Share Email Opening Title Corporate Compliance Specialist  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 Specialist will be responsible for ensuring kaléo maintains an effective compliance program by supporting its internal monitoring and auditing program; building collaborative relationships with business stakeholders through various projects; responding to detected issues and identifying opportunities for policy, process, and program improvement; and assisting with various reporting and 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. Identify opportunities to improve kaléo's compliance program based on key industry compliance learnings and enforcement activities. Partner with appropriate stakeholders to implement improvements. Assist in developing and maintaining monitoring and auditing reports and databases. Assist in identifying trends to support decision making. Support internal investigations, mitigation and remediation efforts as needed. Support federal and state reporting and required licensing activities as needed. Support and partner with business stakeholders to guide and support business on compliance issues.   Open Date 3/1/2019   Position Requirements Educational, Certification or Experience Requirements: Bachelor’s degree At least 5 years of professional experience in compliance, monitoring or auditing or related field Preferred Qualifications: Pharmaceutical industry experience is strongly preferred Compliance-related certification Competency Requirements: Experience conducting monitoring or auditing activities 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 Growth mindset with desire to grow and learn new skills and expertise Ability to review and summarize technical data for a variety of audiences Ability to work independently and make decisions but with the judgment to know the situations where supervisory input is essential Strong interpersonal skills and the ability to develop strong working relationships and work collaboratively A high sense of urgency and ability to work in a lean, agile environment Excellent planning and organizational skills to work within date-sensitive deadlines   Exempt/Non-Exempt Non-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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