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.