Aps Level 5

**Position Description**
**Job Reference Number **22-MRDIV-16233
**Classification **APS Level 5
**Job Title **Administration Officer
**Division **Medicines Regulation Division
**Branch **Prescription Medicines Authority Branch
**Section **Applications Support and Export Section
**Location **Fairbairn ACT
**Status **Ongoing
**Employment type **Full-time
**Salary Range **$79,002 to $85,437 per annum
**Desirable Qualifications **- Demonstrated working knowledge and understanding of the
- TGA’s legislative and technical regulatory framework.- Understanding of the regulatory framework for medicines in

Australia and an understanding of the prescription
medicines stakeholder environment.

**Contact Officer Name**:Liz Santolin
**Phone**:02 6289 3164

**Eligibility**
To be eligible for employment with the Department of Health and Aged Care

applicants must be an Australian citizen at the time an offer of employment is made

An applicant’s suitability for employment with Health will also be assessed through a
variety of pre-employment check processes, such as:
Satisfactory completion of an Australian Federal Police criminal history check,

and where relevant a Working with Children and Vulnerable People Check.
Completion of a medical declaration and pre-employment medical (where

required).
Providing evidence of qualifications.

**Division Responsibilities**
The Medicines Regulation Division (MRD) is responsible for undertaking evaluations of
Australia.

MRD staff make decisions whether to approve or reject market authorisation of medicines
that are imported, exported, manufactured and supplied in Australia. 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 Branch (PB)
- Prescription Medicines Authorisation Branch (PMAB)
- Scientific Evaluation Branch (SEB)

**Branch Responsibilities**
The Prescription Medicines Authorisation Branch (PMAB) at the Therapeutic Goods
Administration (TGA) is responsible for processing and evaluating new prescription
medicines, new uses of medicines and other variations to medicines, leading to an approval
or rejection decision. Through evaluating the premarket clinical aspects of prescription
medicines, and with advice from other branches in the TGA, PMAB ensures that these
medicines are safe, efficacious, and become available in a timely manner.

**Section Responsibilities**
The AESE is responsible for several functions, including receipt and assistance with the
the ARTG and to ensure that prescription medicines are included on the ARTG after the
medicines in the ARTG, issuing blood and tissues export permits and providing export
certification for both medicines and medical devices.***

**Key Responsibilities**:

- Ensuring the accuracy and currency of the ARTG is maintained by efficiently

prescription medicines and/or export-only medicines in accordance with the
- Therapeutic Goods Act 1989_ (the Act).
- Managing or assisting with enquiries from internal and external stakeholders via
- telephone or shared inbox and providing accurate and timely responses.- Appropriately escalating and assisting with resolving issues by liaising with internal
- and external stakeholders.- Providing support and training to other staff as required.
- Contributing to regulatory reform and business improvement projects.
- Providing support to the AESE, PMAB and broader organisation as required.***

**Key Capabilities**:

- Demonstrated understanding of legislation relating to prescription medicines.- Knowledge of the TGA’s requirements for the registration of prescription medicines.
- Well-developed written and verbal communication skills.
- Demonstrated ability to manage competing priorities and tight deadlines.
- Demonstrated ability to form strong working relationships with internal and external
- stakeholders.- Demonstrated ability to work independently and self-motivate.

**Minimum Requirements**
RecruitAbility is a scheme which aims to attract and develop applicants with disability and
also facilitate cultural changes in selection panels and agency recruitment. All vacancies for
the Department of Health and Aged Care are advertised under the RecruitAbility Scheme.

Job applicants with disability who:

- opt into the scheme
- declare they have disability, and
- meet the minimum requirements of a vacancy advertised under the scheme

are advanced to a further stage in the selection process.

More information on RecruitAbility can be found here: RecruitAbility scheme: A guide for
applicants

Minimum requirements for this role include:

- Demonstrated understanding of legislation relating to prescription medicines.
- Knowledge of the TGA’s requirements for the registratio