The Role

& Department

As an EU Compliance Director, you will be in the Global Compliance & Risk function and responsible for compliance advisory and program management in EU region. You will report to Global Compliance Program & EU Compliance Lead, Senior Director. The EU Compliance Director strategically partners with and advises the business, including working closely with R&D teams, EU Medical Affairs, Alliance Management and key enabling functions (e.g. Finance, Legal, HR, IT&D) in EU.

EU Compliance Director ensures establishment of compliance program frameworks and advisory supporting Genmab ethical business practices across functions and compliance with all applicable healthcare-related* laws, codes, rules, regulations and practices applicable to its operations in Europe (*including without limit those applicable to the research, development and launch & commercialization preparedness as to Genmab’s therapies and products in EU). The EU Compliance Director plays a pivotal role in fostering and promoting a culture of ethics and integrity across Genmab’s organization.

Key responsibilities include:

• Acts as a designated subject matter expert/centre of excellence and primary point of contact to the business by providing strategic advisory in relation to interaction with Healthcare Professionals (HCPs), government officials, payers, patients, patient organizations and other healthcare stakeholders in EU.
• Together with Global Compliance Program & EU Compliance Lead, Senior Director and other key functions, you will contribute to the design, implementation, maintenance and monitoring of the core elements in the Global Compliance program in the EU. The activities include, amongst others, the development, implementation and monitoring of healthcare compliance-related systems and processes such as the third-party risk management, EU compliance policies management, cross-border HCP engagement & fair market value process, transparency reporting, speak up & investigation management, company-wide and business-specific policies, procedures and practices and training programs.
• Regularly reviews the EU compliance program and partners routinely with key business and functional leads to recommend appropriate modifications and enhancements, including advising leadership (e.g. site leadership team) of potential compliance risk areas.
• Conducts compliance risk assessments of existing and new business areas as required; maintain and manage R&D compliance risk register which includes but is not limited to maintaining and tracking of up-to-date trend analysis and root cause analysis, implementing controls/improvements, monitoring plans, etc.
• Acts as the primary compliance reviewer in the global third party due diligence tool (VANTAGE) and raise issues or red flags to the relevant Compliance Lead as necessary.
• Manages and conducts regular compliance trainings (including EU new hire training); provide tailored trainings / workshops / presentations to educate and inform the business, local leadership teams and other staff members on matters related to the compliance program as well as relevant healthcare industry regulations and compliance developments.
• Co-drives compliance governance and agenda with Global Compliance Program & EU Compliance Lead, Senior Director, through participating and/or presenting at local/site leadership meetings.
• Prepares reports / dashboards related to healthcare compliance program and activities in the EU on a regular or at the request of the Global Compliance Program & EU Compliance Lead, Senior Director.
• Monitors developments in EU laws, regulations and life science industry practices in relation to interactions with HCPs, government officials, payers, patients, patient organizations and other healthcare stakeholders; and keep up-to-date country requirements and fair market value rates for countries in EU.

Requirements:

• EU bachelor’s degree (preferably in Business, Finance or Law). Advanced degree and/or EU Healthcare Compliance certification or equivalent is preferred
• At least 8 years of direct experience in healthcare compliance or similar role supporting the following areas: anti-bribery and anti-corruption, HCP/HCO/GO regulations and practices, transfer of value/transparency reporting/FMV processes, research & development compliance, third party due diligence processes, promotional activities, speaker programs, advisory boards, sponsorships and grants and donations. Experience regarding pharmaceutical product launches and compliance program implementation and/or oncology business support will be a plus.
• Expert knowledge of prevailing EU healthcare compliance standards and practices, including but not limited to IFPMA and EFPIA code requirements and standards.
• Ability to work effectively in a senior compliance role in global cross-cultural and cross-functional teams. Experience working in a diverse office culture, good understanding of different cultures and able to articulate complex matters in a practical and simple manner to internal business stakeholders.
• Strong communication, problem solving, highly analytical, high risk awareness and risk management skills, good presentation skills
• Fluent English speaking and writing skills required. Spoken Dutch and/or Danish language will be a plus but not a requirement.
• Occasional travel within EU and/or International [15-20%] may be required.

This role can be located in Copenhagen, Denmark; or Utrecht, the Netherlands, and is hybrid. ​​

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.