Aps5 Compliance Officer

3 days ago

Canberra, Australia Chandler Macleod Full time

As one of the Australia’s largest providers of human resources solutions, Chandler Macleod has a proven track record of unleashing potential in people and companies. For over 40 years Chandler Macleod’s recruitment business has connected leading-edge projects and employers with outstanding business professionals.

Our Federal Government client is seeking to engage an APS5 Compliance Officer on a contract for 3 months with potential extension.

**Position Overview**

**Duties & Responsibilities**:
Specific duties include:

- Maintaining the section’s compliance databases in relation to listed medicine compliance leads and intelligence data
- Triaging and risk assessing signals of potential breaches of therapeutic goods legislation
- Exercise sound scientific judgement in recommending risk-based compliance enforcement actions to decision makers in line with section, branch and organisation plans and policies, in the context of a complex and changing environment
- Prepare correspondence and education products for diverse stakeholders relating to the regulation of low-risk medicines and the outcomes of evaluations, reviews and assessments
- Undertake research, analysis and administrative coordination for compliance projects and regulatory reform implementation
- Liaising, engaging, negotiating and collaborating with internal and external stakeholders, including collaboration to resolve complex and/or sensitive issues;
- Contributing to continuous improvement and regulatory reform activities that are consistent with the strategic objectives of the Agency and the Government

**Desirable**:

- Knowledge of and experience in the regulation of therapeutic goods;
- Experience in scientific evaluation of medicine safety, quality or efficacy;
- Understanding of the design and interpretation of clinical trials (e.g. knowledge of CONSORT and Good Clinical Practice guidelines);
- Understanding of international guidelines (e.g. OECD and ICH) to assess safety (e.g. animal toxicology studies) and quality (e.g. manufacturing stability) data.
- Understanding of data manipulation and using software (including Qlik) to interrogate and report on data

**Mandatory Requirements**:

- A relevant qualification in toxicology, chemistry, epidemiology, biochemistry, molecular or cell biology, medical sciences, pharmacology, pharmacognosy, naturopathy, health sciences, biostatistics, law or any other relevant discipline from an Australian tertiary institution or comparable overseas qualification

**Eligibility Requirements**:

- Australian Citizenship is essential

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