San Rafael, CA
Less than 5 years
Posted 292 days ago
The purpose of the Manager/Senior Manager, Compliance Counsel, Global Compliance & Ethics position is to assist the Associate Director, Global Compliance & Ethics in analyzing and addressing risk by developing, implementing, updating, monitoring, and enforcing the compliance policies, initiatives, and processes of BioMarin Pharmaceutical Inc. and its subsidiaries’ (collectively referred to as “BioMarin”) as part of the Global Compliance Program (“GCP”).
• Develop expertise in the legal and compliance risk areas facing rare-disease biopharmaceutical companies (e.g., advertising & promotion, fraud & abuse, anti-kickback, privacy, GXP, and false claims act statutes)
• Support the development, implementation, and maintenance of GCP activities, including counseling and training on compliance policies, anti-bribery/anti-corruption laws, healthcare compliance regulations, privacy, and transparency/aggregate spend regulatory requirements.
• Develop and manage global monitoring project, including risk evaluation and assessment and development of monitoring plans and initiatives to categorize, review, and address risk.
• Develop understanding in enterprise systems to develop and refine data monitoring program to identify and remediate compliance risks.
• Refine and implement training systems enhancements and creation of training plan and modules in connection with compliance policies. Present trainings to business units as needed.
• Work with internal functional areas to provide advice and counsel, ensure appropriate/adequate training, and support adherence to policies/procedures relating to compliance matters.
• Draft memoranda providing legal analysis and risk-based recommendations regarding the compliance rules and regulations (e.g., advertising & promotion, fraud & abuse, anti-kickback, privacy, and false claims act statutes) implicated by proposed or existing business strategies.
• Counsel internal brand teams regarding the aforementioned compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations.
• Develop familiarity with broader organization to identify, analyze, and mitigate risk.
• Assist with investigation of alleged violations of compliance policies, laws, regulations, or procedures.
• Develop and implement corrective action plans where compliance violations have been established.
• Assist with the review and analysis of advertising and promotional initiatives, pipeline products/clinical trialrecruitment materials, grants/donations and sponsorships, government price reporting and related research on FDA/OIG enforcement activities.
• Prepare monthly briefing documents to keep Executive Management up-to-date on latest industry events and trends including OIG and FDA enforcement statistics, CIA trends, global enforcement trends, and analysis of OPRP/DDMAC warning and untitled letters.
• Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
• Coordinate project management of various GCP related activities and requirements, including management and coordination of outside consultants.
A Bachelor’s degree and JD are required.
• 2 - 4 years of experience practicing law or working in the pharmaceutical/healthcare compliance field. Experience in-house, at a regulatory agency, or at a major law firm strongly preferred.
• Experience with, or eagerness to become expert in, compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally.
• Experience with, or eagerness to develop knowledge and understanding of, the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
• Experience with, or eagerness to develop 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, FDA regulations on the promotion of marketed products, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
• 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, drive projects, and allocate resources.