Associate Director, Compliance Business Partner jobs in United States
cer-icon
Apply on Employer Site
company-logo

Vertex · 1 month ago

Associate Director, Compliance Business Partner

Vertex is a transformative biotechnology company that creates new possibilities in medicine to transform diseases and improve people’s lives. The Associate Director, Compliance Business Partner will provide support to the cell and gene, and kidney teams, ensuring effective oversight and guidance on compliance matters while collaborating with various departments to enhance the Global Compliance program.

Computer Software

Responsibilities

Advise Global and North America 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 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

Qualification

Law degreeBiotechnology compliance experienceFDA regulationsMS Office proficiencyProject management skillsAnalytical skillsCommunication skillsTeam playerProblem-solving skillsLeadership skills

Required

Law degree and legal experience required
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)
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

Preferred

3-6 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 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

Benefits

Medical, dental and vision benefits
Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
Educational assistance programs including student loan repayment
A generous commuting subsidy
Matching charitable donations
401(k)

Company

Vertex

twitter
company-logo
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.

Funding

Current Stage
Early Stage
Company data provided by crunchbase