Aps Level 3

**Job Reference Number **22-MRDIV-15234

**Classification **APS Level 3

**Job Title **Administrative Support Officer

**Division **Medicines Regulation Division

**Branch **Prescription Medicines Authority Branch

**Section **Application and Advisory Management Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$65,056 - $72,110

**Contact Officer Name**:Lindsey Carroll
**Phone**:02 6289 6878

**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 Therapeutic Goods Administration (TGA) is part of Australian Government Department

of Health and Aged Care and is responsible for safeguarding and enhancing the health of the

Australian community through the effective and timely administration of the Therapeutic

Goods Act 1989. The TGA's overall purpose is to protect public health and safety by

regulating therapeutic goods, such as medicines, medical devices, biologicals, human blood,

blood products and tissues. The Medicines Regulation Division (MRD) is responsible for

medicines for supply in Australia. The Division 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:

- Prescription Medicines Authorisation Branch (PMAB)
- Scientific Evaluation Branch (SEB)
- Pharmacovigilance Branch (PB)
- Complementary and Over-the-counter Medicines Branch (COMB)
- International Regulatory Branch (IRB)

**Branch Responsibilities**

The Prescription Medicines Authorisation Branch (PMAB) is responsible for evaluating new

chemical entity prescription medicines, leading to an approval or rejection decision.

Through evaluating the clinical aspects of clinical medicines, PMAB ensures medicines

available for supply in Australia are safe, fit for their intended purpose and available in a

timely manner. The branch also approves clinical aspects of variations to registered

medicines and participates in a number of transparency initiatives.

**Section Responsibilities**

The Application and Advisory Management Section is responsible for:

- Managing the prescription medicines registration process in accordance with

relevant legislation and established business processes.
- Providing specialist advice on the market authorisation process to internal and

external stakeholders to resolve complex and sensitive issues.
- Coordinating and procuring external expertise to contribute to the market

authorisation process.
- Leading business process reforms to the prescription medicines registration process

**Key Responsibilities**
- Triaging enquiries from internal and external stakeholders to members of the case

management team.
- Answering incoming phone calls and escalating them appropriately to senior team

members.
- Providing administrative support throughout the prescription medicines registration

process.
- Assisting with drafting responses to straightforward enquiries from internal and

external stakeholders.
- Recalculating milestones to ensure accurate communications and timelines for

sponsors.
- Completion of other administrative tasks as required to assist the case management

team and other members of the section.***

**Key Capabilities**
- The ability to complete allocated tasks with supervision.
- The ability to build rapport and maintain stakeholder relationships, including both

internal and external stakeholders.
- Demonstrated verbal and written communication skills.
- Demonstrated well-developed computer and keyboard skills with a working

knowledge of the Microsoft Office suite of products.
- Attention to detail.
- Contributing to team goals and broader organisational objectives by demonstrating

the flexibility to undertake additional tasks as required.
- The ability to work effectively in a small team and develop productive working

relationships.

**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 a