Medical Writing Operations Manager
Remote · Greece
Job Summary
Medical Writing Operations Manager responsible for guiding medical writing vendors and project teams on standard processes for safety narratives and plain language study results summaries (PLSRS), leveraging AI-enabled tools and automation to develop documents. Plan and manage vendor deliverables, governance meetings, forecasting, KPI data collection, and process improvements to enhance operational efficiency. Requires bachelor’s degree in medical-related field or life science (MS/MA +3 years or BS/BA +5 years in medical writing/vendor management), strong project management, independent work style, and excellent communication. Proficiency with Word, PowerPoint, and Excel; knowledge of drug development, ICH, and regulatory guidelines; experience applying responsible AI practices and change management.
Required Qualifications
- Bachelor’s degree in medical-related field or life science
- BS/BA +5 years, MS/MA +3 years of medical writing or vendor management experience in the pharmaceutical or biotech industry
- Experience overseeing multiple medical writing deliverables across multiple project teams and vendors
- Proficient in application of automation and AI in the development of medical writing documents
- Ability to communicate with stakeholders about automation/AI tools; support tool assessments; user acceptance testing; implementation efforts; prompt generation and application
- Understanding of drug development process and regulatory guidelines (ICH)
- Demonstrated ability to deliver within internal and regulatory timelines; monitor milestones; escalate issues
- Knowledge of vendor processes and outsourcing best practices
- Excellent written and verbal communication skills
- Experience with Word, PowerPoint, and Excel
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