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Medical Officer vacancies at the TGA

Introduction

The Australian community rightly expects that medicines and medical devices in the marketplace are effective, safe and of high quality. TGA staff 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 approximately 30 Medical Officers, at various levels, in both full and part time positions. We are regularly seeking applications from medical practitioners interested in working as a Medical Officer at the TGA. 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. There are opportunities for Medical Officers to represent the TGA at meetings both in Australia and internationally. Medical Officers also 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. The TGA works closely with other regulators around the world, particularly in areas of the licensing of manufacturers of medicines through membership of the International Pharmaceutical Inspection Co-operation Scheme and, in medical devices, through membership of the Global Harmonisation Task Force for medical devices.

Entry level positions are usually as general reviewers at the Medical Officer Class 1 or 2 level however, the career structure within TGA enables Medical Officers to progress to the Medical Officer Class 6 level. On the job training and internal course training are provided and TGA Medical Officers are also able to apply 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. As a Medical Officer, you will work closely with pharmacists, microbiologists, biomedical engineers, statistical experts and other scientists in a supportive team environment.

About the TGA

Around 530 people work for the TGA. Most of these people work at the impressive head office and laboratories at Symonston in the ACT where medical practitioners, pharmacists, pharmacologists, other scientists, and administration professionals undertake rigorous assessment, monitoring and regulation of medicines, medical devices, blood products and tissues. Internationally the TGA is regarded as one of the top regulators of therapeutic products.

The work of the TGA is assisted by a range of expert advisory committees which provide valuable input from eminent practicing health professionals or from leading Australian academic institutions.

The work environment

Office of Medicines Safety Monitoring

The Office:

  • receives reports of adverse drug reactions from medical practitioners, hospitals, pharmaceutical companies and consumers throughout Australia
  • liaises with overseas medicines regulatory agencies and the World Health Organisation on matters relating to adverse reactions
  • services the Adverse Drug Reactions Advisory Committee (ADRAC)
  • analyses reports of adverse reactions to medicines
  • offers regulatory advice within the TGA
  • prepares material for publication

Office of Prescription Medicines

The Office:

  • carries out detailed evaluations of the content of applications to register new medicines (including the evaluation of data from clinical trials)
  • reviews the safety and effectiveness of older medicines and applications to modify the use of medicines already in the Australian Register of Therapeutic Goods
  • prepares complex scientific reviews and advice
  • reviews Product Information and Consumer Product Information
  • approves use of unregistered medicines under the Special Access Scheme or as part of a clinical trial

Office of Devices, Blood and Tissues

The Office:

  • administers the special access schemes for medical devices, blood, tissue and cellular therapies
  • oversights the requirements for clinical trials for medical devices, blood and tissues
  • evaluates and advises on clinical aspects of medical devices, blood, tissues and cellular therapies
  • prepares clinical evaluation reports for new medical devices and other therapeutic products
  • liaises with the medical profession and medical device industry on issues of regulation of medical devices, blood and tissue therapies
  • investigates post market incident reports
  • provides advice on clinical aspects of promotional claims of therapeutic products

Medical Officer duties

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.

Medical Officer Class 1

Under supervision:

  • 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
  • prepare concise, written reports detailing the outcome of the evaluation and make appropriate recommendations

Medical Officer Class 2

Under supervision:

  • 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)
    • 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
  • undertake clinical and/or research duties/studies related to professional development and continuing education.

Medical Officer Class 3

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 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
  • liaise with the medical profession and pharmaceutical industry

Medical Officer Class 4

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
  • undertake approved clinical and/or research studies duties

Medical Officer Class 5

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
  • undertaking approved clinical and/or research duties to maintain a high standard of professional knowledge

Medical Officer employment arrangements

The TGA is a Business Unit of the Department of Health and Ageing (DoHA) and employment conditions are covered under the DoHA Collective Agreement (CA). Medical Officer 5 positions are not covered by the CA and are determined by the Secretary of the Department. These include the opportunity for accumulation of long service leave, access to maternity leave and access to purchased leave arrangements. Medical Officers are usually not required to be on call or to work on weekends.

In addition to the standard employment conditions, Medical Officers are also able to access the following conditions:

Professional Development Allowance (PDA)

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.

