- Working with Legal to deliver comprehensive guidance, understanding and interpretation of industry regulations and guidelines as they relate to federal and state programs for CSL Behring FDA licensed drugs.
- Manages multiple federal government programs, and implements associated pricing, calculations and reporting for CMS AMP/ASP reporting, Medicaid rebating/340B pricing, and Federal Supply Schedule.
- Responsible for creating, maintaining and updating all gov't pricing related internal control procedures, Policies, SOPs and Job Aids on a regular basis.
- Oversees and fulfills all Federal and state specific health care provider payment reporting requirements including the new obligations under the Physician Payment Sunshine Act for the KOP site. Coordinates the activities of both internal and external resources to manage the required data collection and submit all reports needed for compliance.
- Provides expertise to the Leadership Team and Pricing Committee on pricing recommendations and examines the impact to the above regulatory requirements.
- Working with IT, translates complex reporting and compliance environment into efficient systems that meet needs of business and government requirements. Leverages understanding of complex sales analyses and systems to contribute to the development and deployment of innovative approaches and capabilities that are critical to the functional and business strategy.
- At the request of the Legal Department, gathers data in response to state/federal inquiries and investigations.
- Provides expertise to the Corporate Compliance Department on audit and monitoring activities related to the above mention regulations.
- Provides management oversight on the records supporting the disclosure of data to federal and state agencies. Ensures compliance to federal record retention requirements.
- Collaborate with Manager Customer Support, Director Pricing, Director Contracting and Director Finance on design and implementation of pricing strategy, tactics, policies and procedures.
- Has responsibility for oversight and effective management of all team members (i.e. directreports) to include but not limited to the following:
- Annual objective setting
- Mid-year and end of year reviews
- Coaching and counseling as appropriate
- Employee development
- Recruitment, selection and development of talent
- Managing, directing & measuring work on an ongoing basis. Provides timely constructive feedback to ensure quality of work meets or exceeds company standards
- Assuring work is completed in a customer focused manner
Requires a Bachelor’s degree, preferably in Business, Life Sciences, or Healthcare Policy and 8 – 10 years of biotech/pharmaceutical experience
Strong knowledge of the regulatory requirements for Veteran’s Healthcare Act, the Medicare Modernization Act, Deficit Reduction Act, Patient Protection Affordable Care Act, Physician Sunshine Act and other federal regulations mandating price and/or expenditure disclosures.
Strong knowledge of federal healthcare programs, especially Medicaid and Medicare.
Experience with implementation and utilization of pricing systems. ModelN preferred.