Compliance Specialist

Location




Headquarters


Req Number



OCD-174


City




Louisville


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At US WorldMeds, we hold a fundamental belief that our science has the potential to improve patients' lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet medical needs.



US WorldMeds' commitment to patients is reflected in all that we do. We are a company driven by the knowledge that our work is important; we have the desire to make a difference. We offer our employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.



SUMMARY:



The Compliance Specialist oversees the Corporate Compliance Program, functioning as an objective body that reviews and evaluates compliance matters within the Company to assure an effective Compliance Program. This position shall assure that systems are monitored, and systematically reviewed for compliance with the rules and regulations governing the Companys products, programs, and the behaviors of its employees and contracted third parties. The Compliance Specialist is responsible for the oversight of Open Payments reporting as well as transparency reporting requirements of other U.S. states and emerging transparency requirements globally.


DUTIES AND RESPONSIBILITIES:
The following reflects managements expectations and anticipated functions of this job, but does not restrict the tasks that may be assigned.

Develop, initiate, maintain, and revise policies, procedures and standards of conduct for the general operation of the Compliance Program to assure legal and ethical conduct by the Companys employees and third-party service providers and suppliers

In conjunction with the Compliance Officer, act as an independent body to investigate, review, evaluate, and resolve compliance related issues or concerns

Monitor and coordinate compliance activities within departments to remain abreast of compliance activities and to identify trends for further evaluation and remediation

Identify potential risks and recommend corrective/preventive action measures to minimize risks

In conjunction with the Compliance Officer, implement various Compliance Program initiatives

Ensure that Compliance Program objectives are communicated throughout the Company and that Company employees receive appropriate and effective training

Keep apprised of legal and regulatory changes and industry best practices regarding compliance and implement continuous enhancements to the company compliance program accordingly

Work with Sales and Sales Management to ensure proper and consistent compliance training and consistency of compliance related communications

Assist with filing of required aggregate spend disclosure reports in compliance with applicable laws and regulations, including the Open Payments / Sunshine Act

Ensure compliance with applicable aggregate spend and transparency laws and regulations, both state and federal

Work with Finance to develop a process that supports data reporting accuracy and timeliness, including drafting and updating policies and training

Audit and monitor internal data relating to the Company's aggregate spend and transparency reporting program

Research inquiries received from covered recipients regarding transaction reports and handle dispute resolutions with covered recipients concerning aggregate spend/transparency reporting matters

Work with Finance, IT, and outside vendors to develop, implement, and maintain solutions to transparency reporting standards

Act as subject matter expert on aggregate spend reporting, providing guidance to the business

QUALIFICATIONS:


Bachelors Degree (BA or BS) or equivalent

Five or more years of experience and/or training, or equivalent combination of education and experience in operational, quality systems, quality controls, financial controls, compliance, regulatory policy development or controls, project management.

Knowledge of methods and techniques for risk management, business impact analysis, corrective action/preventive action, contingency planning.

Ability to understand and apply standards of conduct procedures, OIG Guidances, FDA Regulations and Guidances, and other related agency regulations and guidance documents.

Ability to interpret and apply government legislation.

Proven ability to influence business change in a developing corporate environment.

Excellent oral and written communication skills.

Strong organization skills.

US WorldMeds' is an equal opportunity employer. US WorldMeds' does not discriminate in any aspect of its employment opportunities or practices on the basis of race, religion, gender, national origin, age, disability, or any other characteristic protected by law.

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