Head of Standards & Governance leading compliance for U.S. Commercial activities. Directing risk management and adherence to regulatory standards while collaborating with cross-functional teams.
Responsibilities
Oversee compliance with Federal and State Transparency laws through team-managed activities
Lead the sub-certification process with VP+ cross-functional leaders in various departments
Manage error management and remediation processes
Drive data review, reconciliation, and submission to CMS
Develop and implement regulatory, legal, and commercial compliance controls
Create and provide training and guidance for business practices
Support the annual risk assessment and execute risk mitigation plans
Serve as the first point of contact for Standards & Governance questions
Review compliance dashboards and escalate red flags to US Compliance
Support internal and third-party auditing processes
Develop and oversee compliance action plans and corrective actions
Provide leadership to achieve departmental business results and develop an exceptional workforce
Present compliance related topics and updates to senior leadership
Requirements
Bachelor's degree required, MBA or graduate degree preferred
10+ years of experience in the Pharmaceutical/Biotech industry
In-depth knowledge of transparency reporting requirements (Sunshine Act, State Law)
Deep understanding of data collection and reporting systems supporting reporting requirements
Familiarity with laws, regulations, and industry guidance affecting the biopharmaceutical industry
Proven leadership skills with expertise in influencing across a matrix and managing multiple priorities
Benefits
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
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