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successfactors

Senior Manager/Associate Director Compliance North America and the United Kingdom

Hikma Pharmaceuticals PLC
Berkeley Heights, USA
Full-time
Senior · 10–12 years experience
Onsite
Discovered 6 days ago
Communication

Full Job Posting

Responsibilities

  • Anti-Corruption & FCPA Compliance Support Hikma's anti-corruption compliance program in alignment with the U.S. Foreign Corrupt Practices Act (FCPA), the UK Bribery Act 2010 (as applicable to U.S. conduct with a UK nexus), and Group anti-bribery and anti-corruption (ABAC) policy. Support the management of third-party due diligence (distributors, agents, consultants, HCP/HCO interactions) and maintain risk-based monitoring of higher-risk relationships and transactions. Support oversight of gifts, meals, entertainment, and hospitality controls applicable to interactions with healthcare professionals, government officials, and regulators. Support or assist in the management of internal investigations into suspected corruption or bribery issues, coordinating with the relevant stakeholders. Healthcare Fraud, Abuse & False Claims Act Compliance Support the oversight of the U.S. healthcare compliance program consistent with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, covering the Federal Anti-Kickback Statute, the civil False Claims Act (FCA), the Physician Payments Sunshine Act (Open Payments), and related state marketing/reporting laws. Support Open Payments/Sunshine Act data capture, aggregate spend tracking, and state marketing compliance law reporting. Auditing, Monitoring & Transparency Reporting Support the execution of a risk-based compliance auditing and monitoring plan across HUSA's commercial, manufacturing, and R&D operations, including transaction testing, field-level monitoring (e.g., HCP interactions, expense reports), and periodic control effectiveness reviews. Track and report on remediation of findings from compliance audits, monitoring activities, and regulatory inspections, ensuring corrective and preventive actions are implemented and closed out on schedule. Support U.S. transparency reporting obligations, including Open Payments/Sunshine Act aggregate spend reporting, state marketing compliance law disclosures, and other mandated transparency filings, ensuring accuracy, timeliness, and audit-ready recordkeeping. Prepare U.S. compliance metrics, audit and monitoring results, and transparency reporting updates for the Group Chief Compliance Officer. Other Regulatory & Compliance Matters Support the development of risk-based compliance training and communications for U.S. employees, including onboarding and role-specific modules. Support management of U.S.-specific compliance policies and procedures, ensuring alignment with Group-wide compliance policy while reflecting U.S. legal requirements. Assist the Regional Head of Compliance in other Program areas as may be necessary.

Qualifications

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: J.D. or equivalent U.S. law degree preferred; alternatively, a bachelor's degree with substantial relevant compliance experience. Compliance certification (e.g., CCEP, CCEP-I, CHC) desirable. Minimum 10-12 years of progressive compliance, legal, or regulatory experience, with at least 5 years focused on healthcare/pharmaceutical compliance in a U.S.-regulated manufacturer, distributor, or life sciences company. Demonstrated working knowledge of the FCPA, the federal Anti-Kickback Statute, the civil False Claims Act, the Sunshine Act/Open Payments, and U.S. AML/sanctions frameworks (OFAC, BSA). Experience operating within a multinational, publicly listed group structure and reporting into non-U.S. corporate headquarters/Board governance (UK-listed company experience a plus). Experience managing government investigations, internal investigations, or corporate integrity agreements is highly desirable. Excellent written and verbal communication skills, with the ability to prepare Board- and Audit Committee-level materials. Ability to travel domestically (and periodically internationally as required. The role may require travel up to twenty-five percent (25%) of the time This is a hybrid role requiring four days in the office.

Preferred Qualifications

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: J.D. or equivalent U.S. law degree preferred; alternatively, a bachelor's degree with substantial relevant compliance experience. Compliance certification (e.g., CCEP, CCEP-I, CHC) desirable. Minimum 10-12 years of progressive compliance, legal, or regulatory experience, with at least 5 years focused on healthcare/pharmaceutical compliance in a U.S.-regulated manufacturer, distributor, or life sciences company. Demonstrated working knowledge of the FCPA, the federal Anti-Kickback Statute, the civil False Claims Act, the Sunshine Act/Open Payments, and U.S. AML/sanctions frameworks (OFAC, BSA). Experience operating within a multinational, publicly listed group structure and reporting into non-U.S. corporate headquarters/Board governance (UK-listed company experience a plus). Experience managing government investigations, internal investigations, or corporate integrity agreements is highly desirable. Excellent written and verbal communication skills, with the ability to prepare Board- and Audit Committee-level materials. Ability to travel domestically (and periodically internationally as required. The role may require travel up to twenty-five percent (25%) of the time This is a hybrid role requiring four days in the office.

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