Senior Manager, ComplianceLocation 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.
The Senior Manager, will have primary responsibility for overseeing the compliance monitoring and training programs to address the risk areas facing rare-disease biopharmaceutical companies (e.g., advertising & promotion, fraud & abuse, anti-kickback, privacy, GXP, and false claims act statutes).
- Oversight of the monitoring program will involve conducting risk evaluations and assessment, development of monitoring plans and initiatives, and implementation and refinement of systems and processes to manage and report monitoring activities.
- Live monitoring of activities, including speaker programs, advisory boards, symposia, conference activities, field engagements, and phone and online-based activities.
- Developing familiarity with BioMarin’s enterprise systems to develop and refine data monitoring program to identify and remediate compliance risks.
Management of the compliance training program will involve implementing training systems enhancements and creation of training plans and modules in connection with compliance policies.
- Presentation of trainings to functions across the business.
- Development of innovative training programs and techniques to maximize engagement and retention
Work with internal functional areas to ensure appropriate/adequate training, and support adherence to policies/procedures relating to compliance matters.
- Draft, update, and revise policies and guidelines as necessary and in response to findings form monitoring and training efforts.
- 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.
- 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 required. JD is preferred.
- 4 - 8 years of experience working in the pharmaceutical/healthcare compliance field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
- Experience with compliance monitoring or training within the pharmaceutical, biotechnology, and/or healthcare industry generally.
- Experience with the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
- Experience with the compliance 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.
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.