Job Description

Key Responsibilities

Clinical Development & Trial Execution

Lead and support Phase I–III clinical studies from study design through completion

Provide scientific and operational oversight of clinical trials conducted with external research partners

Contribute to protocol development, study strategy, and clinical development plans

Ensure trials are conducted in accordance with ICH-GCP, regulatory requirements, and company SOPs

Clinical Writing (Hands-on)

Author, review, and finalize key clinical documents, including:

o

Clinical study protocols and amendments

o

Clinical Study Reports (CSRs)

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Investigator’s Brochures (IBs)

o

Informed Consent Forms (ICFs)

o

Clinical sections of regulatory submissions and responses

Ensure accuracy, clarity, and consistency across...

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