Full-Time Senior Medical Writer

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

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