Director, Data

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 contribute to the development and execution of the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives. 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 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 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 writing activities Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs Collaborates with project teams to ensure project deadlines are met by providing content development support, research, and editing functions for each program Responsible for inspection-readiness of medical writing activities Mentors less experienced medical writers and develops and implements training to support medical writers and cross-functional teams Directs activities of multifunctional projects and reconciles multiple stakeholder views Responsible for medical writers assigned to support the medical writing activities for a particular project Resolves complex issues in which situational or data analyses require in-depth evaluation of variable factors Bachelors degree in a scientific or clinical discipline or related field required; Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; Native/bilingual or fluent American English proficiency Can provide solutions in creative, effective, and constructive ways eCTD Module 5 and Module 2 writing experience for global MAAs Has managed direct reports (overseeing contract medical writers may be considered) Basic 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 submission Knowledgeable in the regulatory guidances developed for documents authored by medical writing Ability to proofread documents for compliance with internal and external guidance documents Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion Excellent time management skills and a proven ability to work on multiple projects at any given time Must be proficient in MS Office #LI-Remote Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates ("argenx") will handle and protect your personal data. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.