Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief team/department description:
The Corporate Compliance Manager \will have primary responsibility for Back-End Monitoring (BEM) and related oversight activities at both the strategic and tactical level. This role will manage, coordinate, and conduct data monitoring, support internal investigations and audits, and manage and execute Azurity's Risk Assessment and Mitigation Process (RAMP) and be responsible for Third Party Risk monitoring and mitigation.
Principle Responsibilities:
Monitoring and Oversight:
- Lead and oversee the strategy, development and execution of ongoing Back-End Monitoring (BEM) activities, including document collection, review, oversight, tracking, and follow-up corrective actions. Areas will include activities such as HCP engagements, patient interactions, meals and other transfers of value, and Concur expense data. Ensure achievement of strategic goals.
- Maintain all related Compliance trackers (e.g., Issue Tracker, Management Action Plans, monitoring logs, and other oversight tools) to ensure completeness, accuracy, and timely follow-up
- Perform root cause analysis of noted compliance issues, trending of identified and emerging risks, and tracking of remediation
- Facilitate data collection efforts and analyses related to ad hoc requests from senior members of the Compliance team
- Oversee and review the work of contractors and temporary associates, as needed
Investigations & Audits:
- Provide investigation support, including information gathering, documentation, and coordination with internal stakeholders
- Manage the coordination of compliance audits and Risk Management, including planning, execution, interviews, and documentation of findings and outcomes
Risk Assessment & Mitigation (RAMP):
- Responsible for the Risk Assessment and Mitigation Process (RAMP), including documentation of remediation outcomes, conducting trend analyses, and preparing executive-level reports
Compliance Program Support:
- Maintain Azurity's Compliance incident management and reporting system, ensuring timely documentation, follow-up, and resolution
- Recognize and respond promptly to compliance issues, escalating and addressing concerns to improve processes and communications
- Collaborate across Compliance functions to ensure alignment and consistency in monitoring, remediation, and reporting
- Recommend and implement new and updates to existing functional practices, policies and systems
- Perform other departmental duties as assigned
Qualifications and Education Requirements
- Bachelor's Degree in health science or related field
- 10+ years of compliance experience in the life sciences industry (pharmaceutical, medical or biotechnology) with a Bachelor's Degree
- Full knowledge of healthcare laws and regulations under the FDA, fraud and abuse laws, privacy laws, industry codes
- Excellent analytical and problem-solving skills with the ability to organize and interpret complex data and identify trends to facilitate understanding of key information and provide actionable insights and recommendations
- Understanding of simple statistical sampling methods to facilitate risk-based sampling
- Skilled at effectively communicating findings, trends/patterns, and recommendations both verbally and in writing to leadership and stakeholders through comprehensive reports
- Demonstrated expertise in compliance monitoring, auditing, and issue remediation
- Demonstrated knowledge of regulatory and compliance requirements including Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, Sunshine Act, and other relevant regulations
- Proficiency with Microsoft Office Suite of products; intermediate to advanced level skills in Word, Outlook. Advanced skills in Excel and Power BI (e.g., V-Lookups, Pivot Tables, data queries, visualization, data import and format conversions), PowerPoint (e.g. development of slide decks including text and graphics), and Smartsheet (e.g. case tracking)
- Ability to build professional relationships with internal customers and partners
- Acts with a sense of urgency; high motivation and ability to take initiative, follow through, and complete projects in a professional and expeditious manner
- Proficiency with and/or ability to learn varied industry software products, such as Salesforce, Smart Sheets, Sharepoint, Concur, and similar systems supporting day-to-day compliance operations.
By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
