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-functional project execution
- Present scientific data to internal and external stakeholders

📌 Manager - Medical Monitor (India)
🏢 Talental Consultings
📍 India