Location: Berkeley Heights, NJ
Job Type: Full-Time
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Senior Manager or Associate Director, Compliance Americas & UK to join our team. This role will be a member of the global compliance team responsible for the implementation, and day-to-day operation of North America & UK compliance programs for Hikma Pharmaceuticals PLC.
This role helps to support Compliance Fraud waste and abuse Compliance and regulatory requirements for the corporate organization. This role will provide specific support for ensuring that commercial, manufacturing, R&D, and quality operations comply with all applicable U.S. federal and state healthcare, anti-corruption and anti-fraud as well as Group-wide compliance policies and the UK Bribery Act, Corporate Governance Code expectations that flow down from the Hikma Board.
The role will also perform various operational activities in support of the Americas & UK Compliance Programs. This role will be responsible for implementing certain strategic initiatives to ensure that Compliance Risks are appropriately identified, managed, and remediated; implementing and overseeing Departmental data analytics processes, and project management requirements as follows:
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…