Manager, US Medical Review

📋 Description

• • Join argenx, a dynamic biotech company committed to transforming immunology and delivering life-changing medicines to autoimmune patients. We are on a path of significant expansion, driven by a robust pipeline and our first-in-class neonatal Fc receptor blocker, VYVGART, which is already approved for gMG and holds potential for numerous other severe autoimmune diseases.
• • As the Manager, US Medical Promotional Review, you will play a pivotal role within the US Materials Review Committee (MRC) and/or the US Medical Materials Committee (MMRC), operating as a key member of the Medical Affairs team.
• • This role reports to the Head of USMA Integrated Medical Capabilities and is an integral part of the broader Medical Review Community, contributing to the accurate and consistent communication of product and therapeutic area information.
• • Your primary responsibility will be the medical review of promotional and Medical Affairs materials, ensuring all communications are scientifically accurate, truthful, not misleading, and supported by appropriate references.
• • You will provide solutions-oriented feedback, fostering collaborative relationships with cross-functional teams including Marketing, Legal, and Regulatory, as well as other members of the Medical Review Community, such as the Associate Director (AD) of US Medical Promotional Review.
• • A crucial aspect of this role involves supporting the Reference Library and associated operational processes, ensuring efficient management of critical information resources.
• • You will be responsible for maintaining ongoing, clear communication across the entire Medical Review Community and the MRC Review Committee, facilitating a cohesive and informed review process.
• • This position requires a deep commitment to maintaining up-to-date scientific knowledge. This includes staying abreast of product labeling, relevant therapeutic areas, the latest medical literature, current treatment guidelines, and competitor activities through continuous engagement with internal and external data sources, training programs, and industry conferences.
• • You will be expected to fully comply with all argenx policies, as well as all applicable laws, regulations, and ethical standards, making decisions that align strictly with established guidelines and company policies.
• • The role demands the ability to effectively partner with the Medical Review Community and embrace a cross-functional working environment, recognizing the importance of collaboration in achieving shared goals.
• • Strong operational capabilities are essential, characterized by meticulous attention to detail and a steadfast commitment to advancing and adhering to established processes for material review and approval.
• • You will leverage your ability to critically evaluate scientific literature, interpret complex data, write with clarity and precision, and articulate information effectively to diverse audiences.
• • Negotiation skills will be vital as you engage with counterparts from various cross-functional areas to ensure the highest standards of medical accuracy and compliance.
• • As a strong team player, you will contribute a positive attitude and demonstrate flexibility in prioritizing tasks within a fast-paced and dynamic environment, ensuring project timelines are met without compromising quality.
• • You will be accountable for ensuring the highest degree of quality and medical accuracy in all outputs developed, upholding argenx's commitment to scientific integrity.
• • All work must be completed in strict accordance with regulatory requirements, industry standards, and argenx policies, reflecting a dedication to ethical and compliant practices.
• • This role offers the opportunity to contribute significantly to the successful launch and lifecycle management of innovative therapies, directly impacting patient access to critical treatments.
• • You will be a guardian of scientific accuracy and compliance, ensuring that all external communications reflect the cutting-edge science and patient-centric mission of argenx.
• • The position requires proactive engagement with evolving regulatory landscapes and industry best practices to ensure continuous improvement in medical review processes.
• • You will contribute to the development and refinement of internal SOPs and guidelines related to medical review, enhancing the efficiency and effectiveness of the team.
• • This role is ideal for a scientifically rigorous individual who thrives in a collaborative, high-impact environment and is passionate about making a difference in the lives of patients with autoimmune diseases.