Job Code:
Location: East Coast

The Commercial Compliance Specialist plays a critical role within the Customers & Markets Operations Group. Through partnership with the legal group the Commercial Compliance Specialist provides guidance, support and advice for any company Healthcare Professional Compliance guidelines related activity. This position will also assist in ensuring that company promotes a culture that encourages ethical conduct and a commitment to compliance with the law, resulting in a positive image to associates, customers, vendors and the community. This is a cross functional role that interacts with Legal, Marketing, Managed Markets, Sales, Government Affairs, Medical Affairs, Commercial Development, and Information Technology.

Key Responsibilities include:

- In collaboration with the Legal department support the implementation of commercial compliance policies, procedures, and controls including selection of applicable systems and audit protocols

- Maintain current Fair Market Value (FMV) analysis and ensure standards are applied to all company interactions with healthcare professionals

- Conduct audits to ensure compliance with applicable policies

- Track all company health care professional related spend and file related reports as required by state and other government agencies

- Serve as a resource, in collaboration with the Legal department, for sales, marketing, managed markets, clinical, and medical affairs departments in all compliance related activities involving interactions with healthcare professionals.

- Develop and conduct training relating to areas of responsibility

- Maintain a current working knowledge of various rules, regulations, and industry guidance that impact Commercial activities, including FDA regulations, OIG guidance, the PhRMA code, and state/federal legislative activities

- Complete ad hoc projects and analysis relating to Customers & Markets Operations group responsibilities

Basic Qualifications

- A Bachelor’s degree with at least 4 years pharmaceutical/biotech industry experience in commercial compliance, legal/regulatory experience a plus

- An established understanding (obtained through 2+ years of working experience) of federal and state fraud and abuse laws, including anti-kickback regulations, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act as well as an understanding of the roles and authority of government agencies and industry cooperative groups including FDA, OIG, and PhRMA

- Extensive experience managing projects related to commercial pharmaceutical/biotech compliance

- Proven ability to negotiate and partner with others to resolve conflicts

- Ability to handle sensitive, confidential matters and exercise sound discretion and judgment

- Solid project management, interpersonal/communication skills

- A track record of success in leading and directing teams to achieve project objectives and goals within assigned timelines

- Demonstrated ability to work independently and manage multiple projects that require collaboration across functional areas

- Ability to function as a team player and develop rapport and credibility with field based, home office, and management personnel