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Years of Experience
Date Last Verified
ProfileDirector of Healthcare Compliance Responsibilities : The candidate will be responsible for the development and implementation of key elements of a healthcare compliance program with a focus on policies and investigations. Will be responsible providing compliance oversight, guidance and direction to Commercial and Medical Affairs. Develop and maintain relevant policies, SOPs, work instructions, and training plans related to key areas within healthcare compliance, particularly Medical Affairs and Commercial activities, grants and advisory boards. Monitor applicable legal and regulatory developments, industry standards and business developments to determine compliance trends, identify key risk indicators and provide thought leadership on best practices and innovations in investigation, auditing and data analytics; manage compliance investigations and corrective actions. Develop and manage compliance strategy, plans, and processes to ensure activities are conducted in accordance with international, federal, and state laws and regulations, and industry guidance. Develop and provide compliance oversight in key business activities. Partner with Medical Affairs, Clinical and Commercial, to identify areas where compliance input and guidance is required, with focus on scientific publications, grants and advisory boards.
Qualification and Experience
Requirements : The candidate should have a J.D. degree. 10 or more years of experience with a biotechnology or pharmaceutical industry, with practical experience. Comprehensive working knowledge of applicable laws and industry guidance relating to healthcare and life science, and familiarity with the current life science marketplace. Thorough understanding of healthcare compliance law (Anti-Kickback, False Claims Act, Foreign Corrupt Practices Act, HIPAA, Sunshine Act). Must have a good understanding of healthcare compliance laws and regulations, including interactions with and payments to healthcare professionals. Must be a proven self-starter with the ability to work under limited supervision, who seeks to be part of an innovative and dynamic team. This position will be instrumental in cultivating a culture of compliance.
Sound judgment, and strong commitment to ethical conduct and integrity. Practical understanding of healthcare compliance requirements with the ability to provide appropriate guidance to team members. Strong problem solving skills with the ability to identify relevant risks and propose solutions that consider relevant business objectives and compliance concerns. Clear and concise interpersonal and verbal communications skills, and the ability to communicate effectively with a variety of personnel at all levels both internally and outside the company. Ability to work independently in a fast-paced and dynamic environment. High attention to detail, excellent organizational skills, and the ability to work on multiple projects with tight timelines.
Job ID 8102
852 Winter Street
Waltham, MA 02451