Absences for professional development purposes

As part of the performance management process Medical Officers will identify and agree their learning and development needs with their team leader. Where a Medical Officer attends training or courses identified as a result, they will be considered to be on duty and no leave application will be required. In addition, attendance at conferences and seminars may be granted where it is directly relevant to the Medical Officers current role, having regard to any necessary medical registration, medical college requirements or operational requirements.

Private practice

Where 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 Principal Medical Advisor. This additional time will be taken as leave without pay or 'made up' at another time.

Access to private medical practice will be pro rata for part time Medical Officers.

Learning and development opportunities

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, 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, TGA also provides opportunities to attend a variety of management and information technology courses.

Employment flexibility

One of the advantages of working in the APS, and at the TGA, is the flexible employment arrangements. In addition to an annual entitlement to 4 weeks recreation and 18 days sick/carers leave, Medical Officers also have access to maternity and long service leave after a qualifying period. There is also provision to purchase an additional 6 weeks leave per year.

Several Medical Officers take advantage of part time employment arrangements where they organise their attendance pattern around workload and personal commitments.

Location

The TGA is located in Canberra in the suburb of Symonston. This is a semi-rural environment but only a short distance from the major commercial centres. Few staff would travel more than 20 to 30 minutes to or from work by car, and parking at TGA is free. Public transport bus services deliver and pick up passengers from the TGA front gate. The TGA also offers an on-site professional library, a staff canteen and sporting facilities, including an on-site gym with very competitive membership costs.

Although Medical Officers vacancies have traditionally been located in our Symonston office we will consider offering positions in our 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 the feasibility of this will have to be assessed on a case by case basis.

Medical Officer salaries

The following Medical Officers salary ranges are effective from August 2008:

Level From To
Medical Officer Class 1 $92,263
Medical Officer Class 2 $100,962 $106,379
Medical Officer Class 3 $112,890 $118,198
Medical Officer Class 4 $123,109 $135,507
Medical Officer Class 5 $160,680  

These rates are due to increase by 4.1% in August 2009 and by 4.25% in August 2010. The MO5 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.

Eligibility

To be eligible for a Medical Officer position, you must be registered as a Medical Practitioner under the laws of an Australian State or Territory

How to apply

If you are interested in submitting an application for a Medical Officer position, please complete the Medical Officer Application Coversheet, and send it, together with your Curriculum Vitae, to .

Your Resume or CV should be a summary of personal history. It should contain all relevant information about your education, employment/professional experience (most recent first), achievements etc. Try to provide a complete picture without being too lengthy.

There are also a few questions on the Application Coversheet that have been developed to collect some additional information that is not readily available from your CV.

The selection process

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

  • 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

Your resume and application coversheet will be assessed against the capabilities described above. If you are assessed as suitable for any of our current specific vacancies, the selection panel will 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; and/or
  • an invitation to attend an interview and a work sample test.

The TGA aims to finalise selections as quickly as possible and has set a target of 6 weeks from the application closing date to the final decision. Please ensure you include phone and email contact details so that we can easily contact you - it would also assist if you could indicate if you will not be available to attend an interview at any particular time in the next 6 weeks.

Submitting an application

Once you have completed your application, you can:

Or

  • Fax it to 02 6203 1338

Alternatively, you can:

  • Post it to:
    • The Recruitment Officer
      Therapeutic Goods Administration
      PO Box 100
      WODEN ACT 2606

Or

  • Hand deliver it to:
    • The Recruitment Officer
      Therapeutic Goods Administration
      136 Narrabundah Lane
      SYMONSTON ACT 2609

Coversheet

Testimonials from current TGA Medical Officers

Following my over twenty five 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
  • 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.

I joined the TGA for a different career from clinical practice and as a junior medical officer the TGA provided the right support and balance of work and lifestyle I wanted to pursue my interests in clinical trials and pharmaceuticals. As a leading regulator of therapeutic goods, the TGA has given me the opportunity to work in a friendly environment with flexible working conditions and support from dedicated professional staff. I've been able to develop my skills and knowledge in pharmaceutical regulation through post-graduate studies, professional development activities and in-house training to progress from being a clinical trial evaluator to a manager of a team of medical doctors and professionals. I enjoy working here and would recommend to any doctor thinking of a change to give us a go and be part of a team contributing to Australia's health through safe, effective and high quality medicines.

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