Manager/Sr. Manager, US Compliance

Zealand Pharma U.S., Inc.; Cambridge (MA); On-site; USD 105,000 - 173,000; Full time

Job summary

Zealand Pharma U.S., Inc. seeks a Manager/Senior Manager to build the US compliance program ahead of first commercial launch.

The role is remote in the United States with some travel, reporting to the Head of US Compliance, and will shape policies, controls, and training for commercial, medical, market access, and patient services teams. You will design frameworks for ongoing compliance, oversee Open Payments and registration requirements, and collaborate with Finance to ensure proper

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; more is encouraged and level will be determined by background.
• Demonstrated experience supporting a US product launch in a compliance capacity, including pre-launch preparation.
• Knowledge of speaker programs, advisory boards, consulting engagements, fair market value methodologies, grants, sponsorships and charitable contributions.
• Working knowledge of AKS, False Claims Act, Sunshine Act, Open Payments, FDA promotional requirements, PhRMA Code and OIG Guidance.
• Experience in a smaller or scaling organization with excellent written and verbal communication and ability to influence senior stakeholders.

Responsibilities

• Help build the foundational US healthcare compliance program, including code of conduct, policies, SOPs, training curriculum and supporting controls.
• Prepare launch readiness across the commercial model, assessing planned activities against regulatory requirements.
• Develop frameworks for HCP engagement, including advisory boards and speaker programs.
• Own US-specific transparency requirements in collaboration with Finance, including Open Payments obligations.
• Design monitoring and risk assessment processes to support post-launch program effectiveness.
• Deliver training and act as a trusted advisor to business partners across the US organization.

Skills

Compliance knowledge

US product launch

Communication skills

Education

Bachelor’s degree

CCEP/CHC certification

Job description

Manager / Senior Manager, US Compliance

Manager / Senior Manager, US Compliance 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.

Your new position 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 design policies, controls and training that do not yet exist, and prepare the frameworks that commercial, medical, market access and patient services colleagues will rely on once activities go live. This is a builder’s role rather than a maintenance one, offering breadth and visibility that is rare in larger, more established organizations. The position can be performed remotely from the United States, with some travel expected.

We offer exciting responsibilities

• 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

Your profile You are pragmatic, curious and energized by building rather than inheriting. You are comfortable in an environment where the answer is often “we haven’t decided yet,” and you enjoy being close to the business, offering clear risk-based guidance rather than binary answers. Strong judgment, discretion and the ability to build trust across functions matter more here than depth in any single sub-discipline. You work well independently in a remote setting and collaborate easily across US and Danish colleagues.

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

Salary Range

• Manager: $105K - $145K
• Senior Manager: $126K - $173K

Your new team

You will join the US Compliance function within Legal, reporting directly to the Head of US Compliance. The team supports Zealand Pharma’s growing US organization, based in Cambridge, Massachusetts, and works closely with global colleagues at headquarters in Copenhagen, Denmark.

Let’s bond and be bold

We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture. Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let’s bond and be bold.

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

About Zealand Pharma A/S

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. Learn more at www.zealandpharma.com.

Since our founding in 1998, Zealand Pharma has built a core expertise in the discovery, design, and development of therapeutic peptides. This expertise has led to an R&D pipeline of innovative investigational candidates designed to address a broad range of disease areas.

We have four therapeutic focus areas: obesity, rare diseases, chronic inflammation, and type 1 diabetes.

In obesity, our peptide capabilities place us in a unique position to address a vast global health challenge and positively impact hundreds of millions of lives.

Within rare diseases, we have a long-standing commitment to deliver new treatments to patients living with congenital hyperinsulinism and short bowel syndrome.

For chronic inflammatory diseases, we are progressing peptide programs focused on high-profile targets shown to be difficult to address with small molecules and antibodies.

For type 1 diabetes, we aspire to change the management of this disease.

Our strategy is to pursue global co-development and commercialization partnerships that complement and extend our capabilities across the value chain to deliver new peptide therapies to people who need them.