Job Description
Job Summary
Provide clinical, medical, and regulatory support for ongoing and upcoming studies, including contributing to the development of clinical protocols and pre-clinical study plans, and managing responses to health authority (HA) queries
Key Responsibilities
Support clinical, medical, and regulatory activities across Phase I–IV studies
Help design and review clinical protocols and study plans
Prepare and review regulatory documents (IB, CO, NCO, submissions, SEC/IND packages)
Analyze clinical and preclinical data and respond to health authority queries
Review study reports, publications, and ensure compliance with regulatory standards
Monitor ongoing clinical trials for safety, efficacy, eligibility, and data accuracy
Collaborate with KOLs, investigators, CROs, and medical writers
Support training, safety reporting, and site initiation activities
Provide input for SOP development and cross-functio...