Executive Level 1

**Job Reference Number **22-MRDIV-15145

**Classification **Executive Level 1

**Job Title **Assistant Director

**Division **Medicines Regulation Division

**Branch **Prescription Medicines Authorisation Branch

**Section **Business Systems Review & Reporting Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$108,680 - $123,951

**Desirable Experience **- Experience in leading teams providing business systems
support.
- Experience in business analysis and/or process

engineering.
- Experience in regulatory information systems would be

highly regarded.
**Contact Officer Name**:Garry MacGregor
**Phone**:0418 205 547

**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

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 has been a crucial part of the rollout of COVID-19 vaccines in Australia and

ongoing safety monitoring of their use. The Division includes:

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

**Branch Responsibilities**

The Prescription Medicines Authorisation Branch (PMAB) sits within the Medicines

Regulation Division (MRD) and 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 several transparency initiatives.

**Section Responsibilities**

The Business Systems Review & Reporting section (BSRR) is a multi-disciplinary team

providing a range of services that support the registration of medicines in Australia. Key

business intelligence, development of transparency related documents, and coordination

services for the Advisory Committee on Medicines.***

**Key Responsibilities**

This role owns the strategic delivery of Process & Systems Services within the section. With

a small team, this role will deliver:

- Advancement of the usage of key business systems in the Branch and Division.
- An effective training model for business systems controlled by the section.
- Active engagement with vendors the IT division to ensure reliability and accessibility

of business systems.
- Support for process improvement across the division. It is expected the incumbent

will be highly organised as these services are time dependent and rely on a broad

range of staff to provide coordinated input. This role is not a helpdesk service but

will assist in diagnosing system issues.***

**Key Capabilities**

The Process & Systems Services role key capabilities include:

- Supporting staff in the Branch and Division to adopt best practices with systems.
- Supporting a regulatory information management system.
- Driving change and reform, including influencing teams to effectively use business

systems.
- Managing self and staff to ensure productivity.
- Leading multidisciplinary teams as necessary.

**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:

- Background in leading small teams to support business system