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
Clinical Study Reports writing
CTD submission documents
Periodic Benefit-Risk Evaluation Report
Risk Management Plans
Health Authorities Queries responses
Therapeutic Area expertise
Nice-to-have
Mentoring and coaching skills
Process optimization
Stakeholder engagement strategies
Agile and knowledgeable
Key Requirements
12+ years of experience
Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree