Medical Information Content & Operations Consultant

at  Argenx

Join 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 offer you the chance to grow and be a part of a team driven by purpose, creativity, innovation and science.
argenx
argenx is a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, we translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.
For the expansion of our EMEA team, argenx is looking for a EMEA Medical Information Content and Operations Lead (contractor).

SKILLS AND COMPETENCIES

• Proven advanced medical writing skills and the ability to communicate complex data or concepts clearly
• Deep knowledge of medical information data sources, their appropriate use, and translation into high-quality responses for Healthcare Professionals
• Resilience and persistence in finalizing highly customized responses where needed
• Experience in managing MI content requests across multiple therapeutic areas
• Lead and manage content projects, leverage internal and external resources and direct content projects through to completion
• Ensures compliance and inspection/audit readiness
• Strong pharma and healthcare system knowledge in EMEA
• Solid understanding of relevant regulations and industry standards related to MI, and pharmaceutical company interactions with Healthcare providers
• Solid understanding of clinical development processes, medical affairs functions, product commercialization, pharmaceutical regulations, and regulatory requirements
• Ability to work collaboratively and effectively together within cross-functional teams and networks
• Demonstrated communication skills, within a multi-cultural and multi-lingual global environment
• Is agile and demonstrates adaptability, comfort with ambiguity, trust-building, and resilience
• Derives energy from operating in a dynamic, complex, fast-moving, and frequently changing business environment
• Demonstrable experience with project management, proactive planning, priority setting, and securing alignment
• Drives toward outcomes
• Ambitious, inquisitive naturally, with demonstrated eagerness to continuously learn, self-improve and develop. This includes being comfortable giving and receiving feedback in a diverse environment.
• Passionate and prepared to lead and contribute to our culture, which is driven by our corporate values of co-creation, innovation, empowerment, excellence, and humility.

EDUCATION, EXPERIENCE

• Advanced scientific or medical degree (PhD, PharmD, or MD)
• A minimum of seven (5) years pharmaceutical experience in MI or equivalent as defined by medical information expertise
• Experience in rare diseases is an advantage
• Experience in neurology, hematology, or immunology is an advantage

PURPOSE OF THE FUNCTION

The argenx commitment to science and patients means that we provide a medical information service embedded in the values of argenx: co-creation, innovation, empowerment, excellence and humility. We strive at all times to deliver a high-quality information service for Healthcare Providers, as we translate clinical science for the real-world clinical setting. Thus, the EMEA Medical Information Content and Operations Lead, reporting to the Director Medical Information EMEA, will apply their expertise and scientific acumen to support all Medical Information (MI) related activities, including the preparation of Q&As and Standard Response Letters, end-to-end inquiry processing, contact center management, business reporting and quality processes. The individual will collaborate closely with cross-functional partners including Medical Affairs, Clinical Development, Regulatory Affairs, Patient Safety and the Global Medical Information Team to drive the development of globally aligned scientific content for internal and external utilization based on different customer needs.

ROLES AND RESPONSIBILITIES

• Identify and summarize relevant scientific content to develop high quality medical information responses in consultation with cross-functional teams (SRLs, Q&As)
• Ensure individual responses to reactive requests for MI are developed in a timely manner to argenx customers
• Manage the life cycle of medical information documents in accordance with emerging data, label updates and other triggers for content revision
• Manage and train first-line medical information providers (Contact Center), ensuring that they have access to the most current information
• Act as product resource for medical and commercial teams
• Driving the evolution of medical information for customer groups and new engagement channels
• Develop analytics capability and insights generation from medical information inquiries
• Develop a quality framework for medical information, including processes, SOPs, training, and audit readiness – affirming the license to operate of the service
• Ensure compliance of the medical information service and responses with applicable regulations and policies
• Collaborate cross-functionally with internal stakeholders
• Initiate process improvement projects to ensure that market needs are met
• Ensure adherence to regulatory and pharmacovigilance requirements and ensure compliance with MI standards and codes of practice
• Develop performance metrics and key performance indicators (KPIs)