Job Overview
Location
United States - Remote
Job Type
Full-time
Category
Data Science
Date Posted
June 25, 2026
Full Job Description
đź“‹ Description
- • Primary author of phase 1-4 clinical protocols, investigator brochures (IBs), clinical study reports (CSRs), master informed consent forms (ICFs), and eCTD modules for INDs and BLAs
- • Develop briefing documents for scientific advice and specialty regulatory documents including Pediatric Investigation Plans (PIPs), Orphan Drug Designations (ODDs), aggregate safety reports, and responses to regulatory information requests (RFIs)
- • Ensure inspection-readiness of all medical writing activities and documentation across global regulatory submissions
- • Lead the standardization of medical writing outputs using company templates, lexicons, and the argenx style guide to maintain consistency and quality across programs
- • Manage a team of in-house medical writers, contractors, and external vendors supporting regulatory document development
- • Collaborate with cross-functional project teams including program leaders, clinical study managers, biostatisticians, and medical directors to meet critical project deadlines
- • Engage subject matter experts (SMEs) to develop accurate, well-organized, and regulatory-appropriate content for complex clinical and nonclinical documents
- • Execute corporate objectives and contribute to the development of medical writing strategy, goals, and performance measures
- • Work on multiple high-priority deliverables simultaneously in a fast-paced, deadline-driven environment
- • Proofread and review documents for compliance with internal policies and external regulatory guidance (e.g., ICH, FDA, EMA)
- • Apply scientific methodology knowledge to understand drug development phases, clinical trial design, and regulatory submission processes
- • Maintain precise adherence to procedural and regulatory requirements in all documentation activities
- • Demonstrate strong written and verbal communication skills to effectively coordinate with internal and external stakeholders
- • Prioritize tasks effectively and manage time efficiently while balancing competing demands across multiple projects
- • Work autonomously and collaboratively within a distributed team structure
- • Utilize MS Office proficiency for document creation, editing, and formatting
- • Familiarity with Veeva Vault and Please Review systems preferred for document management and review workflows
- • Experience with pharmacovigilance documents such as PSURs and DSURs is a preferred asset
- • Support the maturation of the medical writing department through infrastructure development and process improvement initiatives
🎯 Requirements
- • Bachelor’s degree in a scientific or clinical discipline required; PhD preferred
- • Minimum of 5 years of sponsor-level pharmaceutical or biotech clinical/regulatory medical writing experience
- • Native or bilingual fluency in American English
- • Experience with eCTD Module 2 and Module 5 writing for global marketing authorization applications (MAAs)
- • Knowledge of regulatory guidances governing medical writing outputs (e.g., ICH, FDA, EMA)
- • Proficiency in MS Office
🏖️ Benefits
- • Annual base salary range of $164,000.00 - $225,500.00 USD
- • Eligibility for short-term and long-term incentive programs
- • Comprehensive benefits package including retirement savings plans and health benefits
- • Remote work arrangement with strong preference for East Coast residents
Skills & Technologies
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About arGEN-X N.V.
arGEN-X is a global immunology company focused on developing a pipeline of antibody-based therapies for patients suffering from severe autoimmune diseases and cancer. The company leverages its powerful FcRn antagonist technology and broad pipeline to address a range of debilitating conditions. arGEN-X is committed to transforming the standard of care for these diseases and improving patient outcomes. Their approach involves deep scientific understanding of immunology and a dedication to innovation, aiming to deliver breakthrough treatments to those in need. They are driven by a mission to make a meaningful difference in the lives of patients worldwide.
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