Short term contract opportunity within a division of the TGA.
Join a multi-disciplinary team in a collaborative work environment
Be at the forefront of the decision-making process
About the company
Government body based in Canberra responsible for the regulation of over the counter (OTC) and low-risk self-selected medicines, which include complementary medicines-traditional and herbal medicines, and vitamin and mineral supplements-that are supplied in Australia.
About the opportunity
The Scientific Evaluator will assess the compliance of low-risk medicines with legislative requirements for safety, quality and efficacy. This role provides an opportunity to gain experience in regulatory compliance and showcase your aptitude for innovation in the workplace.
- Undertake compliance reviews of listed medicines, including preparing timely, high quality technical and scientific reports that summarise and provide an independent assessment of the submitted data with respect to legislative requirements
- Recommend robust risk-based regulatory decisions or recommendations based on sound scientific evaluation and in-depth knowledge of legislative and administrative frameworks for listed medicines.
- Undertake complex research and analysis in order to prepare high quality technical and scientific recommendations, reports and guidelines;
- Make and communicate decisions that are based on professional judgement, evaluating risks and in the context of a complex and changing environment
- Provide strategic advice and technical expertise to guide project and program activities
- Prepare correspondence to industry based on the outcomes of evaluations/reviews and contributing to other relevant documents as required, including Ministerial briefing notes and submissions; and
- Contribute to continuous improvement and regulatory reform activities that are consistent with the strategic objectives of the TGA and the Government.
Skills and Experience
- Tertiary qualification in a scientific discipline;
- Knowledge of and experience in the regulation of therapeutic goods
- Experience with scientific evaluation of medicines
- Demonstrated ability to research issues, analyse problems and develop appropriate solutions or strategies
- Well-developed written and verbal communication;
The successful candidate will need to obtain a National Police Certificate.
How to Apply
Click apply or contact Joanna Murphy, Senior Recruitment Consultant on 02 8877 8718 for a confidential discussion.
( SK927795A )
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