argenx
1001 - 5000 employees
Founded 2008
🧬 Biotechnology
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.
Director of Medical Writing
🕒 March 27
🇺🇸 United States – Remote
💵 $212k - $291.5k / year
⏰ Full Time
🔴 Lead
✏️ Content Writer
🦅 H1B Visa Sponsor
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argenx
1001 - 5000 employees
Founded 2008
🧬 Biotechnology
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.
📋 Description
• Manage (80%) medical writers, including in-house FTEs, contractors, and external vendors • Author (20%) content and project manage SME contribution for regulatory submissions • Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs • Collaborate with project teams to ensure project deadlines are met • Mentor less experienced medical writers and provides training to support medical writers and cross-functional teams
🎯 Requirements
• Bachelor’s degree in a scientific or clinical discipline or related field required; Ph.D. preferred • Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered • Native/bilingual or fluent American English proficiency • eCTD Module 5 and Module 2 writing experience for global MAAs • Knowledgeable in the regulatory guidances developed for documents authored by medical writing • Ability to proofread documents for compliance with internal and external guidance documents
🏖️ Benefits
• Comprehensive benefits package • Health benefits • Retirement savings plans
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