Rafael Holdings, Inc., (NYSE: RFL) is a fast-growing company focused on the discovery and development of novel oncological therapeutics to improve and extend the lives of patients through a wholly-owned and controlled portfolio of companies. With multiple clinical programs ongoing including two Phase 3 trials, this is an exciting time to join Rafael.
As we continue to transition from a clinical-stage company toward a commercial enterprise, we seek a skilled attorney for the position of Chief Compliance and Ethics Officer with the experience and drive to be an integral part of this transformation. Reporting directly to the Chief Executive Officer, the Chief Compliance and Ethics Officer will play a key role executing on compliance priorities and shape the corporate compliance function along the way.
- Working cross-functionally to design, implement and enforce Company-wide compliance programs to ensure compliance with the Company Code of Conduct and all applicable U.S. laws, rules, regulations and industry codes, including but not limited to FDA regulations, GXP, privacy laws, federal anti-kickback statute, foreign corrupt practices act, anti-bribery and anti-corruption laws, PhRMA Code, other industry codes of practice related to interactions with healthcare professionals and patients, marketing strategies, promotional tactics and materials, direct to consumer advertising campaigns and programs, healthcare fraud and abuse, and other compliance matters related to our life sciences services business and the development and commercialization of pharmaceutical products.
- Timely and accurate submission of compliance reporting as needed, including the management and coordination with vendors, third parties and others to support the compliance program and activities.
- Support the development of policies, processes and systems that accurately and efficiently identify, capture and record interactions with healthcare professionals (master data) to enable, identify and track spend and other engagements
- Support the Compliance Committee; develop reporting on the status of the corporate compliance and ethics program and risk management activities to the Compliance Committee, Executive Team and/or the Board of Directors.
- Champion an enterprise-wide culture of compliance and business ethics
- Support the development and implementation of controls and oversight for key areas of risk.
- Support the development of a comprehensive privacy program that defines, develops and implements policies and processes to enable consistent, effective privacy practices to minimize risk and ensure confidentiality of personal protected information including protected health information.
- Other activities in support of the Legal and Compliance team, functional, and/or corporate strategies and goals.
- Continuously seek out, and incorporate as appropriate, compliance related industry best practices and learnings.
- Assist in developing, implementing and maintaining an effective Corporate Compliance Program that meets or exceeds regulatory standards for effective healthcare compliance programs, including the Office of Inspector General (OIG) Guidelines, the U.S. Federal Sentencing Guidelines, and the Department of Justice (DOJ) guidance.
- JD degree required and a minimum of ten years of relevant experience in both developing (e.g., strategy, materials, system identification) and then implementing healthcare and corporate compliance programs in the pharmaceutical/biotech industry, including roles in leadership.
- In-depth understanding of the pharmaceutical industry with expertise in the body of laws, regulations, guidance, and codes impacting pharmaceutical companies, including knowledge of compliance issues related to the development and commercialization of branded pharmaceutical products.
- Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including: OIG, PhRMA Code of Conduct, American Medical Association, Federal transparency laws, State disclosure laws, False Claims Act, Anti-Kickback Statute, anti-bribery laws and state price reporting statutes.
- A successful track record building a culture of compliance and ethics in which compliance and business objectives are mutually reinforcing and establishing effective policies, processes, reporting, monitoring, and auditing programs
- Strong problem-solving and decision-making skills with demonstrated ability to think creatively and devise solutions to challenging problems.
- Desire and ability to both develop strategy, make decisions and to implement timely, with hands-on creation and delivery of materials and process.
- Must have excellent analytical skills and comfort with multiple data sets, with the ability to draw conclusions and make informed decisions and recommendations
- Ability to clearly map process and data flows between systems.
- A high sense of ethics and integrity with an approachable and pragmatic style to communication and application.
- Strong sense of accountability and ownership; proactive and self-motivated.
- Highly collaborative; ability to work independently and as a teammate; ability and desire to lead, influence and collaborate cross-functionally.
- Thrive in a fast-paced, lean, highly dynamic environment.
- Ability and willingness to travel.
What You’ll Get
- To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives.
- Opportunities to learn and contribute to creative solutions.
- Competitive compensation package including long-term incentives.
- Comprehensive health insurance (highly subsidized cost sharing on all medical plans).
- Flexible time off policy and holidays.
- Multi-cultural work environment.
Rafael celebrates and supports our differences and is proud to be an Equal Employment Opportunity and workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Rafael is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at firstname.lastname@example.org