Living & Working in Australia

In the last 25 years, Australia has become the number one destination for permanent migration. The country's non-discriminatory immigration policy guarantees that any person can apply to migrate to Australia from any country in the world, no matter what their sex, colour, ethnic origin or religion, provided they meet objective visa criteria. These criteria generally relate to skills, age, business experience, facility with the English language and health.
i3 Pharma Resourcing was established in Australia six years ago and since that time has seen an increasing number of candidates moving from positions within clinical research, quality assurance, data management, regulatory affairs and medical information in the pharmaceutical/CRO/Biotech industries in Europe to take on positions within these fields in Australia. This movement has been supported by a growth in local clinical trials activity that has outstripped local supply.

Clinical Research in Australia
So, what is it really like working in Australia and how transferable are your skills?
What types of roles are available and what skills will you utilise?
Being trained in ICH-GCP will stand you in good stead, since all clinical trials are run to this standard. The quality, expertise and training of investigators in Australia are high. Sites that conduct a large number of clinical trials have dedicated study site co-ordinators (who sometimes call themselves data managers, research nurses and, occasionally, clinical research assistants/associates; so don’t be confused!)

So where to live?
Australia has a rapidly growing population of 20 million people with most living in the major cities in each state; clinical research is largely conducted in these cities. Australia is a vast continent: London to Moscow is less distance than Sydney to Perth! Most major pharma companies and CROs are based in the Sydney area, with others around Melbourne, making them the most attractive options for work. Brisbane has a growing biotechnology community, which might also be worth considering.
There are differences in working between Australia and Europe, which largely relate to many roles being within affiliate offices. You may find that you are no longer included in some decision-making; many decisions are made at the company head office, in Europe or the US. This can be frustrating if you have been previously involved in such decisions.

Regulations
The government authority regulating clinical trials is the Therapeutic Goods Administration (TGA), a division of the Department of Health & Ageing. Trials are managed and approved by the experimental Drugs Section of the Drug Safety and Evaluation branch of the TGA. A Trans-Tasman Therapeutic Products Agency will be coming into operation in the future, although the proposed date for this has recently been delayed until July 2006.
Regulatory and ethics processes are quite similar to their UK counterparts, although some differences make the Australian processes simpler. There are two systems for gaining clinical trial approval in Australia: the Clinical Trial Notification Scheme and the Clinical Trial Exemption Scheme. The decision on which scheme to use for a specific study is usually made by the Sponsor; however, the Human Research Ethics Committee (HREC) may have some influence on this decision.

The Clinical Trial Notification scheme (CTN) is used for almost all trials (>99% in 2001). Under this system, the responsibility for examining the safety and toxicity of the agent, in addition to the ethical content of the study, is placed on a HREC. The majority of HRECs in Australia will approve Phase III and IV studies under the CTN scheme without issue. Negotiations may be required to have Phase I and II studies approved under this scheme, particularly if limited pre-clinical information is available. The study can proceed at that site once the CTN form is submitted to the TGA; the sponsor is not obliged to delay the start of the study pending TGA’s acknowledgment letter, although this is advisable. TGA acknowledgement is usually received within 10 days of submission of the CTN form.

The Clinical Trial Exemption Scheme (CTX) is similar to the CTX system that operated in the UK until May 2004, but is rarely used.

Roles
CRA/Project management
The most common role within Australian clinical research is that of a Clinical Research Associate (CRA). This is quite similar to a CRA role in Europe. There are quite a few Senior CRA and Project Manager roles, although higher-level roles, such as Clinical Research Manager, are less common due to the smaller market size.
A CRA can also be known as a Study Monitor, Clinical Research Scientist, or Site Manager. As you gain more experience, you could be given additional responsibilities, such as site or study management, project coordination, budgeting, timeline estimation and presenting at investigator meetings. Upon reaching Senior CRA or Project Leader level, your time spent monitoring will decrease as the additional responsibilities fill your day.
Some of the differences that have been noted by professionals who previously worked overseas in clinical research include:

CRAs in Australia are not often involved in designing protocols or CRFs, or report writing, with these activities usually managed in the overseas head office
The geographical area covered by a CRA is vast, with travel throughout Australia and New Zealand sometimes taking as much as 60% of the working week. This can mean long days with early flights and late returns
Project management usually focuses on local regions (e.g., Australia, and possibly New Zealand and/or Asia). A strategic global project management role is harder to find; however, this may change with the increasing number of biotechnology companies with head offices in Australia

Data management
The overseas Head Office often handles data management, although there are a few companies with local data management departments. As a result of this, there are fewer data management roles offering career development beyond a coordination role.

Drug safety/pharmacovigilance
This role may also be handled by the overseas Head Office or within a clinical or medical information department. However, there are quite a few companies with local Drug safety/pharmacovigilance departments.

Health economics
Australia is renowned for its leadership in Health Economics. Health Outcomes and Health Economics play a vital part in the planning and preparation of clinical and economic evaluations, registration of the product and product listing and pricing within Australia. The work involves collating information, such as for a Pharmaceutical Benefits Advisory Committee (PBAC) submission, and providing economic evaluations into the clinical protocols, new indications etc.

