**Job Reference Number **22-MRDIV-15040
**Classification **APS Level 3
**Job Title **Administration Officer
**Division **Medicines Regulation Division
**Branch **International Regulatory Branch
**Section **Special Access Section
**Location **Fairbairn, ACT
**Status **Non-ongoing
**Employment type **Full-time
**Salary Range **$65,056 - $72,110
**Contact Officer Name**:Kiran Lal
**Phone**:02 62893047
**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 includes:
- Pharmacovigilance Branch (PSAB)
- Complementary and Over-the-counter Medicines Branch (COMB)
- Prescription Medicines Authorisation Branch (PMAB)
- Scientific Evaluation Branch (SEB)
- International Regulatory Branch (IRB)
**Branch Responsibilities**
The International Regulatory Branch is responsible for delivering aid programs through
funding from the Department of Foreign Affairs and Trade (DFAT). The Branch is
contributing to the Australian Government's priority in opening international borders
through providing scientific advice on the safety, efficacy, and quality of international
COVID-19 vaccines. IRB has responsibility for managing strategic international relations and
special access to specific therapeutic goods. IRB also oversees access to products not on the
Australian Register of Therapeutic Goods, but for which there is a clinical need, through
alternative access pathways such as the Special Access Scheme and Authorised Prescriber
scheme.
**Section Responsibilities**
The Special Access Section is responsible for administering the various mechanisms by
which unapproved therapeutic goods can be supplied in Australia, including the Special
Access Scheme (SAS) and Authorised Prescriber (AP) scheme and responds to enquiries from
internal and external stakeholders regarding access to unapproved therapeutic goods.
**Key Responsibilities**
- Maintain a basic understanding of Special Access Section (SAS) and Authorised
Prescriber (AP) legislation, guidance material and standard operating procedures
- Undertake data entry of SAS or AP submissions into the CRM system with accuracy
and efficiency, including assisting APS2 staff with more complex SAS data entry
- Assess submissions for validity and request missing information if required.
- Provide high quality customer service when liaising with external and internal
stakeholders including medical practitioners, patients and pharmaceutical industry
representatives.
days).
straightforward information on access schemes using templates within 2-5 business
days.
of errors.
- Answer the Special Access Section phone line and respond to routine enquiries
regarding SAS and AP submissions and other straightforward information on access
schemes.
- Liaise with lead administration officer or pharmacist to investigate SAS/AP
stakeholder issues and offer resolutions. Escalate complex issues and
correspondence to a pharmacist.
- Assign responses to Requests for Information (RFI) relating to incomplete SAS or AP
- Organise and file documentation in TRIM consistent with the TGA Records
Management Policy.
- Perform basic data retrieval and basic analysis to support projects, assist with high
- level enquiries and Freedom of Information (FOI) requests.
- Assist in training and supporting new staff members.
- Perform other duties as requested by supervisor or Director.
**Key Capabilities**
- Well-developed organisational skills and be adaptable to change.
- Strong written and oral communications skills.
- The ability to work effectively and collaboratively with colleagues in a team
environment.
- The ability to develop and maintain effective working relationships with internal and
external stakeholders.
- Demonstrated ability to plan and organise work, including the ability to meet
deadlines with competing priorities and deliver work accurately and to a high
standard.
**Minimum Requirements
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