Associate Director, Medical Writing

Role Summary

Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department. This role contributes to and executes the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives.

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

Qualifications

• Bachelor‚Äôs 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 guidances 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

Skills

• Strong written and verbal communication
• Project management and ability to lead multiple deliverables
• Regulatory documentation and eCTD experience
• Team leadership and vendor management

Education

• Bachelor‚Äôs degree in a scientific or clinical discipline or related field; PhD preferred

Additional Requirements

• Strong preference for individuals located on the East Coast