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Medical Officer vacancies at the TGA
The Australian community rightly expects that medicines and medical devices in the marketplace are effective, safe and of high quality. Staff at the Therapeutic Goods Administration (TGA) work to ensure the quality, safety and efficacy of therapeutic products supplied on the Australian market or exported from Australia. This is achieved through pre-market assessment before products can be put on the market and through post-market monitoring and the licensing of Australian manufacturers and verifying that overseas manufacturers comply with the same standards as their Australian counterparts.
The TGA operates at the cutting edge of new technology assessment and the ongoing regulation of established therapies. It provides medical practitioners with opportunities to make a difference in an active learning, team-based environment.
The TGA employs about 35 medical officers, at various levels, in both full and part time positions. Additionally we consistently seek applications from medical practitioners interested in working as medical officers at the TGA with non-ongoing opportunities.
The work involves detailed scientific assessment, and provision of advice, on the safety and efficacy, and post market monitoring, of medicines, as well as in the field of medical devices and blood and tissues products.
Medical officers work as
- primary reviewers of data packages to support product approvals or variations;
- as decision-makers on granting and maintaining marketing approval for products;
- as advisers and assessors on clinical trial matters; and as advisers generally to other scientists and staff at the TGA.
TGA medical officers contribute to the development of regulatory standards, practices and guidelines at both the national and international level, which impact on public health here and overseas.
Entry level positions are usually as general reviewers at the Medical Officer Class 2 level. However, the career structure within the TGA enables medical officers to progress to Medical Officer Class 6. On the job and internal course training are provided, and TGA medical officers are able to access study leave and other support programs in order to undertake external study programs in various health-related topics.
The pace of change in medical research and product development is rapid, and employment as a medical officer at the TGA offers the challenge of working in a changing and evolving scientific environment. The multidisciplinary nature of therapeutic products regulation is a feature of working at the TGA. TGA medical officers work closely with pharmacists, microbiologists, biomedical engineers, statistical experts and other scientists in a supportive team environment.
The majority of medical officer vacancies are located in the Symonston office (ACT). However, the TGA may consider offering positions, should they arise, in the Melbourne and Sydney offices. This will depend on the requirements of the position and the capabilities of the successful applicants. There may also be some opportunities for home-based work but feasibilities would be assessed on an individual basis.
Medical officers at the TGA are involved in a number of different activities. The following provides a basic overview of some of the typical tasks performed at each level.
- read and critically assess scientific data presented by a sponsor seeking to supply a medicine or medical device for therapeutic use or to change the approved particulars of products already on the Register;
- evaluate product information concerning medicines to determine whether all relevant information including adverse reactions, hazards, contraindications are adequately communicated to the medical and allied professions by the manufacturer or distributors. Assess claims regarding efficacy and indications for use. Prepare class statements for product information;
- undertake investigations of clinical information provided to support applications for new uses, new dosage regimens, and new routes of administration for products already on the register; and
- prepare concise, written reports detailing the outcome of the evaluation and make appropriate recommendations.
- in addition to the range of duties of a Medical Officer Class 1 undertake special projects and detailed evaluations of:
- medicines on the Register with regard to claims for clinical safety and efficacy,
- applications by medical practitioners for release of unregistered medicines for use in specific patients (Special Access Scheme), and
- prepare reports on adverse reactions and on the therapeutic use of medicines, including material for publication;
- provide professional support to TGA internal and statutory committees, assist with actions arising, and advise TGA staff about the professional and technical aspects of incoming reports and information; and
- undertake clinical and/or research duties/studies related to professional development and continuing education.
Under limited supervision:
- assist with the training and mentoring of Medical Officers Class 1 and 2 across the range of tasks performed at their respective levels;
- undertake research into the safety of medicines and medical devices including the benefits and risks of their use;
- prepare reports and undertakes evaluations for submission to the TGA's expert committees, including FOI requests and the provision of technical input to Departmental and Ministerial documentation and liaise with the TGA's stakeholders when required and provide technical advice;
- maintain communications with medicines regulatory agencies in other countries, the WHO, healthcare professionals, the pharmaceutical industry and hospital authorities on matters relating to the safety of medicines; and
- liaise with the medical profession and pharmaceutical industry.
Be responsible for:
- exercising a high level of professional knowledge and competence, assist in the management of the Office/Section and provide training and guidance to Medical Officers Class 2 and 3;
- assist in the pre-registration evaluation and post-marketing surveillance of the quality, safety and efficacy of specific categories of medicines and medical devices intended for supply in Australia;
- assess the clinical implications of alleged incidents involving therapeutic products, recommend action, and in certain cases, implement such action as part of a sound post-market procedure;
- assess and advise on priorities and on policies to maximise the quality, safety and efficacy of therapeutic products;
- provide expert advice to the Department of Health and Ageing (DOHA), expert advisory committees, and internal and external stakeholders when required;
- investigate and advise on reports of suspected adverse reactions to medicines or medical devices, including policy implications. Prepare reports on the use of medicines or medical devices and adverse reactions, including material for publication;
- prepare briefs and medical advice for Ministerial submissions and correspondence and represent the Department and the TGA as an adviser at meetings and conferences; and
- undertake approved clinical and/or research studies duties.
Be accountable for:
- exercising a very high level of professional knowledge and competence;
- leading and manage a team engaged in the pre-registration evaluation and post-registration surveillance of the quality, safety and efficacy of specific categories of medicines and medical devices or investigating and advising on reports of suspected adverse reactions to medicines or medical devices and prepare reports on the use and medicines or medical devices and adverse reactions;
- providing expert advice on therapeutic products to committees, both internal and external stakeholders, and represent the Department and the TGA at meetings and conferences;
- leading and/or contribute to the formulation and implementation of new policies in relation to the evaluation and regulation of medicines and medical devices;
- monitoring international activities relating to the regulation of therapeutic products and, where necessary, advise on adopting these activities into TGA regulatory activity;
- investigating and advise on reports of suspected adverse reactions to medicines or medical devices, including policy implications - prepare reports on the use of medicines or medical devices and adverse reactions, including material for publication; and
- undertaking approved clinical and/or research duties to maintain a high standard of professional knowledge.
