Director, Compliance Business Partner Medical Affairs, Clinical Development & Global Clinical Operations

Job Description

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 approved products in cystic fibrosis, acute pain, sickle cell disease, and beta thalassemia. It has also developed a deep pipeline, investing billions of dollars into R&D over the past two decades.

Vertex is seeking an experienced Compliance professional to join its Office of Business Integrity & Ethics (OBIE) as Director, Compliance Business Partner supporting its Global and North America Medical Affairs, Clinical Development, and Global Clinical Operations teams.

OBIE is responsible for the development, implementation, oversight, and continuous improvement of Vertex's Global 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.

The Business Partner is a hybrid role that provides dedicated support to Medical Affairs, Clinical Development, and Global Clinical Operations colleagues across Global and North America teams and supports key OBIE departmental initiatives, projects, and needs. This will involve serving as the Compliance representative on cross-functional teams, supporting new product planning and launches, and leading project-based activities. The Business Partner will collaborate with the Training and Communications team on regular communications as well as substantive trainings on Compliance policies and procedures and will support auditing and monitoring activities by the OBIE Assurance team.

This role supports and reports to the Executive Director, Senior OBIE Business Partner Global/North America and works closely with OBIE Global, North America, and International colleagues to implement and continuously improve our Compliance program.The Business Partner must have strong, demonstrated knowledge of pharmaceutical industry laws and regulations, including the Food, Drug, and Cosmetic Act, Anti-Kickback Statute, False Claims Act, and the Foreign Corrupt Practices Act and experience working for 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.

If 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!

Job Summary:

• Based in the US as a hybrid role, advise Global and North America business colleagues in Medical Affairs, Clinical Development, and Global Clinical Operations 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.

Qualifications, Professional Skills, and Preferred Experience

• Law degree and legal experience required.

• 7-9 years post-JD experience providing 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.

• Advanced knowledge of statutes, regulations, and guidance documents applicable to Medical Affairs and Clinical Development activities, 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).

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.

#LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com