This Federal Government branch is responsible for processing and evaluating applications for new prescription medicines, new uses of prescription medicines and other variations to prescription medicines currently registered on the ARTG. Through evaluating the pre market clinical aspects of prescription medicines, and with advice from other branches in the TGA, this branch helps facilitate the supply of prescription medicines that are safe for their intended use, efficacious and available in a timely manner.
About the position
This role will support the Director to establish a frameworks for the evaluation. Advanced medicines and therapeutics within the TGA. The key responsibilities include but are not limited to:
• Progress work in defining role, scope and responsibilities;
• Investigate knowledge and capability gaps, investigates how other international regulators assess this group of products
• Develop procedures and policies regarding the regulatory approach to advanced therapies;
• Develop educational material for the intranet and internet so that external stakeholders understand how the TGA regulates these products
• Develop a co-ordinated approach to enquiry management within the section;
• Work closely with other internal sections of the TGA such as biologicals, laboratories, case managers, clinical evaluation sections, clinical trials, PSAB, and the Executive;
• Work closely with other external stakeholders such as TAAD, Department of Health, Develop and progress activities in accordance with section and branch priorities; and
• Ongoing professional development in this therapeutic area.
The Project Officer role require the following key capabilities:
• Self-management of competing priorities with tight timeframes;
• Create well-written content for a range of audiences rapidly and with minimal rework required;
• Work co-operatively and effectively in a team environment;
• Manage in an ambiguous and rapidly adjusting workplace; and
• Develop and maintain positive personal relationships with internal and external stakeholders.
• Undergraduate +/- post graduate training in a relevant area such as medicine, science, drug development, public health or pharmacology;
• A National Police Certificate (obtained within the last 12 months) will be required for the successful candidate.
• A Baseline security Clearance is required for this position.
• Knowledge of medicine/science, in particular in relation to gene and cell therapies, medicine regulation;
• Project and policy development experience;
• Experience in scientific or medical writing;
• Experience in or sound knowledge of, the regulation of therapeutic goods in Australia;