Medical Officer Class 3 (MO3) - Clinical Evaluator

About the role

A key Federal Government regulatory health body is seeking experienced Medical Practitioners to join the Clinical Evaluation Section as Medical Officer Class 3 (MO3) Evaluators. This is a high-impact, non-clinical role in which you evaluate complex clinical trial data, pharmacological evidence and submission packages to give evidence-based recommendations that guide the approval and registration of prescription medicines on the national register.

Key responsibilities

• Evaluate complex clinical data and scientific dossiers submitted for prescription medicine approvals and variations
• Formulate clear, defensible clinical assessments and risk-benefit analyses to inform high-level regulatory decisions
• Advise on safety, therapeutic efficacy and quality
• Work with multi-disciplinary scientific teams, external expert committees and regulatory decision-makers within statutory timeframes
• Contribute to continuous improvement of regulatory processes and post-market review of therapeutic products

Required profile

• Mandatory: recognized medical degree (MBBS or equivalent)
• Mandatory: current, unrestricted registration as a Medical Practitioner with AHPRA
• Mandatory: Australian citizenship
• Highly regarded: experience in clinical data evaluation, clinical trials analysis, epidemiological studies or academic research
• Highly regarded: prior experience in a health authority, pharmaceutical clinical governance or regulatory medicine environment
• Highly regarded: solid understanding of the Australian risk-based regulatory framework for therapeutic goods and federal government decision-making