Job Description

The Specialist, Compliance Operations has the primary responsibility for planning, developing, conducting, documenting, and reporting transactional testing activities and field monitoring activities as required by the OCA Compliance Management System, to evaluate effectiveness and identify and report vulnerabilities, using monitoring and transactional testing methods of inquiry, observation, re-performance, inspection, analytics, and confirmation. The incumbent will be responsible for supporting the scheduling, planning, execution, and evaluation of the annual Compliance monitoring and testing plans and will independently test, assess, and evaluate adherence to applicable internal policy and procedure requirements and identify matters requiring action and ensure timely reports and resolutions. The incumbent will also be required to lead or assist with the written standard document management process and on Compliance projects with internal and external stakeholders, to help ensure that the OCA Compliance Management System remains effective and current. Emphasis will be on understanding compliance risks, and analyzing key information obtained from OCA entities, groups and functions, including but not limited to HCP Consulting Management, Sales and Marketing, Professional Education, Medical and Scientific Affairs, and Third-Party Management activities, identifying risks, and reporting results.

Job Duties

• Facilitate and administer the Compliance written standard document management activities. This includes the development, maintenance, review by subject matter representatives, formatting, version controlling, and publishing of OCA Compliance written standards.
• Assist in the continuous improvement, design, execution, and compliance with the OCA Compliance monitoring & transactional testing plans.
• Conduct and evaluate in-person, virtual, and records review / data monitoring of field employees activities and company records relating to interactions with health care professionals for adherence with Compliance requirements and controls and document results timely.
• Plan and conduct transactional testing and detailed records reviews of records, business processes, and systems relating to interactions with health care professionals and third-party relationships to test adherence to OCA policy and procedure requirements and controls and document and report results timely.
• Partner with key business stakeholders to understand risk priorities and support the further enhancement of the OCA Compliance monitoring and transactional testing plans.
• Develop an intimate understanding of key business activities, practices, processes, and systems, including but not limited to sales, marketing, service, professional education, HCP consulting arrangements, grants, donations, distributor and other third-party relationships, to facilitate risk-based assessment of business processes and to conduct effective monitoring and testing.
• Perform regular and meaningful analysis and follow up regarding status and results from monitoring and testing activities.
• Develop reports and documentation relative to Compliance monitoring and testing, processes, controls and standards, such as Compliance Department procedures, work instructions, and other control documentation as needed.
• Prepare regular reports and engage in frequent and effective communications, both written and verbal, with the CCO and Compliance Officer Team and business stakeholders, regarding monitoring and testing activities and results, important Compliance issues, corrective actions, date-sensitive information, and important Compliance priorities.
• Demonstrate and maintain a working knowledge of federal, state and international Compliance laws, rules and regulations.
• Other responsibilities as directed by the CCO or Compliance Leadership Team as appropriate and consistent with the role of the position.

Job Qualification

Required:

• Bachelor’s degree or equivalent combination of education and experience required.
• A degree in accounting, business or computer science or other scientific field of study an advantage.
• Minimum of two years’ experience monitoring, testing, auditing, regulatory/quality and/or examining corporate business activities .
• Medical device or quality related business activities an advantage.
• Ability to travel domestically or internationally up to 50%.

Preferred:

• Proficient understanding of fraud and abuse, anti-kickback, or other health care compliance laws, rules and regulations applicable to medical device companies strongly preferred.
• Proficiency or fluency in spoken and written Spanish desired.
• Demonstrated strong project management capabilities, including coordination of requests for proposals.
• Strong analytical reasoning, problem solving, research, and critical thinking skills in areas of heightened regulatory risks necessary.
• Proficient experience with data analytic and software and applications such as PowerBI, ACL, Access, Excel, and Word, especially in an SAP environment would be an advantage.