The TGA is part of the Department of Health and Ageing (DoHA) and employment conditions are covered under the DoHA Enterprise Agreement 2011-2014. TGA Medical Officer Class 5 positions are not covered by the CA and are determined by the Secretary of the Department. These include, but are not necessarily limited to the opportunity for accumulation of long service leave, access to maternity leave and access to purchased leave arrangements. TGA medical officers are usually not required to be on call or to work on weekends.
The TGA's vision is to apply world's best practice in the regulation of therapeutic products to benefit the community's health and well-being. To achieve this, the TGA recognises the critical importance of skilled, professional staff and a culture of high performance, continuous learning and scientific excellence.
The TGA is committed to providing learning and development opportunities to staff to achieve this vision. These can include access to post-graduate study, such as a Graduate Diploma in Clinical Research Methods or a Master of Public Health in the Clinical Epidemiology/Clinical Research stream. In addition to developing technical and specialist skills, the TGA also provides opportunities to attend a variety of management and information technology courses and undertake job rotations through TGA Offices.
TGA has established an internal Continuing Professional Development program for TGA Medical Officers as part of an overarching strategy to proactively address skill maintenance, and the attraction and retention of staff at TGA. The program is focussed on topics relevant to the work of the TGA and key public health issues which includes ninety minute education sessions and a journal club alternate on a weekly basis. Sessions are presented by both TGA staff and visiting external experts with Medical Officers in Melbourne and Sydney accessing the sessions via video conferencing facilities.
Medical officers are eligible to receive a PDA of $4500 each financial year on a reimbursement basis, to assist in attaining and maintaining work relevant and agreed skills and knowledge. Part time medical officers will have access to the full amount of PDA.
Approved medical officers may engage in private medical practice to a maximum of half a day per week (averaged over a 12 month period) during normal working hours, with no adjustment to salary.
Medical officers may access up to an additional four half days per month during normal working hours for private medical practice subject to operational requirements and the agreement of the unit head and the TGA Principal Medical Advisor. This additional time will be taken as leave without pay or may be approved to be made up at another time.
Access to private medical practice will be pro rata for part time medical officers.
Medical Officers salary ranges are available at: Salary ranges
The Medical Officer Class 5, as a senior executive equivalent position, is subject to different arrangements as determined by the Secretary.
There is scope for applicants with exceptional skills and attributes to be remunerated beyond the salary scale for the particular classification level, for example, through an allowance determined by the Secretary.
To be eligible for a medical officer position, you must be registered as a Medical Practitioner under the Medical Board of Australia's National Registration Laws.
Information on how to apply is available on: How to prepare your job application.
The TGA uses a behaviourally based competitive selection process where all applicants are assessed against six capabilities. The six key capability areas are:
Capability 1: Aligns with Organisational Goals/Contributes to Strategic Thinking
- Encourages a shared sense of purpose and direction
- Shows judgement, intelligence and common sense
- Focuses strategically
- Harnesses information and opportunities
Capability 2: Achieves Results
- Ensures closure and delivers on intended results
- Builds organisational capability and responsiveness
- Steers and implements change and deals with uncertainty
- Marshals professional capability
Capability 3: Supports/Cultivates Productive Working Relationships
- Nurtures internal and external relationships
- Values individual differences and diversity
- Facilitates co-operation and partnerships
- Guides, mentors and develops people
Capability 4: Shows/Exemplifies Personal Drive and Integrity
- Demonstrates professionalism and probity
- Displays resilience
- Demonstrates self awareness and a commitment to personal development
- Engages with risk and shows personal courage
- Commits to action
Capability 5: Communicates Clearly and Effectively/Communicates With Influence
- Communicates clearly and concisely
- Listens, understands and adapts to different audiences
- Negotiates persuasively
Capability 6: Applies and Builds Appropriate Skills, Knowledge and Experience (for Medical Officers this capability will be Professional Expertise).
- Builds, applies and maintains appropriate experience, skills and knowledge
- Maintains and demonstrates professional/technical qualifications and specialist expertise
- Demonstrate a high level of professional knowledge and competence to ensure the quality, safety and efficacy of therapeutic products in Australia
If you are assessed as suitable for any of our current specific vacancies (http://tgacareers.nga.net.au/cp/), the selection panel may contact you to seek further information. This could take the form of either:
- a request to provide further details against the capabilities for the vacancy; and/or
- a request to respond to specific technical questions
Successfully shortlisted medical officer applicants will be invited to attend interviews. Contact and confirmation will be made by the TGA Recruitment Team via email and letter. The TGA aims to finalise recruitment activities as quickly as possible and has set a target of 6-8 weeks from the application closing date to the final decision.
Following my over 25 years of various clinical work, in early 2006 I joined TGA as a clinical evaluator and since then I have never looked back. This is because, on a professional side:
- I can make good use of my clinical skills, which has been highly fulfilling professionally, and for which I am satisfactorily remunerated;
- I am totally independent in formulating my opinions and providing scientific reviews and recommendations;
- I have ample opportunities related to my professional development and continuing education thanks to having access to cutting edge scientific information and training; and
- I highly value the privilege of being part of a prestigious organisation - one of the world's leading regulators of therapeutic products.
Those professional aspects of my employment are complemented by flexible - including part-time when needed - working arrangements in a genuinely friendly workplace atmosphere.