Independently write and/or edit/analyse/compile/summarize high-quality clinical and safety documents for timely submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities
Job Summary
Independently write and/or edit/analyse/compile/summarize high-quality clinical and safety documents for timely submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities.
Acts as an Center of Excellence (CoE) leader by disseminating leading-edge knowledge/ best practices, process optimization, and competency in multiple deliverables across various TAs.
Effectively coach, guide and mentor medical writers within the team via structured, focused interactions, and using appropriate strategies, tools and techniques for their development.
Matching Summary
Independently write and/or edit/analyse/compile/summarize high-quality clinical and safety documents for timely submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities.
Skills & Requirements
Must-have
Write clinical and safety documents
Support marketing authorization applications
Develop therapeutic area expertise
Manage end-to-end writing processes
Coach and mentor medical writers
Expert knowledge of global drug registration
Nice-to-have
Disseminate leading-edge knowledge
Process optimization and competency
Integrated and effective communication
Agile and knowledgeable across TAs
Collaborate with global/local teams
Key Requirements
≥12 years of experience in medical regulatory writing
Experience in trainings, mentoring, team management
Advanced degree in life sciences/pharmacy/similar discipline or medical degree