Director of Compliance, Emea
il y a 1 mois
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing a neonatal Fc receptor (FcRn) blocker in the U.S. Japan and the EMEA. The Company is also evaluating that product in multiple serious autoimmune diseases and advancing several earlier stage experimental assets within its therapeutic franchises. argenx currently has offices in Belgium, the United States, Japan, Switzerland, Germany, the UK and France.
We are looking for a Director of Compliance, EMEA to support our fast-growing business in the region, reporting to the VP, Head of Legal & Compliance, EMEA.
Key Accountabilities and Responsibilities:
This person will be a key member of our Compliance and Legal team and the EMEA team. S/he will have a leading role in the design, implementation, monitoring and continual enhancement of an effective compliance program for the EMEA business and will be the primary corporate compliance partner to the EMEA enterprise. The Director of Compliance, EMEA will help maintain a culture of compliance and support adherence to the Company’s Code of Conduct and related rules, policies and procedures. The Director Compliance EMEA will also play a critical role as business partner to help build a successful and sustainable business at a regional and country level. The role will partner closely with colleagues across the Global Compliance and Legal team, in all functions within EMEA, in other regions and with third party partners.
Your primary areas of focus are:
- Work closely with EMEA leadership team to maintain and further develop a strong culture of ethics and compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving.- Manage and evolve the global compliance program in the EMEA and ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with applicable legal and regulatory requirements.- Draft and implement appropriate policies, in collaboration with Compliance and Legal colleagues, to ensure compliance with applicable laws, regulations and codes including that local policies are in place.- Identify training needs within the organization and develop and present training sessions to ensure understanding of compliance issues, as well as related policies and procedures- Plan each quarterly Compliance Committee with the Head of Legal & Compliance EMEA and the General Manager EMEA.- Review and advise on interactions with patients, healthcare professionals, institutions, payors, regulatory agencies and other relevant external stakeholders- Partner with and have oversight over our third-party distributors and other key third party partners to ensure their compliance programs are appropriate.- Closely coordinate risk assessment, investigation, training and related activities.- Assist in planning, implementation and execution of risk-based third-party due diligence process- Execute compliance risk assessments periodically and create and oversee appropriate improvement plans to mitigate risk appropriately, in a tailored and prioritized manner- Support adherence to transparency reporting requirements and reporting obligations- Other duties as assigned
Desired Skills and Experience:
- A minimum of 8 years of biopharmaceutical industry experience in a relevant compliance function, with extensive experience within a commercial stage pharmaceutical or biotech company- Experience with launching new products and/or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals and transparency are all essential- First-rate judgment and business acumen, including understanding of business strategy and operations- Fluent in English and at least one other language- Experience in specialty markets, particularly rare diseases, preferred- Highly analytical; uses data to support decisions; can clearly communicate complex ideas in a simple way to diverse audiences- You are a connector, building relationships and partnering across the organization to achieve the company goals- You excel in a fast-paced, results-driven, highly accountable environment- You are pragmatic, yet creative and innovative and enjoy "rolling up your sleeves" to get it done- You resonate with the values of argenx and you are ready to drive the Company Culture
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