[Hiring] Manager/Sr. Manager, US Compliance @Zealand Pharma

Role Description

Does it excite you to build a US compliance program from the ground up ahead of first commercial launch, and do you have experience taking a pharmaceutical or biotech organization through US launch readiness? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

As Manager / Senior Manager, US Compliance, you will join a growing US organization ahead of commercialization and help lay the compliance foundation on which the future US business will operate. Reporting to the Head of US Compliance, you will:

• Help build the foundational US healthcare compliance program, including the code of conduct, policies, SOPs, training curriculum and supporting controls.
• Prepare launch readiness across the commercial model, assessing planned activities against the Anti-Kickback Statute, the False Claims Act, FDA advertising and promotion requirements, the PhRMA Code and OIG Compliance Program Guidance.
• Develop frameworks and guidance for future HCP engagement, including advisory boards, speaker programs, consulting arrangements, fair market value and needs assessment processes.
• Own the US-specific requirements within transparency and aggregate spend compliance in partnership with Finance, including Open Payments obligations and future state sales representative registration, licensing and reporting requirements.
• Design the monitoring and risk assessment processes that will support the program post-launch, including the underlying data, analytics and metrics used to measure and report on compliance program effectiveness.
• Deliver training and serve as a trusted day-to-day advisor to business partners across the US organization.

Qualifications

• Bachelor’s degree required; a compliance certification such as CCEP, CHC or equivalent is highly desirable.
• At least 3-5 years of compliance experience within the pharmaceutical or biotechnology industry; candidates with more extensive experience are encouraged to apply, and level will be determined based on background.
• Demonstrated experience supporting a US product launch in a compliance capacity, including pre-launch preparation.
• Practical knowledge of speaker programs, advisory boards, consulting engagements, fair market value methodologies, and grants, sponsorships and charitable contributions.
• Working knowledge of the Anti-Kickback Statute, the False Claims Act, the Sunshine Act and Open Payments, FDA promotional requirements, the PhRMA Code and OIG Compliance Program Guidance.
• Experience in a smaller or scaling organization, with excellent written and verbal communication skills and the ability to influence senior stakeholders.

Requirements

• Strong judgment, discretion and the ability to build trust across functions.
• Work well independently in a remote setting and collaborate easily across US and Danish colleagues.

Benefits

• Salary Range: Manager: $105K - $145K; Senior Manager: $126K - $173K.

Company Description

Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.

To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Cambridge, Massachusetts.