Job Description

Primary Function of Position

The Healthcare Compliance Operations Manager is responsible for supporting the growth, enhancement, and maintenance our corporate compliance program. The role requires basic familiarity with and understanding of the laws, rules, and regulations applicable to healthcare companies. Organizational skills and the ability to proactively coordinate different projects are fundamental. The role will be responsible for policy and procedure preparation and storage, data compilation and analysis, training materials, employee testing and surveys, auditing and monitoring activities, and general record keeping. This role will collaborate with large teams consisting of business, finance, audit, legal, and human resources colleagues in a matrixed environment to ensure support and execution of our global compliance and ethical obligations.

Essential Job Duties

• Supporting the global Compliance team on business goals and objectives while building and maintaining necessary compliance and ethics policies and procedures by, among other things, assisting with the drafting, revising, and implementation of policies, procedures, and processes;
• Supporting the development, modification, and delivery of live and virtual training to educate and test employees on a broad range of compliance and ethics topics, and assisting with the administration of the learning management system;
• Conducting or supporting risk assessments, audit activities, third-party relationship management, and due diligence;
• Proactively monitoring business activities, including Sales field monitoring, Marketing activities, research and development studies, and sponsorship, grant, and donation activities;
• Assisting with internal investigations and corrective action and remediation activities; and
• Supporting the development of control systems to prevent or manage violations of legal guidance, laws, or internal policies.

Qualifications

Required Skills and Experience

• Minimum of five years compliance experience, preferably at least partially in the medical device or pharmaceutical industries.
• Knowledge and understanding of applicable compliance and ethics requirements and compliance risk-management practices and methodologies, including risk assessment, auditing, and monitoring, and activities.
• Knowledge and experience in supporting training, education, and communication processes and programs.
• Experience with applicable laws and regulations such as the Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, Food, Drug, and Cosmetic Act, Sunshine Act, and Federal Acquisition Regulation preferred.
• Experience supporting compliance investigations and implementing remediation.
• Solid organizational skills, project management experience, problem-solving abilities, and attention to detail required.
• Professional, considerate, optimistic and positive, and motivated to work independently.
• Ability to develop and implement cross-functional, global processes.
• Some travel will be required.

Required Education and Training

• Minimum BS/BA required.