Director of Medical Writing

*Join 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 a Director of Medical Writing to manage medical writers and author content. This individual will also develop critical infrastructure for the maturation of the department. This individual will contribute to the development and execution of the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives. **Roles and Responsibilities:** Managing focus o Manage (80%) medical writers (in\-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents o Author (20%) content and project manage SME contribution to develop content for regulatory submissions that is well\-organized, consistent, accurate, and compliant with argenx MW standards, company SOPs, style guide, lexicon, templates, and libraries OR Writing focus o Manage (20%) medical writers (in\-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents o Author (80%) content and project manage SME contribution to develop content for regulatory submissions that is well\-organized, consistent, accurate, and compliant with argenx MW standards, company SOPs, style guide, lexicon, templates, and libraries AND * 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 development * Engages relevant SMEs and document owners to develop content that is well\-organized, consistent, accurate, and appropriate for a regulatory audience * Responsible for inspection\-readiness of medical