Senior Medical Writer

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Role Description

This role involves providing medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions.

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  Author and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx Medical Writing standards, including style guide, lexicon, templates, and libraries
  


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  Authors content for phase 1-4 protocols, master ICFs, IBs, and CSRs
  


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  Responsible for inspection-readiness of medical writing activities
  


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  Supports the lead writer and project teams to ensure project deadlines are met
  


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  Executes corporate objectives, goals, measures, and strategies
  


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  Capable of working on multiple deliverables simultaneously
  

Qualifications

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  Bachelor’s degree in a scientific or clinical discipline or related field is required; Ph.D. preferred
  


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  Minimum of 3 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
  


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  Native/bilingual or fluent American English proficiency
  


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  Solution-focused
  


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  Experience with Veeva Vault and Please Review
  


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  Experience with implementing lean writing techniques
  


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  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
  


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  Familiarity with pharmacovigilance guidelines and developing aggregate reports
  


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  Ability to work precisely according to procedures and regulations
  


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  Ability to prioritize and multi-task successfully in a fast-paced environment
  


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  Ability to work autonomously, as well as in a team
  


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  Excellent written and verbal communication skills
  


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  Excellent time management skills and a proven ability to work on multiple projects at any given time
  


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  Must be proficient in MS Office
  

Company Description

argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases.

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  Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment.
  


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  Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences.
  


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  Argonauts work in locations around the globe including Belgium, Boston, Japan, and Amsterdam.
  

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