Medical Writer - Remote

Overview

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

In Short

• 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.
• 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.

Requirements

• 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.
• 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.

Benefits

• Meaningful work and endless opportunities for growth.
• Once-in-a-career experiences.