Director of Medical Writing

Role Summary

Director of Medical Writing to manage medical writers and author content; develop infrastructure for department maturation and contribute to the overall strategy for medical writing processes according to argenx standards and corporate objectives.

Responsibilities

• Managing focus
  • Manage (80%) medical writers (in-house FTEs, contractors, and external vendors) contributing to MW activities for regulatory documents
  • Author (20%) content and project manage SME contribution for regulatory submissions; ensure content is well-organized, consistent, accurate, and compliant with MW standards, SOPs, style guide, lexicon, templates, and libraries

• Writing focus
  • Manage (20%) medical writers (in-house FTEs, contractors, and external vendors) contributing to MW activities for regulatory documents
  • Author (80%) content and project manage SME contribution for regulatory submissions; ensure content is well-organized, consistent, accurate, and compliant with MW standards, 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, and other documents required for drug development
• Engages relevant SMEs and document owners to develop content for regulatory audiences
• Responsible for inspection-readiness of medical writing activities
• Facilitates standardization of documents using templates, lexicons, and style guide to ensure quality and consistency across programs
• Collaborates with project teams to meet deadlines by providing content development support, research, and editing for each program
• Mentors less experienced medical writers and develops training to support writers and cross-functional teams
• Contributes to development of departmental strategies; participates in corporate objectives, goals, measures, and strategies
• Ensures direct reports execute corporate objectives and manages multifunctional projects with multiple stakeholders
• Ability to work on multiple deliverables simultaneously; responsible for writers assigned to support a project
• Resolves complex issues requiring in-depth evaluation of variable factors; determines methods and procedures for assignments
• May include roles as key technical or subject matter experts providing leadership

Qualifications

• Bachelor’s degree in a scientific or clinical discipline; Ph.D. preferred
• Minimum of 7 years of sponsor-level pharma or biotech clinical/regulatory medical writing experience; CRO experience considered
• Native/bilingual or fluent American English proficiency
• eCTD Module 5 and Module 2 writing experience for global MAAs
• Strong navigation of interrelated disciplines within an organization; solution-focused with leadership experience
• Managed direct reports (contract medical writers considered)
• Understanding of scientific methodology in drug development from protocol design through regulatory submission
• Knowledge of regulatory guidance for medical writing documents; ability to proofread for compliance
• Ability to summarize data, work precisely according to procedures and regulations
• Excellent written and verbal communication; strong multi-tasking and time management; able to work autonomously or in a team
• Proficiency in MS Office

Skills

• Scientific writing and editing
• Regulatory documentation development
• Project management and SME coordination
• Template and style standardization
• Leadership and mentoring
• Cross-functional collaboration

Education

• Bachelor’s degree in a scientific or clinical discipline; Ph.D. preferred

Additional Requirements