This team manages the end-to-end lifecycle of Clinical Study Reports to support global drug registration and approval processes
Job Summary
This team manages the end-to-end lifecycle of Clinical Study Reports to support global drug registration and approval processes.
The role requires leading coordination, quality control, and submission activities while ensuring compliance with international regulatory standards like ICH E3.
Candidates will serve as subject matter experts, authoring SOPs and facilitating cross-departmental collaboration to optimize CSR workflows.
Matching Summary
This team manages the end-to-end lifecycle of Clinical Study Reports to support global drug registration and approval processes.
Skills & Requirements
Must-have
In-depth knowledge of drug development process
Independent delivery of all phases CSR
Great CSR timeline management capability
Coordination in highly regulated environment
Understanding of regulatory filing guidelines
Nice-to-have
Experience mentoring others effectively
Troubleshoot technical issues independently
Preferred skills in electronic submissions
Fluency regarding dossier presentation order
Key Requirements
Master's or bachelor's degree in life sciences
Proficiency in English and Chinese language preferred
Demonstrated experience working in a customer service environment