Associate Director, Medical Writing

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October 30

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argenx

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Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

1001 - 5000 employees

Founded 2008

🧬 Biotechnology

📋 Description

• Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs • 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 • Manage medical writers (in-house FTEs, contractors, and external vendors) • Collaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors • Executes corporate objectives, goals, measures, and strategies

🎯 Requirements

• Bachelor’s degree in a scientific or clinical discipline or related field required; PhD preferred • Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered • Native/bilingual or fluent American English proficiency • Solution-focused eCTD Module 5 and Module 2 writing experience for global MAAs • Basic understanding of scientific methodology as applied to drug development • Knowledgeable in the regulatory guidances developed for documents authored by medical writing • Ability to proofread documents for compliance with internal and external guidance documents • Excellent time management skills and a proven ability to work on multiple projects

🏖️ Benefits

• Health benefits • Retirement savings plans • Short-term and long-term incentive programs • Comprehensive benefits package