Job Details
  • Reference392975A_1653460009
  • LocationCanberra
  • Job TypeContract
  • Postedabout 1 month ago
  • ConsultantLeanne Porter

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 a APS6 Scientific Evaluator on a contract for 6 months with potential extension.

About the Role:

The department is responsible for the regulation of over-the-counter medicines as well as complementary medicines, which include traditional and herbal medicines, vitamin and mineral supplements, that are supplied in Australia to provide assurance that these medicines meet appropriate standards of quality, safety and efficacy consistent with their risk.

The department undertakes market authorisation and compliance activities including:

  • Post market compliance reviews of low risk medicines;
  • Pre-market evaluations of registered over-the-counter and complementary medicines;
  • Assessment of new substances for use in listed medicines; and
  • Maintaining the listed medicines application portal for low risk listed medicines.

The department fulfils its regulatory role by collaborating with other regulators, stakeholders, consumers and health care professionals.

The other department is responsible for:

  • Evaluating the quality, safety and efficacy of registered complementary medicines;
  • Evaluating the quality and safety of new ingredients for use in listed complementary medicines;
  • Evaluating the efficacy of assessed listed medicines;
  • Liaising with stakeholders and sponsors in matters relating to the regulation of complementary medicines; and
  • Providing strategic input into regulatory reform projects relating to complementary medicines.

Duties of position

Specific duties include:

  • Applying technical expertise to process and evaluate the efficacy, safety or quality of non-prescription medicines with reference to relevant legislation and regulations as well as established policies and practices for inclusion in the Australian Register of Therapeutic Goods (ARTG) - the primary duty is likely to be evaluating efficacy of medicines and as such, statistics training is highly desirable;
  • Providing assistance with, and drafting, technical and scientific recommendations and reports in relation to applications for the registration of new, or variations to existing, non-prescription medicines;
  • Preparing correspondence to industry based on the outcomes of reviews/evaluations and contribute to other relevant documents as required;
  • Liaising, engaging and collaborating with internal and external stakeholders on complex technical matters;
  • Planning and monitoring work flows and taking responsibility for the achievement of team outcomes;
  • Assisting with the streamlining of applications to ensure efficient processes within applicable timelines; and
  • Undertaking other tasks as required and directed.

Mandatory requirements

Candidates must be able to demonstrate:

  • Sound scientific knowledge and ability to evaluate clinical trials.
  • High level analytical capability in a relevant scientific discipline and experience in writing scientific reports.
  • Well-developed written and oral communication skills with experience in scientific writing.
  • The ability to evaluate scientific data using professional judgment, factoring in risks and being sensitive to context.

Desirable

  • Understanding of statistics used in clinical trials.
  • Experience in the evaluation and regulation of therapeutic goods.
  • Experience in the evaluation of therapeutic bioequivalence data

Eligibility Requirements

  • A National Police Certificate (obtained within the last 6 months) will be required for the successful candidate.
  • Australian Citizenship is essential

If you feel you are a suitable candidate submit your application by hitting "Apply for this job". Alternatively, you can call Leanne Porter on 02 6268 9926 or email Leanne.Porter@chandlermacleod.com for further discussion.