The role is responsible for the operational implementation and maintenance of the Pharmacovigilance Quality Management System (QMS) and oversight of third-party contractual obligations. Key duties include managing GPS procedural documents, driving continuous improvement, and coordinating audit and inspection readiness.
argenx
20 Remote Job Openings at argenx
The Clinical Operations Development Lead co-leads the Clinical Development Team to oversee clinical activities and execute the Clinical Development Plan for specific therapeutic indications. This includes managing budgets, timelines, and resource requirements while ensuring trial execution aligns with quality standards and regulatory requirements.
The Commercial Lead will drive commercial excellence across a diverse portfolio of distributor-led and partner markets, ensuring successful commercialization of VYVGART and future pipeline assets. This role involves strategic leadership, partner governance, and execution oversight to maximize patient impact and sustainable business growth.
The Territory Business Manager drives demand generation for the Neurology Franchise by engaging healthcare professionals, academic institutions, and specialty pharmacies. They are responsible for developing local market strategies and meeting quarterly sales objectives within their assigned geography.
The MSL serves as a scientific expert engaging with Key Opinion Leaders to support medical strategy and patient care. They are responsible for identifying clinical trial sites, gathering medical insights, and providing scientific education on immunology products.
The Territory Business Manager drives demand generation for the Neurology Franchise by engaging healthcare professionals and specialty pharmacy providers. The role focuses on meeting quarterly sales objectives and developing local market strategies within the assigned geography.
The MSL serves as a scientific expert engaging with Key Opinion Leaders to support argenx's immunology pipeline and clinical trials. They are responsible for generating medical insights, delivering scientific education, and identifying potential clinical research sites within their territory.
The MSL serves as a scientific expert engaging with Key Opinion Leaders to support medical strategy and patient care. They are responsible for identifying clinical trial sites, gathering medical insights, and delivering scientific education on autoimmune diseases.
Medical Science Liaison, Multi-Specialty (Northeast or Southeast)
argenx
·
Full Time
·
a month ago
argenx
The MSL serves as a scientific expert engaging with Key Opinion Leaders to support medical affairs strategy and patient care. They are responsible for identifying clinical trial sites, gathering medical insights, and delivering scientific education on autoimmune diseases.
Develop and implement regional market access strategies in Germany to optimize reimbursement and pricing for the product portfolio. Act as the primary interface between the company and regional stakeholders, including health insurance funds and hospital decision-makers.
The Associate Director will define the US insights strategy and learning agenda for the rheumatology portfolio to shape decision-making. This role involves synthesizing data from multiple sources to provide actionable recommendations for market development and go-to-market strategies.
Head of U.S. Regulatory Advertising & Promotion and Strategic Commercialization
argenx
·
Full Time
·
a month ago
argenx
Define and execute the U.S. regulatory strategy for promotional materials and serve as the primary authority for FDA advertising and promotion compliance. Lead the regulatory oversight of HCP and consumer materials while evolving capabilities through AI and digital automation.
Lead the strategy, design, and execution of the US Patient Assistance Program to ensure patients facing financial barriers can access therapy. Oversee end-to-end operations, vendor performance, and compliance across current and future product indications.
Lead the development and execution of global commercialization and launch strategies for late-stage clinical programs in rheumatology. Coordinate cross-functional teams to define product strategy, branding, and market activation to maximize commercial success.
The MSL serves as a scientific expert engaging with Key Opinion Leaders to support medical strategy and identify unmet medical needs. They are responsible for identifying clinical trial sites, supporting research execution, and disseminating scientific data within the organization.
This role involves managing medical writers, including in-house staff and vendors, while also authoring content for regulatory submissions to ensure accuracy and compliance with company standards. The individual will contribute to the development and execution of the overall strategy for all medical writing processes.
The Medical Safety Lead will provide strategic medical safety leadership, acting as the primary contact for all patient safety aspects, and will be accountable for defining and driving the strategy for communicating safety information across the product lifecycle. Responsibilities include offering expert medical safety contribution, ensuring ownership of safety activities, and leading safety data assessment to support informed decision-making.
The Senior Medical Writer will provide medical writing support for developing complex clinical, nonclinical, and safety documents required for regulatory submissions. This role involves authoring and project managing content for various documents like protocols, ICFs, IBs, and CSRs, ensuring compliance with company standards.
The Associate Director of Medical Writing will primarily author complex clinical, nonclinical, and safety documents required for regulatory submissions, while also developing critical infrastructure for departmental maturation. This role involves executing the overall strategy for medical writing processes to align with company standards and objectives.
The Legal Counsel Germany will serve as a business partner and facilitator for business activities, contributing to product launches and commercialization. They will provide legal guidance across various areas including medical, commercial, and regulatory matters.