Senior Director Compliance– North America
Rapidly Growing Commercial International Biotech
HYBRID (in office 1 day per week) Northern, New Jersey
We are representing a rapidly growing commercial International Biotech whose mission is to develop products to treat cancer. We have a robust pipeline of products. The position of Senior Director Compliance N.A. will report to the Global Chief Compliance Officer.
Why Join Us – What We Offer:
• Fast growth company expanding internationally
• Reporting directly to the Global Chief Compliance Officer
• Ample product in the pipeline
• Opportunity to expand your work scope internationally
Senior Director Compliance- N.A. First Year Focus:
• Review compliance program maturity and recommend targeted improvements
• Develop a monitoring program
• Create a needs assessment protocol to retain HCP
Senior Director Compliance – N.A. Responsibilities:
• Provide leadership by serving as a business partner to the commercial and medical affairs functions, understanding business objectives and advising on effective ways to meet the objectives in a compliant manner.
• Lead operational aspects of commercial and medical compliance for the Company, including evaluating needs assessments and overseeing processes for assigning fair market value for HCP engagement activities.
• Stay up to date of the changing compliance landscape and ensure your client group is familiar with compliance standards that govern their operations.
• Maintain the compliance program to continually meet the needs of the company and withstand the scrutiny of government and regulatory expectations.
• Advocate and present key compliance positions to stakeholders as needed and serve as backup for the Chief Compliance Officer when necessary.
• Identify potential risk areas and develop plan of action to address
• Implement and maintain effective policies, training, monitoring, hotline communication, investigations, debarment checks in line with OIG Compliance Program guidelines.
• Identify continuous improvement opportunities for the Compliance Program.
• Manage transparency reporting manager, and the filing of federal, state, and country-level transparency reports.
Senior Director Compliance – N.A. Requirements:
• Bachelor’s Degree… advanced degree preferred
• Relevant life sciences industry experience obtained in Biotech, Pharma, Med Device, Consulting, or Law Firm environment
• Experience in building and implementing an effective compliance program, including policies/procedures, training, monitoring/auditing, hotline protocol, and investigations
• Experience in risk assessment, issue spotting, and risk mitigation
• Knowledge with federal, state, and country-level transparency reporting
• Knowledge of applicable regulatory and compliance requirements (i.e., FDA, OIG, Anti-Kickback Statute, False Claims, HIPAA, GDPR, FCPA).
Application Process:
• Please send your CV and compensation requirements to:maurice@conselium.com
