5 days left
- Full Time
Medical Officer Class 5
This is a key leadership role leading a team of professional medical and scientific staff and working to support the TGA and the Department of Health
- 15.4% employer contribution to superannuation.
- Flexible and competitive working conditions.
- Excellent conditions and remuneration.
The Prescription Medicines Authorisation Branch in Medicines Regulation Division is responsible for evaluating prescription medicines, leading to an approval or rejection decision.
The Medical Officer Class 5 in Clinical Evaluation Unit 6 is the delegated decision maker for evaluation of applications for registration of haematology medicines, which includes cancer treatments. This is a key leadership role, leading a team of professional medical and scientific staff and working more broadly to support the branch, TGA and the Department of Health.
Applications are sought from candidates with a degree in medicine and relevant clinical experience to fill the MO5 role. The successful candidate must have demonstrated strategic leadership, team management and communication skills.
The Medical Officer Class 5 (MO5) is a key leadership role within Medicines Regulation Division, with an emphasis on leading a team for evaluation and decision making for the market authorisation of haematology/blood cancer medicines. Medical officers at this level require a very high level of professional knowledge and skills in a specific field(s) of medicine, including pharmacology, epidemiology and regulatory science. The successful candidate must also have demonstrated strategic leadership, team management, organisational, communication and stakeholder management skills.
Major responsibilities of the role include:
- Managing a team of professional medical and scientific staff across the branch.
- Providing significant strategic policy direction, business process improvements, leadership, supervision, peer support, mentoring and training to the branch and to the TGA more broadly.
- Understanding the regulation of therapeutic goods in Australia to maintaina high level of autonomy, implement reform work, and make decisions in accordance with the regulatory framework, the strategic direction of the Department and the PGPA Act.
- Taking the lead on the preparation of advice to the branch, TGA, Departmental Executive, Minister and Committees on issues concerning the prioritisation, registration and scheduling of medicines.
- Ensuring the preparation of high quality, timely and professional medical and scientific evaluation reports from internal and external medical officers in relation to the safety of medicines, and the preparation of material on the safety of medicines for publication.
- Assessing medicines for quality, safety and efficacy as part of pre-market processes.
- Making decisions on behalf of the Secretary to approve, remove and/or restrict regulated medicines for sale/supply or to register new medicines for marketing in Australia in accordance with a risk based framework.
- Monitoring international developments and liaising with stakeholders and peers including overseas regulatory authorities, the World Health Organisation, health care professionals, industry, consumers, state and territory health departments and hospital authorities on matters relating to the safety of medicines.
- Representing the Department at meetings, committees and international forums as required.
- Qualifications and experience as a medical practitioner.
- Ability to both coordinate, undertake and author complex analyses and interpretation of clinical data and application of significant judgement in making decisions on the registration of prescription medicines.
- Ability to assimilate and apply comprehensive knowledge of related areas of medical specialisation and a well-informed knowledge of medico-political issues.
- Demonstrated ability in leading, supervising, training and coaching a team of professionals to achieve results.
- High level written and verbal communication skills and an ability to liaise effectively with a diverse range of stakeholders, including senior committee members and Departmental staff.
- Ability to develop productive working relationships with peers, reports and stakeholders to identify opportunities, achieve outcomes and facilitate cooperation.
- Ability to assist a team to prioritise tasks, respond positively and flexibly to change and produce quality outputs to tight and competing deadlines.
- Ability to deliver the objectives of the Branch plan as well as ensure the efficient running of the clinical stream and branch.
- A degree in Medicine, registration with the Medical Board of Australia or the ability to obtain this, and relevant clinical and supervision experience.
- Registration as a medical practitioner with the Medical Board of Australia.
- Experience in haematology or oncology fields.
- Team leadership of professionals.
- Experience in regulation and/or medicine development.
For further information and to submit an application please click the apply button.
Applications close Monday 26 November 2018, 11:30pm AEDT.