Associate Director Principal Medical Writer

Role Summary

Associate Director Principal Medical Writer

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

Responsibilities

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

Qualifications

• Core Experience: Six+ years as medical writer or equivalent specialist role; Proven track record leading multiple clinical documentation projects; Expert in clinical documentation preparation
• Clinical Development Knowledge: 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
• Professional Attributes: Strong attention to detail and deadline management; Excellent organizational and follow-up abilities; Proven ability to work independently and in global teams
• Technical Skills: 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 systems
• Microsoft Office suite
• AI-assisted document authoring and digital technology implementation
• Regulatory writing and Health Authority interactions

Education

• Not specified