5 months ago
January 4th, 2021
The Senior Director, Compliance reports to the VP of Legal of our client, a specialist pharmaceutical company, and is responsible for providing legal support to all key business functions and oversight of the compliance program. The successful candidate will ensure business is being conducted in full compliance with all laws and regulations. The Sr. Director is a strong leader who promotes a highly ethical, complaint and accountable culture that encourages and enables employees to raise potential or actual compliance concerns.
• Effectively develops and implements compliance standards through strategic planning, oversight, effective communications, training, and monitoring of policies and controls.
• Leads continuous assessment of the compliance program in collaboration with key business stakeholders and makes recommendations for enhancements and improvements.
• Provides 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.
• Conduct Monitoring and Auditing of transactions and interactions with the healthcare community.
• 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, and other state guidelines.
• Identify opportunities for modernization, innovation, and creative engagement within ongoing compliance projects • 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 training, compliance-related auditing, aggregate-spend, and monitoring plans for sales, marketing and other business activities
• Direct compliance investigations involving potential violations of compliance policies, laws or regulations and overseeing corrective action
• Oversee review of sales training materials, corporate communications, and manage market access initiatives and patient assistance programs.
• Work with contracts department to review agreements from a compliance perspective.
• Coordinate promotional review system and oversee timely submissions of promotional materials to FDA OPDP
Required Qualification & Skills
• 10-15+ years Compliance experience in a pharmaceutical, biotech company or law firm
• Juris Doctorate required and advanced compliance certifications preferred.
• 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.
• Exceptional ethics and commitment to integrity, interpersonal skills, professionalism, and collaboration.
• Ability to demonstrate sound and independent judgement, prudence, and maturity in complex and sensitive cases.
• Knowledge of pharmaceutical compliance laws and regulations, and OPDP regulatory standards related to promotional materials.
• Ability to self-start and self-direct work in a fast-paced high growth environment.
• Strong client orientation with a constructive approach to resolve issues. Builds alliances within and outside of company (including regulators, partners, and customers).
• Excellent written and verbal executive-level communication skills.
• Ability to travel as necessary with field sales force or when conducting/completing investigations.
• In-house experience with consulting cross-functional teams on minimizing risk associated with privacy and regulatory matters in a growth company.