ensure compliance with FDA regulations, HIPAA, FCPA, fraud and abuse standards, applicable federal and state laws, regulations and industry guidelines.• Led the cross-functional team responsible for harmonization of standard operating procedures across the global research organization.• Provided compliance guidance related to clinical research activities. Established policies and procedures for the Research and Development organization related to fair market value payments to HCPs and tracking and reporting of such payments to Wyeth senior management.• Analyzed legal/compliance matters related to clinical research; assessed legal, compliance, and financial risks; and presented solutions to senior management.• Drafted, negotiated, and managed contracts related to clinical research activities.

Represented Wyeth Law Department on commercial brand teams. Participated in advisory boards, lifecycle management and strategy meetings, pricing and rebate meetings, sales call “ride-alongs,” and National Account and Managed Care commercial activities.• Conducted legal research and directed process for managing multiple litigations and government investigations for Wyeth Law Department.• Drafted and negotiated clinical research and commercial agreements.• Hired, trained, and managed paralegal team responsible for litigation.

Ba, English/Business Minor

Ms, Health Administration