The Senior Healthcare 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. Job Details: • Draft and disseminate written policies and standard operating procedures related to compliance activities.• Draft compliance communications for print and online distribution. • Assist with maintenance of compliance website and policy database. • Assist with the maintenance of health care professionals’ contracts database.• Participate in the development of the Compliance Training curriculum, courses management and attendance recording.• Maintain documentation and databases of all compliance activities, to include complaints received or investigation outcomes.• Help develop and expand the Compliance risk-based monitoring program.• Perform targeted and repetitive testing as part of the monitoring program.• Review metrics and reporting from across the organization in order to identify emerging or potential risks.• Instruct and update associates on compliance issues and procedures. • Perform other duties as assigned.
Qualifications Knowledge, Skills and Abilities (KSAs)
Ethical, with a strong understanding of compliance risks and a good sense for practical solutions.
Excellent oral and written communication skills.
Ability to interact effectively with associates at all levels in all departments.
Proactive, flexible, responsive and resourceful.
Communicate clearly, concisely and effectively.
Ability to listen carefully and effectively communicate complex topics with different types of potential clients.
Ability to grasp best practices and use them to provide client solutions.
Ability to review and synthesize data into meaningful reports.
Demonstrated ability to quickly establish trust and rapport with other personnel.
Efficient at handling and prioritizing multiple projects in a service-oriented environment.
Bachelor’s degree required, or a combination of prior work experience, education and training. Juris Doctorate and Compliance Certification a strong plus.
6-10 years of direct and practical experience with drafting policies, managing training programs and performing testing and monitoring activities, preferably in compliance or legal business function in the medical devices or pharmaceutical industry required.
Knowledge of laws (FD&CA, Anti-kickback Statute, False Claims Act, Foreign Corrupt Practices Act, HIPAA, and State laws), regulations, industry guidance and best practices regarding compliant sales, marketing, and medical activities is preferred.