Manager - Compliance Monitoring & Operations (Permanent) - NJ

Global pharmaceutical company located in Northern New Jersey seeks a Manager - Compliance Monitoring & Operations (Permanent).  Base salary is competitive, depending on your experience.

Primary Duties

The Manager - Compliance Monitoring & Operations will be a member of the firm's U.S. Ethics & Compliance team, responsible for implementing monitoring and risk mitigation activities as identified in the annual risk assessment.  The Manager will serve as the lead point-person for the firm’s monitoring program in the U.S., including the management of in-house monitoring and engagement of third party vendors. The Manager will also be responsible for supporting the department’s shift to data-driven mitigation and will be responsible for providing regular readouts of observations to support the firm’s neurology and oncology commercial and medical business groups. The Manager will also oversee the due diligence review in the firm’s contract administration management process (e.g., ABAC due diligence, FMV tiering, sanctions screening, etc.). The Manager reports to the Director of Ethics & Compliance and will support other prioritized departmental projects as needed.

Key Roles and Responsibilities:

• Administration of the firm’s monitoring program including but not limited to:
  • Live monitoring of speaker programs
  • Commercial and medical ride-alongs
  • Records reviews of commercial call logs
  • Review of responses to medical information requests
  • Records reviews of payments to HCPs to ensure company process are being followed
• Support Ethics & Compliance oncology and neurology business partners in any investigations that stem from monitoring activities.
• Develop quarterly monitoring read-out reports for the neurology and oncology commercial and medical business groups on monitoring observations, trends, and corrective action plans.
• Manage third party vendor relationships for identified monitoring activities. Responsible for managing the development, implementation, facilitation and evaluation of such vendors.
• Execute on implementation strategies for global monitoring initiatives.
• Liaise with the business on the development of a Commercial Operations group to support the monitoring of sample distribution.
• Support departmental and cross-functional compliance projects as needed.

Requirements

• 3+ years of pharmaceutical/biotech industry experience with Compliance, Legal, or Medical equivalent experience.
• 3+ years of auditing and monitoring experience preferred.
• 1+ years of vendor management experience.
• Bachelor’s degree required
• Strong knowledge of key laws and regulations impacting the pharmaceutical industry including the PhRMA Code; FDA; Anti-Kickback Statute; False Claims Act, OIG/DOJ Guidance; Foreign Corrupt Practices Act; and federal and state transparency and disclosure laws.
• Strong Excel and PowerPoint skills required; experience with Veeva and other CRM systems preferred.
• Excellent written and verbal communication skills, including the ability to translate data into actionable business process improvements
• Strong interpersonal and collaboration skills in order to interface effectively with various cross-functional groups.
• Strong project management skills such as scheduling, planning, and prioritizing several diverse activities, initiatives, and projects from different individuals, groups, or departments.
• Must have demonstrated the development of new and creative solutions to a variety of challenging problems.
• Travel up to 20% of the time.