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Years of Experience
Date Last Verified
ProfileDirector Compliance The candidate will have a significant role in the design and development of the U.S. healthcare compliance program as well as the implementation of the corporate compliance program in the U.S. Will assist on development of written policies, procedures, practice directions, training and education as well as related communication, monitoring and reporting. Assisting the Executive Director, Compliance Officer, and Chief Compliance Officer with ensuring obligations under the Company’s Corporate Integrity. Agreement are met and liaising with the Independent Review Organization regarding same. Assist the Vice President, US Compliance Officer and the Chief Compliance Officer with monitoring evolving federal, state and industry guidelines affecting the company’s overall U.S. healthcare compliance program and adopting and implementing processes and procedures in order to ensure ongoing compliance. Work closely with the scientific and medical affairs groups and the commercial groups (such as sales and marketing), providing both compliance oversight (including an audit function) and supporting operations as a value added business partner. Develop and execute a plan for development of additional polices (if required), SOPs, guidance, etc. based on prioritized needs in coordination with the SVP, Chief Compliance Officer and the heads of impacted departments. Act as the point of contact for scientific and medical affairs and sales and marketing and on all compliance-related issues. Develop and execute a plan for ensuring compliance with federal and state requirements. Organize the retention, organization and document management of an official set of compliance records including relevant policies, SOPs, guidance etc. Documentation and records evidencing compliance with relevant policies, SOPs, guidance, and state and federal requirements and the Corporate Integrity Agreement. Develop and roll-out Compliance training to Sales, Marketing and other relevant departments. Subject matter responsibility for: U.S. healthcare law and related compliance requirements; U.S. Privacy law and related compliance requirements; U.S. laws on specialty pharmacy and patient assistance programs and related compliance requirements. Assist with U.S. training efforts.
Qualification and Experience
The candidate must have 5+ years U.S. healthcare compliance experience at a recognized pharmaceutical or device company. Must have ability to effectively communicate and work with many disciplines and cross the organization including Valeant’s Executive Team. Ability to apply management and leadership skills to attain and maintain compliance in a cost-effective manner while building value added relationships with the business is required. Some internal audit experience is required. Bachelors Degree with a masters degree/law degree preferred.
Job ID 5461