Full Job DescriptionJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.argenx is a clinical-stage biopharmaceutical company creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates - tailored from discovery through development to address patient needs.For the expansion of our team, argenx is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department.This individual will contribute to and execute the overall strategy for all medical writing processes to according argenx medical writing standards standards and corporate objectives.Roles and Responsibilities:Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug developmentEngages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audienceResponsible for inspection-readiness of medical writing activitiesFacilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programsManage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documentsCollaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are metResponsible for inspection-readiness of medical writing activitiesResponsible for medical writers assigned to support the medical writing activities for a particular projectExecutes corporate objectives, goals, measures, and strategies and begins to inform the development of themCapable of working on multiple deliverables simultaneouslyDesired Skills and Experience:Bachelor's degree in a scientific or clinical discipline or related field required; PhD preferredMinimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience consideredNative/bilingual or fluent American English proficiencySolution-focusedeCTD Module 5 and Module 2 writing experience for global MAAsBasic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submissionKnowledgeable in the regulatory guidances developed for documents authored by medical writingAbility to proofread documents for compliance with internal and external guidance documentsAbility to approach issues from various perspectives and accurately summarize data to provide conclusionsAbility to work precisely according to procedures and regulationsExcellent written and verbal communication skillsAbility to prioritize