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.
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
Authors content for phase 1-4 protocols, master ICFs, IBs, and CSRs
Responsible for inspection-readiness of medical writing activities
Supports the lead writer and project teams to ensure project deadlines are met
Executes corporate objectives, goals, measures, and strategies
Capable of working on multiple deliverables simultaneously
Qualifications
Bachelor’s degree in a scientific or clinical discipline or related field is required; Ph.D. preferred
Minimum of 3 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
Experience with Veeva Vault and Please Review
Experience with implementing lean writing techniques
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
Familiarity with pharmacovigilance guidelines and developing aggregate reports
Ability to work precisely according to procedures and regulations
Ability to prioritize and multi-task successfully in a fast-paced environment
Ability to work autonomously, as well as in a team
Excellent written and verbal communication skills
Excellent time management skills and a proven ability to work on multiple projects at any given time
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.
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.
Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences.
Argonauts work in locations around the globe including Belgium, Boston, Japan, and Amsterdam.
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