Global Compliance Counsel, Anti-Bribery& Anti-Corruption ProgramsLocation San Rafael, California Apply
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
Director, Compliance Counsel, Anti-Bribery Anti-Corruption Program and Investigations
Global Compliance & Ethics
The purpose of the Director, Compliance Counsel, Global Compliance & Ethics position is to assist the Vice President, Deputy Compliance Officer in implementing, updating, monitoring, and enforcing the compliance policies and processes of BioMarin Pharmaceutical Inc. and its subsidiaries’ (collectively referred to as “BioMarin”) as part of the Global Compliance & Ethics Program (“GCEP”). Specifically, the Director will support the Anti-Bribery Anti-Corruption (“ABAC”) Program and Investigations.
Support the development, implementation, and maintenance of GCEP activities relating to the ABAC Program, including counseling and training on compliance policies, development of ABAC procedures, management of investigations, and support of cross-regional GCE partners to ensure business activities comport with global healthcare compliance regulations.
Develop and execute on global ABAC program development, including:
- FMV Program – Support workable, business-oriented solutions for achieving fair market value in payments to HCPs and patient/PAG stakeholders worldwide.
- Due Diligence – Refine process for vetting partners and consultants, leveraging external background check resources as well as internal systems, and ensure systematic escalation and vetting of “red flags.”
- Monitoring and Healthcare Audits – Ensure that appropriate ABAC data monitoring, healthcare audits and assessments, and response protocols are in place to respond to developing risks.
- Training – partner with training program owners to ensure global and regionally tailored training is implemented, recorded, and updated as necessary.
- Enforcement – partner with GCE regional personnel to ensure appropriate discipline and consequences for ABAC policy violations based on “Global Progressive Discipline” policy. Create corrective action plans to ensure that business units implicated prevent future non-compliance.
- Messaging – ensure deterrence through company-wide messaging and information regarding ABAC risks and consequences for violative conduct (e.g., use regional communications or other training opportunities to discuss GCE’s risk mitigation efforts).
- Dawn Raid Policy/Process and Training – partner with training program owner to ensure regional GCE and business personnel are briefed, trained, and prepared for dawn raid scenarios.
Manage the Global Monitoring Program:
- Develop North America’s regional heat map and monitoring plan, and establish uniform approach to global development of risk assessments and monitoring plans.
- Support regional GCE personnel in establishing regional monitoring/audit plans.
Manage cross-regional coordination and communication:
- Provide centralized GCE support to business stakeholders undertaking global (cross-regional) activities, and support analysis of regional GCE activities and controls to ensure GCE takes a consistent global approach to compliance controls where workable, and that any regional inconsistencies are considered and appropriate.
- Manage investigations of alleged violations of compliance policies, laws, regulations, or procedures as needed on a global basis.
- Develop and implement corrective action plans where compliance violations have been established.
General Global Compliance and Ethics Support:
- Assist with creation of a global training plan and training modules in connection with the ABAC Program. Present trainings to global business units and partners as needed.
- Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
- Coordinate project management of various GCEP related activities and requirements, including management and coordination of outside consultants.
A Bachelor’s degree and JD are required.
- 6 - 8 years of experience practicing law handling FCPA and/or ABAC matters or programs, including management of investigations. In-house experience at a pharmaceutical/biotechnology organization or regulatory agency strongly preferred. Major Law firm experience a plus.
- Experience with and/or understanding of compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally.
- Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
- Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, and in particular issues arising under the FCPA, Anti-Kickback Statute, or other ABAC laws.
- Demonstrated effectiveness operating in complex organizational and regulatory environments.
- Excellent written, oral, and presentation skills.
- Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
- Strong problem solving, risk analysis, and project management skills.
- Demonstrated ability to partner effectively with others in addressing complex issues.
- Strong persuasive skills and sound business judgment.
- Motivated, self-starter with ability to appropriately prioritize issues and allocate resources.
WORK ENVIRONMENT / PHYSICAL DEMANDS:
Must be willing to travel, including internationally, as necessary. One international trip per quarter required.
Laptop and cell phone.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.