Share Email Opening Title Manager, Corporate Compliance - Policies and Training  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; Medical, Legal and Regulatory Review (MLR), Fair Market Value; Sponsorships and Exhibits; Ad Boards; PDMA). Assess training needs for business groups, provides input into training plans, develop, maintain and execute compliance related training materials for specific business areas based on risk, monitoring and auditing findings and industry best practices. Support risk assessments and analyze relevant data to assess compliance risks, industry enforcement actions. Provide day to day support, advice and problem-solving expertise to applicable businesses to ensure activities are conducted in full compliance with all relevant policies and procedures. Develop, maintain and revise policies and procedures for the operation of the Corporate Compliance Program and its related activities to prevent illegal, unethical or improper conduct. Deliver oral and written presentations and training. Identify gaps and make observations and recommendations for continuous improvements to kaléo’s compliance program based on key industry compliance learnings and enforcement 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, transparency, and PDMA). Critical thinker, self-motivated with ability to take initiative, make sound judgments and recommendations, and monitor follow-through. Excellent analytical, written, oral and presentation skills. Proficiency with workflow management, process improvement, and data analytics tools 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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