Compliance Manager

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.

The Compliance Manager is a member of Azurity’s Legal and Compliance team and is responsible for supporting the day-to-day operations of Azurity’s Comprehensive Compliance Program. The Compliance Manager reports directly to the Senior Director of Compliance and will provide support to Azurity’s compliance program, including, but not limited to matters relating to policies and procedures, reporting obligations, the compliance training program and Azurity’s auditing and monitoring program.

Key Responsibilities

• Support the Sr. Director of Compliance in leading the company’s efforts to develop and operationalize ethics & healthcare compliance policies across the company and ensure business activities comply with relevant laws, regulations and ethical standards
• Develop and execute a comprehensive learning strategy that includes reinforcing compliance and ethics education, key messages and optimizes learning and business impact / results
• Drive simplification of learning and identify methods for content delivery while improving the learner experience and engagement
• Establish metrics and key performance indicators to measure and track the effectiveness / impact of learning solution initiatives
• Administering the process for capturing, extracting, reviewing, remediation and analyzing HCP/HCO transfer of value from internal and external sources to ensure compliance with applicable US federal, state and global reporting requirements
• Serve as liaison between third-party service providers and Azurity’s reporting vendor
• Assist with management of HCP engagements, including review of needs assessments, completion of debarment/exclusion checks, fair market value assessments, facilitation of HCP contracting processes and collection of proof of performance documentation
• Assist with management, review, assessment and audit of exhibit and sponsorships requests/activities
• Assist in designing, implementing, and maintaining effective and efficient communication tools, including compliance instructions, updates and other resources for field personnel
• Responsible for Azurity’s “Speak Up” program, raising awareness globally of the Compliance Program.
  
  

Compliance Partnership Support

• Keep apprised of current and future industry laws, regulations, guidance’s, trends and other standards and compliance requirements
• Build strong collaborative relationships with key business teams and stakeholders, external vendors, as well as legal and compliance colleagues
• Support or lead various other compliance projects and initiatives, as assigned
• Maintain Azurity’s compliance program document repository (including compliance policies, supporting procedures, training assets, and guidance documents) and compliance calendar
  
  

Qualifications

• A high sense of ethics, integrity, and teamwork
• Minimum of 5 years of experience in providing compliance/operational support to pharmaceutical/biotech companies, with a minimum of 2 years of spend transparency experience
• Excellent project management skills: exceedingly detail oriented and organized
• Minimum of 2 years of learning related experience in compliance training within the pharmaceutical industry
• Working knowledge of key healthcare compliance requirements for a comprehensive compliance program, particularly U.S. Laws, regulations and applicable industry codes (i.e., OIG/DOJ) guidance; PhRMA Code, FD&C Act, Anti kickback statute, and the False Claims Act
• Advanced Excel and PowerPoint skills
• Demonstrated ability to work independently
• Ability to multi-task with strong sense of urgency and a commitment to meeting deadlines
• Excellent interpersonal, communication, problem-solving and analytical skills
• Flexible and solution-oriented
  
  

Education

• Bachelor's degree required
• Professional certification a plus (e.g. Healthcare Compliance)
  
  

Physical & Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required