Aps Level 5/6
2 weeks ago
APS Level 5 - APS Level 6
- $81,372 to $102,765
- Fairbairn ACT, Sydney NSW, Melbourne VIC, Brisbane QLD
MRD also has responsibility for ongoing monitoring of medicines approved for supply in Australia to ensure they continue to maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace.
The division includes:
- Complementary and Over-the-counter Medicines Branch (COMB)
- International Regulatory Branch (IRB)
- Pharmacovigilance and Special Access Branch (PSAB)
- Prescription Medicines Authorisation Branch (PMAB)
- Scientific Evaluation Branch (SEB)
**APS Level 6**
- Undertaking reviews of listed medicines to determine compliance with legislative requirements, including understanding and interpreting complex legislation and independently preparing timely and critically considered recommendations to resolve non-compliances and improve compliance.
- Ensuring evidence of non-compliance is meticulously captured and recorded.
- Recommending legally robust compliance/enforcement actions that are based on risk and a synthesis of evidence/researched information and in-depth knowledge of legislative and administrative frameworks for listed medicines.
- Investigating and monitoring high volumes of potential non-compliance signals, conducting risk assessments to devise control strategies and influence industry behaviour.
- Assessing products at the food/cosmetic-medicine interface and interpreting complex legislation to determine their status as therapeutic goods.
- Autonomously managing multiple work tasks and competing priorities to align with Section goals as they change over time and being accountable for the achievement of key deliverables.
- Liaising, engaging, negotiating and collaborating with internal and external stakeholders to resolve complex and/or sensitive issues.
- Providing strategic advice and technical expertise to guide compliance and enforcement activities.
- Providing effective and influential communication of information to internal and external stakeholders.
- Maintaining databases of listed medicine compliance signals and intelligence data.
**APS Level 5**
- Maintaining databases of listed medicine compliance signals and intelligence data.
- Undertaking reviews of listed medicines to determine compliance with legislative requirements, including understanding and interpreting complex legislation and preparing timely and critically considered recommendations to resolve non-compliances and improve compliance.
- Investigating and monitoring high volumes of potential non-compliance signals, contributing to risk assessments to devise control strategies and influence industry behaviour.
- Prepare correspondence and education products for diverse stakeholders relating to the regulation of low-risk medicines and the outcomes of evaluations, reviews, and assessments.
- Manage multiple work tasks and competing priorities to align with Section goals as they change over time, and being accountable for the achievement of key deliverables; and
- Manage the maintenance of a quality management system, including coordinating the development of SOPs, templates, and training materials.
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