Share Email Opening Title Manager, Corporate Compliance - Monitoring, Investigations, and Reporting  About the Organization kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions.   Description Together with the Corporate Compliance & Business Ethics Department, the Compliance Manager will be responsible for ensuring kaléo maintains an effective compliance program. The Manager will support the department's monitoring, auditing, and internal investigation activities, and will help ensure other risk assessment and mitigation strategies are effectively implemented. The Manager will take significant responsibility for the company's Sunshine and other required reporting and various licensing requirements. Essential Functions/Principal Duties and Responsibilities Develop and maintain expertise and knowledge of industry compliance issues and enforcement activities, applicable laws and regulations, and industry standards (including issues relating to the Anti-Kickback statute, promotional sales issues, and transparency reporting). Develop, maintain and execute a monitoring plan and schedule for key business activities, identify gaps and make observations and recommendations for continuous improvements to policies, procedures, and training based on monitoring findings and key industry compliance learnings. Develop, maintain and execute an auditing plan to evaluate the company's adherence to policies, procedures, training, and laws. Support risk assessments and analyze relevant data to assess compliance risks and recommend mitigating actions. Lead the development and maintenance of compliance-related tools, dashboards, reports, and databases. Deliver oral and written presentations on activities. Identify gaps and make observations and recommendations for continuous improvements to kaléo's compliance program based on key industry compliance learnings and enforcement activities. Support internal investigations, mitigation, and remediation efforts. Support federal and state reporting and required licensing activities.   Open Date 3/15/2019   Position Requirements Educational, Certification or Experience Requirements Bachelor’s degree is required. At least 5 years of professional experience in legal, compliance, or auditing with an emphasis on the pharmaceutical industry. Compliance-related certification preferred but not required. Competency Requirements Experience conducting monitoring, auditing, or investigation activities strongly preferred. Familiarity with legal and compliance issues relating to healthcare business operations and activities (i.e., OIG, PhRMA, FDA, FCPA, Anti-Kickback Statute, False Claims Act, pharmaceutical promotion issues, and transparency). Critical thinker, self-motivated with ability to take initiative, make sound judgments and recommendations, and monitor follow-through. Excellent written, oral and presentation skills. Proficiency with workflow management, process improvement, and data analytics tools is preferred. Proficiency with Concur is preferred. Must be able to multi-task and manage multiple projects effectively. Strong interpersonal skills are required. Ability to travel (up to 25% of time). Other Preferred Experience or Qualifications Masters or other advanced degree is preferred. Pharmaceutical industry experience is strongly preferred.   Exempt/Non-Exempt Exempt   Full-Time/Part-Time Full-Time   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Location Corporate   This position is currently not accepting applications. To search for an open position, please go to http://KaleoPharma.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found -- Follow us See who works here:

 

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