Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities
Job Summary
Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities.
Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines.
Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, CTT, CST, GCT, and SMT.
Matching Summary
Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities.
Skills & Requirements
Must-have
clinical and safety documents
marketing authorization applications
complex CTD submission documents
Periodic Benefit-Risk Evaluation Report
Risk Management Plans
responses to Health Authorities Queries
Nice-to-have
agile and knowledgeable
stakeholder management skills
work independently and within a team
develop medical regulatory content
Key Requirements
≥8 years of experience in regulatory writing
Advanced degree in life sciences/pharmacy/similar discipline