Medical Information Director – Customer Management
vor 24 Stunden
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 ResponsibilitiesResponsible 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 AustraliaResponsible 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 guidelinesEnsures that adverse events and product quality complaints are processed in accordance with company SOPsResponsible for the creation, review and maintenance of MI documents by ensuring that responses are medically and scientifically accurate, timely, balanced, and meet customers’ needsResponsible for managing and training call center team including vendor and argenx personnelEnsure the highest degree of quality and medical accuracy for all outputs developedLiaise with publications and clinical development groups to develop and maintain timely and relevant product expertisePerform critical analysis and synthesis of internal/external literature related to argenx products and therapeutic areas of focusSupports internal teams by providing literature reviews and medical and scientific information related to argenx therapeutic areasExhibits broad knowledge of assigned therapeutics areas, product labelling and regulatory guidanceAssists in maintenance of relevant knowledge repositories, including medical information responses and publicationsAppropriately liaise with Drug Safety and Quality regarding adverse events and product complaints, ensuring systematic capture and timely reportingComplete all work in accordance with regulatory requirements, industry standards, and argenx procedures and policiesServes 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 centersSkills and CompetenciesAble to effectively network and partner with internal and external stakeholders and embrace cross-functional workingStrong operational capabilities, eye for detail and commitment to advance and adhere to processesAble to identify inquirer’s question(s) and formulate and communicate an accurate responseAble to search the published medical literature, evaluate published scientific information and create balanced and informative responsesUnderstand and demonstrate the importance of providing superior customer service to all clients to support the businessExcellent communication skills: verbal, written and when giving presentationsAble to thrive as part of a team and when working independentlyProven track record of delivering results that meet or exceed targeted objectivesDetailed understanding of industry regulations and practices relating to medical information within EuropeEnsures compliance and inspection/audit readinessEducation, Experience and QualificationsPhD or PharmD or healthcare qualification (PharmD, PhD preferred)In addition to English, fluency in one or more European languages is preferredExperience in rare diseases is preferred5+ years industry experience, working with medical informationExperience managing medical information vendorsExperience in inquiry management systemsExperience in componentized content creation and content management system is preferred
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Gümligen, Schweiz Argenx VollzeitJoin argenxAt argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. If you are entrepreneurial, curious and committed to make a difference for patients and thrive on creating solutions for rare autoimmune diseases, then argenx is for you.Next to a competitive salary with extensive benefits, we...
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Senior Medical Director Indication Lead
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Gümligen, Schweiz Argenx VollzeitIt is an exciting time of growth for argenx as we strive to achieve our VISION 2030. Vision 2030 includes the following goals: 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets, including VYVGART and potentially empasiprubart, ARGX-119 and five new molecules in Phase 3 development.The Global...
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Gümligen, Schweiz Argenx VollzeitJoin argenxAt argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. If you are entrepreneurial, curious and committed to make a difference for patients and thrive on creating solutions for rare autoimmune diseases, then argenx is for you.Next to a competitive salary with extensive benefits, we...
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Gümligen, Schweiz Argenx VollzeitJoin argenx At argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. If you are entrepreneurial, curious and committed to make a difference for patients and thrive on creating solutions for rare autoimmune diseases, then argenx is for you.Next to a competitive salary with extensive benefits, we...
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Safety Evidence
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EU Regulatory Lead Director
vor 24 Stunden
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