- Job Level:
The Manager of Compliance will be responsible for managing corporate-wide compliance projects and ongoing compliance initiatives, as well as managing the development and implementation of updated compliance processes and programs across the U.S. organization. Works with Legal, as appropriate, to propose solutions to the business for proposed commercial programs. The successful candidate will have Pharmaceutical industry experience and be knowledgeable of U.S. Pharmaceutical laws and regulations and industry standards (the. Anti-Kickback Statute, Food and Drug Administration laws and regulations regarding the promotion of pharmaceuticals (including the Prescription Drug Marketing Act), the False Claims Act, and federal and state transparency reporting requirements (Sunshine Act)).
- Manage the activities of federal and state transparency reporting initiatives to ensure accurate and timely reporting of spend related to health care professionals (“HCPs”) and teaching institutions are submitted in compliance with U.S. and state “Sunshine” laws. Work cross-functionally with stakeholders to identify and collect relevant HCP data. Coordinate collecting and reporting of data to U.S. HCPs from global affiliates and stay abreast of and advise on U.S. transparency laws. Manage relationship with third party transparency vendors.
- Manage field sample operations and sample accountability including policy development, auditing and monitoring, training, investigations and reporting to government entities as necessary. Manage the relationships with third party sample accountability vendor and sample operations vendor. Conduct new hire and on-going sample accountability training.
- Responsible for assisting sales representatives with required institutional credentialing and managing third party vendor relationship for credentialing activities. Responsible for ensuring that field personnel are properly licensed and trained as required by local and state laws and regulations and developing and managing a process for obtaining and maintaining licensure for field personnel with the Human Resources department.
- Responsible for maintaining state manufacturer distributor licenses and managing third party vendor relationship related to distributor licenses.
- Responsible for compliance with local and state safe drug disposal laws, including serving as company representative on product stewardship committee.
- Ensure appropriate communications and training of compliance initiatives are developed and implemented for impacted stakeholders and employees. Conduct new hire training on transparency laws and reporting requirements. Prepare initial compliance training packets for field personnel.
- Assist the Chief Compliance Officer in developing and implementing the annual monitoring and auditing plan.
- Assist the Chief Compliance Officer in conducting and preparing reports related to compliance investigations.
- Assist with other compliance department projects and tasks, as required.
- Minimum of a Bachelor’s degree
Experience & Skills Required
- 3-5 years of experience in a compliance function in the pharmaceutical industry.
- Experience in a people management role
- Knowledge of the Anti-Kickback Statute, Food and Drug Administration rules and regulations regarding the promotion of pharmaceuticals (including the Prescription Drug Marketing Act, the False Claims Act, and federal and state transparency reporting laws (“SUNSHINE”).
- Excellent organizational skills and responsive with demonstrated attention to detail and accuracy.
- Excellent project management skills and ability to work independently.
- Excellent data analysis and reporting skills; ability to review and synthesize data into meaningful reports.
- Excellent oral and written communication skills. Ability to communicate clearly, concisely and effectively.
- Ability to interact effectively with associates at all levels in the organization and global affiliates.
- Proactive, flexible, responsive and resourceful.
- Ability to write reports, business correspondence and policies and procedures
- Familiarity with VEEVA systems and Concur is a plus
- Proficient in Excel, Word and PowerPoint
- Some local travel is required.