Associate Director Principal Medical Writer

Role Summary

Associate Director Principal Medical Writer

Responsibilities

• Create high-quality regulatory-compliant clinical documents supporting product life cycle
• Ensure timely delivery while maintaining compliance with standards
• Lead implementation of new digital technologies and AI solutions
• Drive process improvements for efficiency gains
• Prepare registration dossiers and Health Authority responses
• Monitor and implement regulatory documentation requirements
• Lead cross-functional initiatives as Subject Matter Expert
• Drive change management within writing teams
• Update relevant stakeholders on project progress and needs
• Maintain accurate information in planning, tracking, and reporting tools
• Ensure consistent communication across ClinDoc functions
• Mentor junior writers and review contract work
• Develop training programs and documentation standards
• Build effective relationships with stakeholders and partners

Qualifications

• Six+ years as medical writer or equivalent specialist role
• Proven track record leading multiple clinical documentation projects
• Expert in clinical documentation preparation
• Demonstrated expertise in clinical development processes
• Strong understanding of clinical study methodology and basic statistics
• Knowledge of regulatory environment
• Proficient in document management systems and authoring platforms
• Strong attention to detail and deadline management
• Excellent organizational and follow-up abilities
• Proven ability to work independently and in global teams
• Expertise in electronic document management and Microsoft Office
• Proven experience in implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions

Skills

• Electronic document management
• Microsoft Office
• AI-assisted document authoring solutions
• Regulatory writing and clinical documentation

Education

Additional Requirements

• Location: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings