Medical Information Director – Customer Management

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. 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 is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises.

The Director of Customer Management will support the International Region, currently focusing on Europe, the Middle East, and Australia in an above-country Medical Information(MI) delivery model. This role will ensure timely and accurate responses are provided to unsolicited medical and clinical inquiries from healthcare professionals, patients, clinical sites and other healthcare organizations.

Roles and Responsibilities

• Responsible for prompt and accurate responses to medical information requests from internal and external customers through the MI Response Center, email, fax and websites for Europe, Middle East and Australia
• Responsible for ensuring the documentation of the inquiries and responses accurately and completely and are compliant with relevant Standard Operating Procedure (SOP) / Work Instruction and applicable regulatory guidelines
• Ensures that adverse events and product quality complaints are processed in accordance with company SOPs
• Responsible for the creation, review and maintenance of MI documents by ensuring that responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs
• Responsible for managing and training call center team including vendor and argenx personnel
• Ensure the highest degree of quality and medical accuracy for all outputs developed
• Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
• Perform critical analysis and synthesis of internal / external literature related to argenx products and therapeutic areas of focus
• Supports internal teams by providing literature reviews and medical and scientific information related to argenx therapeutic areas
• Exhibits broad knowledge of assigned therapeutics areas, product labelling and regulatory guidance
• Assists in maintenance of relevant knowledge repositories, including medical information responses and publications
• Appropriately liaise with Drug Safety and Quality regarding adverse events and product complaints, ensuring systematic capture and timely reporting
• Complete all work in accordance with regulatory requirements, industry standards, and argenx procedures and policies
• Serves as medial affairs liaison to cross-functional groups for the incorporation of current medical / scientific information into department documents and processes.
• Develop / maintain metrics on key business processes to monitor Medical Information services through call centers

Skills and Competencies

Education, Experience and Qualifications