Job Description:

• 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

Requirements:

• Bachelor’s degree in a scientific or clinical discipline or related field required; PhD preferred
• Minimum of 5 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 eCTD Module 5 and Module 2 writing experience for global MAAs
• 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
• Knowledgeable in the regulatory guidance developed for documents authored by medical writing
• Ability to proofread documents for compliance with internal and external guidance documents
• Ability to approach issues from various perspectives and accurately summarize data to provide conclusions
• Ability to work precisely according to procedures and regulations
• Excellent written and verbal communication skills
• Ability to prioritize and multi-task successfully in a fast-paced environment
• Ability to work autonomously, as well as collaboratively in a team
• Excellent time management skills and a proven ability to work on multiple projects at any given time
• Must be proficient in MS Office
• Familiarity with Veeva Vault and Please Review preferred
• Familiarity with pharmacovigilance documents preferred

Benefits:

• Comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.