Job Overview
Location
United States - Remote
Job Type
Full-time
Category
Product Management
Date Posted
June 25, 2026
Full Job Description
đź“‹ Description
- • Manage a team of medical writers including in-house FTEs, contractors, and external vendors, with primary focus on either 80% management and 20% writing or 20% management and 80% writing based on role alignment
- • Author high-quality regulatory documents including phase 1-4 clinical trial protocols, investigator brochures (IBs), clinical study reports (CSRs), master informed consent forms (ICFs), eCTD modules for INDs and BLAs, briefing documents for scientific advice, pediatric investigation plans (PIPs), orphan drug designations (ODDs), aggregate reports, and requests for information (RFIs)
- • Ensure all medical writing output adheres to argenx medical writing standards, company SOPs, style guide, lexicon, templates, and regulatory requirements
- • Lead the development and standardization of document templates, lexicons, and style guides to ensure consistency and quality across all programs and therapeutic areas
- • Collaborate with subject matter experts (SMEs) across clinical, non-clinical, and regulatory functions to gather, synthesize, and author scientifically accurate and regulatory-appropriate content
- • Maintain inspection-readiness of all medical writing activities and documentation to support regulatory agency inspections and audits
- • Mentor and train junior medical writers and cross-functional teams to build internal capability and ensure adherence to best practices
- • Contribute to the strategic development of the medical writing department and align departmental goals with corporate objectives and business priorities
- • Direct multifunctional project teams, reconcile stakeholder inputs, and ensure timely delivery of regulatory submissions under tight deadlines
- • Resolve complex writing and process challenges requiring in-depth analysis of scientific, regulatory, and operational variables
- • Determine appropriate methodologies and procedures for document development and project execution
- • Serve as a key technical or subject matter expert providing thought leadership in medical writing and regulatory strategy
- • Work autonomously and collaboratively across global teams to support multiple concurrent projects with competing priorities
- • Proofread and edit documents for compliance with internal guidelines and external regulatory guidance documents
- • Maintain proficiency in MS Office tools and apply them effectively to document development, tracking, and collaboration
- • Prioritize and manage multiple high-stakes deliverables simultaneously in a fast-paced, dynamic biotech environment
- • Navigate organizational interdependencies and effectively communicate across disciplines to drive alignment and execution
🎯 Requirements
- • Bachelor’s degree in a scientific or clinical discipline or related field; Ph.D. preferred
- • Minimum of 7 years of sponsor-level pharmaceutical or biotech clinical/regulatory medical writing experience; CRO experience acceptable
- • Native or bilingual fluency in American English
- • Proven experience managing direct reports, including contract medical writers
- • Demonstrated experience authoring eCTD Module 2 and Module 5 content for global marketing authorization applications (MAAs)
- • Deep knowledge of regulatory guidances governing medical writing outputs and inspection readiness standards
🏖️ Benefits
- • Annual base salary range of $212,000.00 - $291,500.00 USD
- • Eligibility to participate in short-term and long-term incentive programs
- • Comprehensive benefits package including retirement savings plans and health benefits
- • Remote work opportunity with no geographic restriction within the United States
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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