Associate Director, Medical Writing
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Job Description
Associate Director of Medical Writing at argenx developing complex regulatory documents for autoimmune drug development. Collaborating with cross-functional teams to ensure compliance with medical writing standards.
Responsibilities:
- 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.
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