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 focuso 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 librariesORWriting focuso 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 librariesANDPrimary 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 programsCollaborates with project teams to ensure project deadlines are met by providing content development support, research, and editing functions for each programResponsible for inspection-readiness of medical writing activitiesMentors less experienced medical writers and develops and implements training to support medical writers and cross-functional teamsContributes to the development of departmental strategy(ies)Participates in the development of corporate objectives, goals, measures, and strategiesEnsures direct reports are executing corporate objectives, goals, measures, and strategiesDirects activities of multifunctional projects and reconciles multiple stakeholder viewsCapable of working on multiple deliverables simultaneouslyResponsible for medical writers assigned to support the medical writing activities for a particular projectResolves complex issues in which situational or data analyses require in-depth evaluation of variable factorsDetermines methods and procedures for assignmentsMay include roles that are key technical or subject matter experts providing professional or thought leadershipLooks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to achieving objectivesDesired Skills and Experience:Bachelor’s degree in a scientific or clinical discipline or related field required; Ph.D. preferredMinimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience consideredNative/bilingual or fluent American English proficiencyCan provide solutions in creative, effective, and constructive wayseCTD Module 5 and Module 2 writing experience for global MAAsUnderstands the interrelationships of various disciplines within the organization and can effectively navigateSolution-focused and experience leading teamsHas 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 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 draw a conclusionAbility to work precisely according to procedures and regulationsExcellent written and verbal communication skillsAbility to prioritize and multi-task successfully in a fast-paced environmentAbility to work autonomously, as well as collaboratively in a teamExcellent time management skills and a proven ability to work on multiple projects at any given timeMust be proficient in MS Office#LI-Remote‎ For applicants in the United States: The annual base salary hiring range for this position is $212,000.00 - $291,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.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.At argenx, all applicants are welcomed in an inclusive environment. 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. argenx is proud to be an equal opportunity employer.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 have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com.If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.

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