US Compliance Lead - Launch Readiness (Remote)

Zealand Pharma U.S., Inc.; United States; On-site; USD 105,000 - 173,000; Full time

Job summary

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

Remote work is possible with travel; you will design policies, controls, and training to support commercial, medical, market access and patient services teams. You will report to the Head of US Compliance and help implement frameworks for HCP engagement, transparency, and post-launch monitoring across the US organization with strong cross-functional

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.
• Practical knowledge of speaker programs, advisory boards, consulting engagements, fair market value methodologies, and grants, sponsorships and charitable contributions.

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

Skills

Compliance knowledge

Regulatory knowledge

Communication skills

Stakeholder influence

Education

Bachelor's degree

CCEP/CHC or equiv

Job description

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

Remote work is possible with travel; you will design policies, controls, and training to support commercial, medical, market access and patient services teams. You will report to the Head of US Compliance and help implement frameworks for HCP engagement, transparency, and post-launch monitoring across the US organization with strong cross-functional