The Compliance Specialist participates and supports the development and implementation of the formal corporate compliance program. Responsible for drafting policies and procedures and developing a compliance training curriculum. Assists the Compliance Officer in implementing internal controls, performing continuous monitoring and testing, and maintaining databases of all compliance activities. Interfaces between the legal, business and operations teams to ensure all relevant laws and rules are understood and complied with. 1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 2. Draft and disseminate written policies and standard operating procedures related to compliance activities. 3. Draft compliance communications for print and online distribution. 4. Assist with maintenance of compliance website and policy database. 5. Assist with the maintenance of health care professionals’ contracts database. 6. Participate in the development of the Compliance Training curriculum, courses management and attendance recording. 7. Maintain documentation and databases of all compliance activities, to include complaints received or investigation outcomes. 8. Help develop and expand the Compliance risk-based monitoring program. 9. Perform targeted and repetitive testing as part of the monitoring program. 10. Review metrics and reporting from across the organization in order to identify emerging or potential risks. 11. Instruct and update associates on compliance issues and procedures. 12. Perform other duties as assigned.
Requires a four-year college degree and a minimum of five years of experience with drafting policies, managing compliance training programs and performing testing and monitoring activities in compliance or legal business function. Intermediate computer software skills, i.e. Microsoft Office. Medical device or pharmaceutical experience preferred.