US Compliance Business Partner (Research & Development & Pain), Associate Director (Hybrid)

US Compliance Business Partner (Research & Development & Pain), Associate Director (Hybrid)

Why Join Us?

Vertex is a transformative biotechnology company that creates new possibilities in medicine to transform diseases and improve people's lives. The company currently has five drugs on the market that treat the underlying cause of cystic fibrosis, one drug on the market that is a cell and gene therapy treatment for sickle-cell disease and transfusion-dependent t -thalassemia, and one drug on the market for the treatment of acute pain. It has also developed a deep pipeline, investing billions of dollars into R&D over the past two decades.

Vertex is seeking an experienced Legal and Compliance professional to join its Office of Business Integrity & Ethics (OBIE) as the Compliance (OBIE) Business Partner for Global Research & Clinical Development. This individual would also be responsible for helping to support the US Pain Business Unit. OBIE is responsible for the development, implementation, oversight, and continuous improvement of Vertex's Compliance Program. This includes defining standards via policies and procedures, creating, and implementing training and communications, conducting auditing and monitoring and other assurance activities, facilitating internal reporting, discretely and professionally conducting compliance-related investigations, and keeping the CEO, the Executive Committee, and the Board of Directors informed on compliance matters. OBIE serves as the go-to experts for Vertex employees and external stakeholders on issues relating to Vertex's Compliance Program and Code of Conduct globally.

Job Summary

The person in this role will provide clear and actionable analysis, guidance and counsel to Vertex's Global Research & Clinical Development colleagues as well as colleagues within the Pain Business Unit on a broad array of strategic and tactical projects. The ideal candidate will have prior experience providing advice and guidance to prescription drug companies on legal issues relating to scientific exchange, external funding, patient support programs, and interactions with healthcare professionals and patient organizations. This role supports and reports to the Executive Director, Senior OBIE Business Partner Global/North America and works closely with OBIE Global, North America, International, and Operations colleagues providing clear and actionable analysis, guidance, and advice on the Program.The Business Partner must have strong, demonstrated knowledge of laws, regulations, and codes applicable to the pharmaceutical industry, including the US and international anti-bribery/anti-corruptions laws such as the Anti-Kickback Statute, False Claims Act, and Foreign Corrupt Practices Act and experience providing advice and counsel to biotechnology/pharmaceutical companies on these issues. Additionally, the Business Partner will work collaboratively with colleagues in OBIE, Legal, and the business to drive a culture of ethics and integrity across Vertex's global organization.

you thrive in a dynamic, fast-paced, hands-on, and team-oriented environment where you can have a big impact on patients in need, their communities, and our organization, we'd love to speak with you!

Key Responsibilities

• Advise Global and North America business colleagues in Research & Clinical Development and the US Pain Business Unit on various initiatives in a way that advances the company's strategy while addressing legal and compliance risks and protecting the company's integrity and reputation.

• Serve as the Compliance representative on leadership and cross-functional teams, providing strategic and tactical guidance and advice on projects and initiatives to drive fact- and risk-based decision making.

• Collaborate with the OBIE Training and Communications team on substantive trainings and regular communications on Compliance policies, procedures, and areas of risk.

• Maintain a high level of knowledge of current and emerging laws, regulations, codes, and recent enforcement actions across the US and inform and educate business colleagues with tailored communications.

• Help to establish standards and implement procedures to ensure the Compliance Program is effective and efficient.

• Develop and maintain strong relationships and collaborate frequently with Legal, Human Resources, Internal Audit, and colleagues in other functional areas both in and outside of the US.

• Support continuous improvement of the Global Compliance Program.

Qualifications, Professional Skills, and Preferred Experience

• 5-7 years post-JD experience providing legal counsel in the biotechnology/pharmaceutical industry, including both in-house at a global biotechnology or pharmaceutical company (strongly preferred) or a combination of law firm and in-house experience.

• Outstanding ability to effectively communicate sound advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs.

• Expert knowledge of statutes, regulations, and guidance documents applicable to commercial, development and medical affairs activities, including research and interpretation of the Food, Drug, and Cosmetic Act; FDA regulations and guidance; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; the False Claims Act; and the PhRMA Code and extensive experience providing legal counsel on these topics.

• Demonstrated commitment to Compliance, ethics, and accountability.

• Flexibility to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude.

• Ability to travel on an as-needed basis.

• Proficiency in MS Office (especially PowerPoint, Word, and Excel).

• Law degree and legal experience required.

Personal Attributes

• Consummate team player with excellent judgment and interpersonal skills.

• Ability to communicate, present, and train effectively with all levels of management and employees.

• Demonstrated experience taking ownership of issues and providing timely, practical, and actionable guidance.

• Strong oral and written communication and influencing skills and the ability to collaborate cross-functionally proactively and pragmatically.

• Strong analytical, organizational, and problem-solving skills.

• Excellent project management skills with the ability to manage multiple priorities simultaneously.

• Self-starter with demonstrated leadership skills and ability to meet goals; able to exercise sound judgment in balancing risks in ambiguous and complex situations and escalating matters appropriately.

• Demonstrated superior ability to identify areas for improvement in controls, systems, and processes and implement effective solutions.

• Ability to work with large amounts of data to analyze information while still seeing the "big picture."

• Confidence and professionalism to handle difficult conversations and discretion on sensitive matters.