Senior Medical Writer

Senior Medical Writer

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

For the expansion of our team, argenx is looking for a Senior Medical Writer who will provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions.

This individual will execute the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives.

Key Accountabilities/Responsibilities:

• 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

Desired Skills and Experience:

• 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