Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.

We have a position in Monmouth Junction, NJ for a Manager, Compliance

The Manager, Compliance supports the organization in leading and administration of company’s U.S. commercial compliance program. Reporting to, and collaborating closely with General Counsel, Chief Compliance Officer, incumbent serves as primary interface supporting existing branded commercial product portfolio and growing commercial pipeline. She/he contributes to development and implementation of commercial Compliance policies and practices and works cross functionally with internal departments (i.e., Legal, Commercial, Medical, Clinical Development, Finance, Regulatory Affairs, Human Resources (HR), etc.) to develop communications and training for US commercial employees, in addition to monitoring and auditing ongoing commercial operations to ensure accurate, effective, timely and compliant use of marketing materials, product promotions and other appropriate healthcare interactions.

• Assists in supporting operational and strategic components of commercial compliance program operations across organization to ensure adherence to federal, state, and local regulatory requirements and company/client policies
• Participates and leads developing and implementing comprehensive commercial Compliance Program, including, but not limited to: policies, processes, controls, communications, etc. with respect to supported portfolio, pipeline and risk areas
• Oversees development, implementation and continuous improvement of processes to drive compliant behavior across teams; Establishes roadmaps for future improvement; Assists in identification of short and long-term compliance program initiatives and prioritize immediate needs; Provides compliance policy interpretation and requirements to appropriate end users
• Provides compliance oversight and participate, as required, in review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups
• Conducts, for both office and field territories, periodic internal reviews, risk assessments monitoring and auditing ensuring commercial compliance policies and procedures function as intended and identify potential commercial compliance risks and recommend mitigation and mediation plans where necessary; Identifies specific critical metrics to measure and monitor potential risk areas and facilitate implementation of effective tools to assess indicators; Conducts and participates in investigations and audits into commercial Compliance related issues, allegations or identified risk areas, including documentation and report preparation/review; Ensures consistent and appropriate utilization of investigative processes
• Strictly adheres to ethical and good corporate practices; develops, implements and follows high standards of research and corporate conduct

REQUIRED QUALIFICATIONS

• Bachelors degree and minimum 6 years commercial Compliance/Legal experience in Pharmaceutical, Biotechnology or related industry (minimum 3 of those years directly responsible for developing, implementing and monitoring commercial compliance plans)
• Extensive experience with commercial Compliance matters relating to development, approval and commercialization of pharmaceutical products
• Comprehensive knowledge of U.S. healthcare fraud and abuse laws, Federal Anti-kickback Statute, Federal False Claims Act, U.S. Sunshine Act and state transparency laws, and PhRMA Code OIG Program Guidance for Pharmaceutical Manufactures, pharmaceutical marketing, and privacy
• Ability to apply risk-based analysis to commercial compliance issues and demonstrate knowledge/flexibility in developing solutions satisfying both business requirements and legal obligations
• Experience liaising with Legal and business colleagues and/or outside counsel on complex legal and commercial compliance issues
• Strong working knowledge of, or direct exposure to, pharmaceutical business functions (i.e., Legal, Regulatory Affairs, Government Affairs, Commercial Operations, HR, Finance, etc.)

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI