Minimum two years pharmaceutical industry experience
Knowledge of clinical drug development process
The role involves providing communication and writing support for China NDA, sNDA, and IND submissions within a clinical delivery team
Job Summary
The role involves providing communication and writing support for China NDA, sNDA, and IND submissions within a clinical delivery team.
Candidates will author complex documents such as Clinical Overviews and Briefing documents for regulatory authorities with senior guidance.
The position requires ensuring alignment of clinical submission documents with proposed prescribing information while contributing to global best practices.
Matching Summary
The role involves providing communication and writing support for China NDA, sNDA, and IND submissions within a clinical delivery team.
Skills & Requirements
Must-have
Bachelor degree in Life Sciences or Pharmacy
Minimum two years pharmaceutical industry experience
Knowledge of clinical drug development process
Expertise in regulatory guidelines for submissions
Ability to author complex clinical documents
Nice-to-have
Experience with project management responsibilities
Strong cross-functional collaboration skills
Proactive and resilient work style
Ability to adapt to changing regulations
Leadership in team excellence building
Key Requirements
BS/BPharm degree in Life Sciences/Pharmacy/Pharmacology
2+ years experience in pharmaceutical/biotech/CRO
Good working knowledge of clinical drug development
Proficiency in regulatory guidelines and communications