Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Louisville, Kentucky
The Compliance Officer oversees the Corporate Compliance Program, functioning as an objective compliance expert that reviews and evaluates Company compliance with Federal and State rules and regulations, industry standards, and mandated compliance.
US WORLDMEDS: A specialty pharmaceutical company that develops, licenses, and brings to market unique healthcare products designed to improve the lives of patients with challenging conditions and unmet medical needs, located in Louisville KY.
* Develop and implement policies, procedures and practices designed to ensure compliance with Federal health care program and FDA requirements.
* Serve as the Chairperson for the Compliance Committee and quarterly meetings.
* Develop, initiate, maintain, and revise policies, procedures and standards of conduct for the general operation of the Compliance Program.
* Act as an independent individual to investigate, review, evaluate, and ethically resolve compliance-related issues or concerns.
* Identify and evaluate trends in Federal and State regulations and enforcement actions for potential implementation.
* Assure that Compliance Program objectives are communicated throughout the Company and that Company employees receive thorough and effective compliance training.
* Work with the Sales force and Sales force management to ensure proper and consistent compliance training, management of samples, and consistency of compliance related communications throughout the sales organization.
Bachelor s 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, 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 organizational 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.