Director of Medical Writing

Roles And Responsibilities

• Manage (80%) medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
• Author (20%) content and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx MW standards, company SOPs, style guide, lexicon, templates, and libraries
• 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
• Collaborates with project teams to ensure project deadlines are met by providing content development support, research, and editing functions for each program
• Responsible for inspection-readiness of medical writing activities
• Mentors less experienced medical writers and develops and implements training to support medical writers and cross-functional teams
• Contributes to the development of departmental strategy(ies)
• Participates in the development of corporate objectives, goals, measures, and strategies
• Ensures direct reports are executing corporate objectives, goals, measures, and strategies
• Directs activities of multifunctional projects and reconciles multiple stakeholder views
• Capable of working on multiple deliverables simultaneously
• Responsible for medical writers assigned to support the medical writing activities for a particular project
• Solves complex issues in which situational or data analyses require in-depth evaluation of variable factors
• Determines methods and procedures for assignments

Desired Skills And Experience

• Bachelor’s degree in a scientific or clinical discipline or related field required; Ph.D. preferred
• Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
• Native/bilingual or fluent American English proficiency
• Can provide solutions in creative, effective, and constructive ways
• ECTD Module 5 and Module 2 writing experience for global MAAs
• Understands the interrelationships of various disciplines within the organization and can effectively navigate
• Solution-focused and experience leading teams
• Managed direct reports (overseeing contract medical writers may be considered)
• 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
• Able to proofread documents for compliance with internal and external guidance documents
• To approach issues from various perspectives and accurately summarize data to draw a conclusion
• 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
• Proficient in MS Office