Manager, Corporate Compliance
BioMarin Pharmaceutical Inc. · San Rafael, CA · 2 wk ago
On-siteLegalFull-time
About the role
The Manager, Corporate Compliance serves as a strategic compliance business partner to BioMarin’s US Commercial and Medical organizations. This role is responsible for providing practical, risk-based guidance on business activities, ensuring alignment with applicable healthcare laws, regulations, and internal policies.
Responsibilities
- Serve as a compliance advisor to Commercial and Medical teams, providing clear, actionable guidance on business activities, engagements, and strategies
- Interpret and apply healthcare laws, regulations, and industry codes (e.g., FDA, OIG, PhRMA) in a practical, business-relevant manner
- Provide risk-based recommendations on proposed initiatives, including field activities, patient programs, advisory boards, and HCP engagements
- Draft clear and concise legal/compliance analyses and guidance memoranda tailored to business stakeholders
- Proactively identify compliance risks and partner with stakeholders to develop pragmatic mitigation strategies
Training, Education & Enablement
- Partner with internal stakeholders to design and deliver targeted compliance training aligned to evolving business needs and risk areas
- Translate complex regulations into simple, actionable guidance to drive understanding and adoption
- Reinforce compliance expectations through ongoing education, coaching, and real-time guidance
- Support development and maintenance of policies, procedures, and tools that enable compliant decision-making in the field
Monitoring & Oversight of Business Activities
- Support and participate in monitoring of field and business activities, including patient events, advisory boards, speaker programs, and hub interactions
- Conduct live and/or retrospective monitoring to assess adherence to compliance guardrails and identify trends or gaps
- Partner with Commercial, Medical, and Compliance leadership to ensure appropriate follow-up, training, and remediation based on monitoring outcomes
- Support execution and continuous improvement of the Corporate Compliance monitoring program, including dashboard tracking and reporting
- Drive data-driven compliance monitoring by harnessing enterprise data and AI capabilities to generate actionable insights, detect emerging risks, and enhance the effectiveness of the monitoring program
Compliance Program Support
- Support the ongoing development, implementation, and maintenance of the US Corporate Compliance program
- Contribute to policy development and updates, ensuring alignment with regulatory requirements and business practices
- Maintain current knowledge of healthcare compliance laws, enforcement trends, and industry expectations
- Support cross-functional initiatives and coordinate compliance-related projects, including work with external advisors as needed