Join argenx as Associate Director, Medical Writing and contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. The individual will also develop critical infrastructure for the maturation of the department.
Requirements
- Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug development
- Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience
- Responsible for inspection-readiness of medical writing activities
- Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs
- Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
- Collaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are met
- Responsible for inspection-readiness of medical writing activities
- Responsible for medical writers assigned to support the medical writing activities for a particular project
- Executes corporate objectives, goals, measures, and strategies and begins to inform the development of them
- Capable of working on multiple deliverables simultaneously
Benefits
- Comprehensive benefits package
- Retirement savings plans
- Health benefits
