Associate Director, Medical Writing

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.