The Director Commercial Compliance is responsible for the management of personnel, processes and systems related to federal and state government pricing, Medicaid Rebating, and federal and state aggregate spend reporting. This includes development and sustentation of expertise in the subject matter, corporate and field sales training, compliance reporting and systems implementation.
- Interprets regulations, develops and implements policy related to federal and state pricing and aggregate spend regulations. Is considered corporate subject matter expert. Provides expertise, guidance and support to executive decision makers in matters related to the regulations including risk assessments and appropriate operating procedures to mitigate risk. Prepares presentations and reports for the executive team and board of directors as requested.
- Develops, implements and maintains appropriate processes and systems to support regulatory requirements as they relate to federal and state price reporting and transparency including AMP, ASP, 340B, Best Price and Medicaid Rebating. Ensures timely and accurate reporting and payment as per regulation.
- Develops, implements and maintains appropriate processes and systems to support regulatory requirements as they relate to federal and state Open Payments/ Aggregate Spend. Ensures timely and accurate reporting as per regulation.
- Directs and conducts regular internal audits of policy, data and systems to support company’s compliance with federal and state programs.
- Initiates and delivers related compliance training programs, SOPs and policy for employees in the US and US territories. Ensures training programs and SOPs are updated and reviewed regularly.
- Collaborates with internal and external counsel, Sales and Marketing, Finance, Customer Service and Medical to communicate and drive programs throughout the organization. Develops and maintains strong working relationships with key stakeholders across multiple internal work teams.
- Manages and fosters the growth of the team to support the long term growth and corporate strategies. Oversees full range of performance management processes and training and development needs of functional team. Leads and motivates employees and provides feedback, coaching, and counseling to enhance or improve performance by setting expectations and holding individuals accountable for performance and behavior. Maintains a culture that is focused on compliance with laws, regulations, policies and procedures.
- Working with IT, translates complex reporting and compliance requirements into efficient systems that comply with the needs of the business and meets government regulations. Drives all related projects with IT to ensure implementation is appropriate, within budget and is delivered on time.
- Researches and recommends 3rd party vendor support if needed to fulfill reporting obligations. Maintains relationships and deliverables with 3rd party vendors and provides oversite to ensure an appropriate cost effective engagement.
- Maintain current knowledge of, and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- BA/BS degree with 10 years progressive experience in pharmaceutical compliance programs related to pricing, provider spend and pharmaceutical sales and marketing regulations.
- Experience managing professional staff.
- Exceptionally strong organizational skills including deadline, detail and results orientation to manage workflow for team.
- Experience interpreting legal documents and regulations using proven critical thinking skills to support decision making and evaluate program risk.
- Prefer experience in a busy, regulated environment at a small or mid-size company.
- Prefer experience in role of a business owner in IT related projects who has delivered system implementation and updates.
- Occasional overnight travel based on business need.