Associate Director Ethics & Compliance

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

Purpose of the Function The Associate Director Ethics & Compliance is a key member of our globally operating Ethics & Compliance team who will mainly support our commercial and medical operations in the European Region incl. Australia and Canada. This is an opportunity to further develop a best-in-class compliance program by role modelling the business partnership with all functions within argenx.

In this role you will be a key advisor across the product life cycle and an enabler of successful product launches and commercialisation at a regional and country level. The responsibilities will include advising on key projects and day to day activities, developing policies or other written standards and training materials incl. providing trainings in the countries, supporting with auditing and performing monitoring activities and other general compliance activities and specifically fostering the strong ethical culture of argenx.

• Advise the business functions regarding compliance and continue to evolve the Global Ethics & Compliance program in the region and ensure that it is consistent with the values and principles of the organisation, fit for purpose and complies with applicable legal and regulatory requirements.
• Serving as an advisor to regional and local commercial and medical teams to provide compliance-based input and direction across product portfolio.
• Review and advise on interactions with patients/Patient Organisations, healthcare professionals, institutions, payors, regulatory agencies and other external stakeholders.
• Draft and implement appropriate policies, procedures and guidance, in collaboration with the Head of Ethics & Compliance DM & Germany, Legal and other Ethics & Compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in the respective countries and region (excluding cGMP, cGCP and other GxP guidelines).
• Support adherence to transparency reporting requirements and reporting obligations where required.
• Conduct or assist in compliance-related investigations and other allegations of misconduct, as required.
• Prepare and deliver Ethics & Compliance training and education to the organisation incl. field-based employees to ensure understanding of employee responsibilities and overall Ethics & Compliance framework, as well as related policies and procedures.
• Foster the strong ethical culture of argenx.
• Other duties as assigned.

• Regional experience with launching new products and/or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals and transparency are all essential.
• Team-player, able to work well with others and communicate with cross-functional colleagues and senior leadership.
• Strong interpersonal and oral and written communication skills; a collaborator who communicates in an open, clear, complete, timely and consistent manner in a multi-cultural and multi-lingual global environment.
• Shows flexibility and is open to…