Role Overview:
Manager, Corporate Compliance serves as a strategic compliance business partner to BioMarin’s US Commercial and Medical organizations, providing practical, risk-based guidance to ensure alignment with healthcare laws, regulations, and internal policies; educates stakeholders on compliance guardrails and monitors field activities.
Key Responsibilities:
- Advise Commercial and Medical teams with 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 for initiatives including field activities, patient programs, advisory boards, and HCP engagements.
- Draft legal/compliance analyses and guidance memoranda for business stakeholders.
- Identify compliance risks and develop pragmatic mitigation strategies.
- Design and deliver targeted compliance training; translate complex regulations into actionable guidance; provide ongoing coaching and real-time guidance.
- Support development/maintenance of compliance policies, procedures, and tools.
- Monitor field/business activities (patient events, advisory boards, speaker programs, hub interactions) via live and/or retrospective reviews.
- Partner on follow-up, training, and remediation based on monitoring outcomes; support continuous improvement of the monitoring program.
- Drive data-driven monitoring using enterprise data/AI to detect risks and improve monitoring effectiveness.
- Support development, implementation, and maintenance of the US Corporate Compliance program and coordinate compliance projects.
Qualifications:
- Bachelor’s degree required.
- 6–10 years of experience in pharmaceutical/biotech/healthcare compliance, legal, or regulatory roles.
- In-house, law firm, consulting firm, or regulatory agency experience preferred.
- Familiarity with Commercial and/or Medical Affairs required.
Key Capabilities & Attributes:
- Independent work, strong judgment, risk-based decision-making; ability to manage ambiguity.
- Strong business partnering and communication skills; collaboration in matrixed environments.