Manager - Government Reporting - United States
- The position is responsible for managing daily operational activities related to the Compliance Department’s government reporting obligations (e.g. Aggregate Spend, Corporate Integrity Agreement (CIA), Risk Evaluation and Mitigation Strategy (REMS), etc.).
- Reporting to an Associate Director, this position interacts regularly with other compliance staff, information technology, and other company business areas and functionally-related departments.
- The position will also interact with external customers including Healthcare professionals, third party/external vendors, and external consultants.
- Directly supports the Associate Director in raising awareness of the Compliance program and fostering accountability for compliance throughout the organization
- Supports the review and timely reporting of all government requirements (e.g. CIA, federal and state reporting, REMS requirements, etc.) while understanding their local and global impact. Works closely with Compliance teams to identify, address, and mitigate any potential risks as needed
- Supports Associate Director with NN A/S collaborations regarding government reporting requirements
- Provides input to enhance systems, processes and technologies for government reporting
- Supports training to employees and third party vendors to timely communicate new government reporting requirements
- Supports the government reporting budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending) as requested
- Supports GSC Bangalore government reporting team as requested
- Maintains understanding of applicable laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance
- Responsible for ensuring that Compliance senior management is informed of compliance issues in a timely manner and encourages the flow of information between Compliance colleagues and lines of business
- Additional responsibilities with government reporting or departmental operational impact as assigned
0-10% overnight travel required
Education, Experience, Knowledge and Skills
- A Bachelor's degree from an accredited institution required.
- A minimum of 8 years overall experience with a minimum of 4+ years’ of pharmaceutical or life sciences experience is required.
- Demonstrates functional knowledge and understanding of the Anti-kickback Statute, the False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements, PhRMA and federal and state aggregate spend reporting requirements.
- Excellent communication and organization skills
- Ability to manage multiple projects concurrently and collaborate across several functional areas.
- The ability to think objectively and use sound reasoning principles
- Knowledge and experience with pharmaceutical aggregate spend solutions, master data management, and data associated with promotional and clinical data, preferred.Supervisory experience preferred.