Aps Level 5

2 days ago

Canberra, Australia Australian Government Therapeutic Goods Administration Full time

APS Level 5
- Canberra, ACT; Melbourne, VIC; Brisbane, QLD
- Medicines Regulation Division

The Biological Science Section of the Therapeutic Goods Administration (TGA) is recruiting for a number of APS Level 5 Scientific Evaluators.

The section undertakes assessment and approval of biological medicines and gene therapies, administration of the regulatory framework for biologicals (human cells and tissues), regulation of blood and blood components and the evaluation of infectious disease safety aspects of therapeutic goods.
- Undertake limited specialist or technical evaluation and analysis of prescription medicines, biologicals, blood components and medical devices
- Write evaluation reports of varied complexity for a range of therapeutic goods
- Draft decision letters under guidance
- Liaise with other staff within the organisation
- Coordinate handling of internal and external enquiries and manage inboxes
- Communicate with and provide advice to a wide variety of customers and external stakeholders
- Coordinate pre
- and/or post-assessment processes within the section
- Identify opportunities for business improvement activities within the Section, Branch or Division.

**Desirable skills and experience**:

- Scientific analytical ability demonstrated through work in a research, industry or regulatory environment;
- Strong organisational and time management skills, and the ability to manage multiple tasks;
- Good interpersonal, liaison and stakeholder management skills, including the ability to develop productive working relationships; and
- Good written and oral communication skills.

**Mandatory qualifications**:

- A relevant qualification in biological sciences from an Australian tertiary institution, or comparable overseas qualifications.

Applicant Kit

Applicant Kit

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