The Sr. Director, Healthcare Compliance Counsel will report to the Chief Compliance Officer. The position includes management and oversight of the Company’s Healthcare Compliance Program, with significant interaction with Sales and Marketing, Legal, Information Technology, Medical Scientific Affairs, Regulatory Affairs, and other company departments.
Partner with company departments to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees
Increase awareness of the importance of the healthcare compliance program, and maintaining and expanding visibility of the healthcare compliance program throughout SunPharma; provide general guidance to the business and integrate compliance controls into the scope of existing business practices company-wide
Develop, implement, maintain and regularly assess key policies and procedures to mitigate identified risks and to meet government, industry and company healthcare compliance requirements
Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state fraud and abuse and anti-kickback statutes, government price reporting laws, OIG and PhRMA guidelines, state marketing compliance laws
Provide oversight and guidance to department members regarding obligations and submissions federal and state authorities regarding applicable transparency (“Sunshine”) laws
Develop, maintain, enhance and administer effective compliance training programs through various delivery formats that focus on the elements of the compliance program and seek to ensure that appropriate employees understand, and understand the importance of compliance with, pertinent requirements
Collaborate with Company management and other personnel to identify and provide ongoing risk assessment of existing and emerging business practices for potential areas of compliance vulnerability, and develop/implement preventive active plans to help maintain compliance, and where necessary develop and implements corrective action plans for the resolution of issues
Provide regular updates and reports to the Chief Compliance Officer, the Compliance Committee, and senior and executive management on the operation and progress of compliance efforts and initiatives, audit findings, investigation outcomes, and project status updates
Oversee and implement compliance-related auditing and monitoring plans for sales, marketing and other business activities
Assist in management of compliance investigations involving potential violations of compliance policies, laws or regulations and overseeing corrective action
Serve as a subject matter expert in areas of healthcare regulatory law, including rules and regulations of the FDA, OIG and CMS and applicable anti-kickback, fraud and abuse, and statutes and regulations
Oversee review of sales training materials, corporate communications, and manage market access initiatives and patient assistance programs.
Provide advice on market access initiatives and patient assistance programs;
J.D. from a law school accredited by the American Bar Association (ABA)
Expertise in the area of pharmaceutical industry healthcare compliance with a proven record of accomplishment in the areas of drafting and implementing compliance policies, training, auditing, monitoring, and investigations;
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws
Expertise in commercial healthcare, and FDA regulatory law and regulations, including expertise in FDA labeling and promotional requirements, healthcare fraud and abuse laws, and other laws and regulations related to the sales and marketing of pharmaceutical products;
Admitted to practice law in one or more states.
8 – 10 years of pharmaceutical company compliance experience;
Ability to work in a fast-paced environment and to handle multiple complex and confidential tasks