Overview 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.
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 Able to effectively network and partner with internal and external stakeholders and embrace cross-functional working
Strong operational capabilities, eye for detail and commitment to advance and adhere to processes
Able to identify inquirer’s question(s) and formulate and communicate an accurate response
Able to search the published medical literature, evaluate published scientific information and create balanced and informative responses
Understand and demonstrate the importance of providing superior customer service to all clients to support the business
Excellent communication skills: verbal, written and when giving presentations
Able to thrive as part of a team and when working independently
Proven track record of delivering results that meet or exceed targeted objectives
Detailed understanding of industry regulations and practices relating to medical information within Europe
Ensures compliance and inspection/audit readiness
Education, Experience and Qualifications PhD or PharmD or healthcare qualification (PharmD, PhD preferred)
In addition to English, fluency in one or more European languages is preferred
Experience in rare diseases is preferred
5+ years industry experience, working with medical information
Experience managing medical information vendors
Experience in inquiry management systems
Experience in componentized content creation and content management system is preferred
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