12 months from commencement
Possibility of extension
Background information on Section and Branch
The Branch is responsible for post market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment for therapeutic goods. The branch conducts laboratory testing in accordance with the laboratories testing program; lot release; provides scientific expertise to assess technical data for marketing authorisations; provides scientific and expert advice to internal stakeholders, committees, government etc.; and participates in the development of standards and international collaborative activities.
Duties of position
Specific duties include:
- Undertaking complex evaluations of documents, applications and submissions for the registration of therapeutic products including vaccines and a range of vaccines and biomedicines, to ensure they meet regulatory requirements and professional quality standards in line with the application of a risk based approach to regulation;
- Preparing timely, high quality reports that summarize and provide an independent scientific assessment of the data submitted;
- Scientific evaluation of some or all aspects of a submission, specifying how any deficiencies in submissions may be remedied;
- Assist team members in preparing guidelines and policy documents and assessment of international guidelines;
- Liaising, engaging and collaborating with internal and external stakeholders to resolve complex and/or sensitive issues in relation to compliance with legislation, regulations and standards;
- Assist in building team and laboratory capability and contributing to business improvement and cultural change initiatives;
- Working flexibly in a high pressure environment to achieve team goals and broader organizational objectives by providing management support, contributing to other tasks and projects as required and directed.
Candidates must be able to demonstrate:
- Strong scientific knowledge, preferably in vaccines or biological medicines/sciences;
- High level analytical capability in a relevant scientific discipline and experience in writing scientific reports;
- High level written and verbal communication skills;
- The ability to contribute ideas and support organizational goals;
- A sound understanding of the regulatory framework for therapeutic goods in Australia, including applicable standards and guidelines, or demonstrated ability to rapidly learn and apply this knowledge;
- The ability to evaluate scientific data using professional judgment, factoring in risks and being sensitive to context;
- High level interpersonal, liaison and stakeholder management skills, including the ability to develop productive working relationships to identify opportunities, facilitate cooperation and achieve outcomes;
- The ability to work flexibly in a high pressure environment while responding positively and flexibly to change;
- The ability to strategically overcome roadblocks to deliver and drive projects.
- Post-graduate qualifications and an understanding of the Australian therapeutic goods regulatory environment would be highly regarded.
If interested, please apply directly through the links provided. Alternately, contact Kalpana for more information.
0403 200 666
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Due to the nature of this role, Australian Citizens need only apply.