Scientific Compliance Officer
Location: This role will be based in client’s site in Canberra
Branch: The Branch is responsible for the regulation of self-selected medicines. Specifically, regulation of over-the-counter (OTC) registered medicines and listed medicines that are supplied in Australia to provide assurance that these medicines meet appropriate standards of quality, safety and efficacy consistent with their risk and the Therapeutic Goods Act (1989) for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Section: The Section is responsible for:
- Auditing and enforcing the compliance of Listed medicines included in the Australian Register of Therapeutic Goods (ARTG) with regulatory requirements.
- Evaluating scientific evidence of efficacy held by sponsors to support indications and claims for Listed medicines included in the ARTG.
- Reviewing the quality and safety of Listed medicines included in the ARTG.
- Liaising with stakeholders and sponsors in matters relating to the regulation of Listed medicines.
- Undertaking business improvement projects to improve the efficiency and risk-based targeting of compliance activities for Listed medicines.
- Contributing to the education of sponsors about the regulatory requirements for Listed medicines.
Duties of position
Specific duties include:
- Maintaining the section’s compliance databases in relation to listed medicine compliance;
- Researching, analysing and documenting the section’s business processes and policies, including preparing high quality recommendations, plans, reports and guidelines;
- Contributing to developing the section’s quality management system;
- 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 issues;
- Implementing own work plans, including setting tasks and priorities, managing work flows and taking responsibility for the achievement of key outcomes;
Candidates must be able to demonstrate:
A qualification(s) from an Australian tertiary institution or equivalent overseas institution of minimum Bachelors equivalent that included a minimum of 4 subjects from a relevant scientific discipline such as nutrition, dietetics, human biology, chemistry, biochemistry, epidemiology, molecular or cell biology, medical sciences, pharmacy, pharmacology, physiology, zoology, pharmacognosy, or biostatistics.
12 months from commencement with possibility of extension
Past experience in:
- Compliance monitoring, investigation or enforcement;
- Familiarity and use of legislation in a professional setting in Australia;
- Using and working under a quality management systems;
- Supporting teams of professionals in Australian government regulatory, legal or compliance environments.
- Writing and producing formal reports or policy documents within or for Government
- Critically evaluating scientific data (e.g. clinical efficacy, nonclinical or in vitro biological assay data)
- Data analytics and producing reports
- Therapeutic goods production or regulation
Demonstrated capability in:
- Professional written communication for a variety of audiences, in particular Government or its stakeholders
- Researching issues, analysing problems and developing appropriate solutions or strategies;
- Evaluating and critiquing scientific data to a high standard;
- Well-developed written and verbal communication;
- Demonstrated ability to manage competing priorities and tight deadlines;
- Ability to work independently and as part of a team; and
- Enthusiasm for working collaboratively in a busy and dynamic environment.
If interested, please apply directly through the links provided. Alternately, contact Kalpana for more information.
0403 200 666
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