Director, Compliance Business Partner

About the role

The Office of Business Integrity & Ethics (OBIE) at Vertex is responsible for developing, implementing, overseeing, and continuously improving the company’s Global Compliance program. OBIE serves as the go-to experts for Vertex employees and external stakeholders on issues related to the Compliance program and Code of Conduct globally.

Responsibilities

• Advise Global and US business colleagues on initiatives in a way that advances the company’s strategy while identifying and mitigating risk and protecting the company’s integrity and reputation.
• Provide timely, practical, and effective oversight, guidance, and direction for business colleagues and identify areas where Compliance input and attention are required.
• 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 and trainings.
• 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.
• Help to establish standards and implement procedures to ensure the Compliance program is effective and efficient.
• Support continuous improvement of the Global Compliance program.

Requirements

8-10 years post-JD experience providing counsel in the biotechnology/pharmaceutical industry, including both in-house at a global biotechnology or pharmaceutical company supporting disease areas in competitive markets (strongly preferred) or a combination of law firm and in-house experience.

Advanced knowledge of statutes, regulations, and guidance documents applicable to the biopharma industry, including 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 counsel on these topics.

Demonstrated commitment to Compliance, ethics, and accountability.

Outstanding ability to effectively communicate sound advice coupled with a strong understanding of business needs.

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.

High level of proficiency in MS Office (especially PowerPoint, Word, and Excel).

Qualifications, Professional Skills, And Preferred Experience

• Law degree and legal experience strongly preferred.
• Demonstrated commitment to Compliance, ethics, and accountability.
• Outstanding ability to effectively communicate sound advice coupled with a strong understanding of business needs.
• 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.
• High level of proficiency in MS Office (especially PowerPoint, Word, and Excel).