Base: €70,800.00 - €94,400; bonus/equity: not spec...
Hybrid
12+ years medical regulatory writing experience
Expertise in ctd submission documents
Clinical study report (csr) authoring
The role involves independently writing and editing high-quality clinical and safety documents for timely submission to regulatory authorities
Job Summary
The role involves independently writing and editing high-quality clinical and safety documents for timely submission to regulatory authorities.
Candidates will act as a Center of Excellence leader, disseminating leading-edge knowledge and optimizing processes across various therapeutic areas.
The position requires managing end-to-end writing processes for multiple parallel projects while mentoring team members and ensuring compliance with global standards.
Matching Summary
The role involves independently writing and editing high-quality clinical and safety documents for timely submission to regulatory authorities.
Salary
Base: €70,800.00 - €94,400; Bonus/Equity: Not specified; Benefits: Eligible for company employee benefit programs
Skills & Requirements
Must-have
12+ years medical regulatory writing experience
Expertise in CTD submission documents
Clinical Study Report (CSR) authoring
Periodic Benefit-Risk Evaluation Report (PBRER)
Risk Management Plan (RMP) development
Veeva Vault document management system
Nice-to-have
Mentoring and coaching medical writers
Therapeutic area agility across multiple domains
Stakeholder engagement strategy development
Process optimization and best practices
Vendor management for narratives
Key Requirements
Minimum 12 years experience in medical regulatory writing
Advanced degree in life sciences, pharmacy, or medicine
Expert knowledge of global drug registration requirements