Medical affairs
The role of a Medical Affairs Associate (MAA), involves answering queries and conducting literature searches, and may also involve training representatives and reviewing/approving marketing material. Individuals seeking a position within Medical Affairs will need to ensure you have an understanding of Medicines Australia Code of Conduct. MAA generally have a pharmacy or pharmacology degree.

Regulatory affairs
The Therapeutics Goods Administration (TGA), Australia’s regulatory body, accepts both a Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) for the conduct of clinical trials. Although the CTN is the most common and popular route, the Regulatory Affairs Department is involved in determining the best strategy for the product.
A Regulatory Affairs Associate (RAA) coordinates regulatory matters between the company and the regulatory bodies, such as the TGA. RAA’s are predominantly involved in collating and writing information. They may be involved with regulatory authorities overseas such as New Zealand and Asia Pacific countries. Often the Head Office puts the total regulatory strategy together; however, the Australian office often will provide input into the Asia Pacific regulatory strategy.

Life in Australia
The reasons given by our sample group of i3 pharma resourcing sponsored employees for moving to Australia centre around lifestyle issues - weather, friends and the need for change:

“I wanted a new challenge and to experience life in a country with a better climate”
“The weather! No language barrier. Experiencing another culture.”
“ … a new experience, … friends that had previously made the move were all very happy.”
Did they find this? The things they say they particularly enjoy echo the same theme: sun, weather, beaches, outdoor lifestyle, quality of life, friendly people, etc. That is not to say that you don’t work hard in Australia; in fact, feedback received is that Australians work very hard and hours are generally quite long. According to one CRA, it is a “….myth that Australians don’t work as hard – I have never worked harder.”

However, with all the positives there are some downsides. Missing family and friends goes without saying, but some other little things that are missed too include:

• ‘Marmite’
• “Proper” chocolate
• English pubs
• Oxford Street clothes shops
• ‘Coronation Street’ (on TV in Australia, but many years behind)

Taking the plunge!

The overwhelming advice from your fellow Brits and Europeans who have taken the plunge is to “Do it now!”. Visa applications require lots of paperwork, so bring the essential documentation, get good advice on tax implications and understand the cost of private health insurance when you are on a sponsorship visa. Take the chance – you have nothing to lose as you can always go back. You have lots to gain – from experiencing a new culture to being able to live in one of the best (if not the best) countries in the world.
Be willing to take the chance to come out without a job lined up – you will sometimes find the interview process will start before you arrive, but a decision is generally not made until they meet you face to face. Provided you have done your research, and are realistic regarding opportunities and salaries, the average time to secure a role is between 4 weeks to 8 weeks.
Many people from the UK/Europe have taken this route. Here’s what they have to say:

KW: “ i3 gave me advice about living and working in Australia including a lot of practical details. They made sure I was ok, both in my personal life and at my secondment company. Supported my application for a business visa and have continued to be there for help and socialising ever since!!!!”

CS: “i3 were fabulous. They gave me open, honest advice about what it is like to live in Oz and what you miss from home. They helped not only with finding a job, but also with meeting others in the industry, organising accommodation and a car, arranging my visa.... the list goes on! I am not sure I would have survived without their support and help!"

You already enjoy the benefits of the Institute to Clinical Research in the UK. The Australian Regulatory & Clinical Scientists (ARCS) is the Australian equivalent and information can be found at www.arcs.com.au

Other useful websites:
www.tga.gov.au Therapeutic Goods Administration
www.jtaproject.com Trans-Tasman Therapeutic Products Agency Project
www.acdm.org.uk Association of Clinical Data Management
www.ama.com.au Australian Medical Association
www.amc.org.au Australian Medical Council
www.asmr.org.au Australian Society of Medical Research
www.health.gov.au/tga Therapeutics Goods Administration
www.mja.com.au Medical Journal of Australia
www.medicinesaustralia.com.au Medicines Australia
www.psa.org.au Pharmaceutical Society of Australia
www.visabureau.co.uk/australia The Australian Visa Bureau assists British and Irish nationals obtain a visa to help them successfully enter Australia
www.immi.gov.au Government web site about who can work in Australia.

Paula Mumby (paula.mumby@i3pharmaresourcing.com) is Director, Australia, i3 Pharma Resourcing and Iain Jessup (iain.jessup@i3pharmaresourcing.com) is Director, UK & Ireland, i3 Pharma Resourcing.

Ready to give your career a bounce?
Follow us Down Under.

Interested in advancing your career while adding some adventure to your personal life? i3 Pharma Resourcing can make it happen. With offices in Sydney and Melbourne, i3 has the size and reach to offer you exciting opportunities across a wide range of Australian companies.

We now have diverse openings for clinical research, medical information, data management and regulatory affairs professionals with 12 or more months’ experience.

Joining the i3 team would allow you to discover the great nation of Australia, a land of extremes. Australia is home to a vast number of things that can kill you—the world’s ten most poisonous snakes, the great white shark, the box jellyfish and toxic spiders, to name just a few—but it is also a country of extreme beauty. Numerous white sandy beaches, wide-open spaces and tropical forests are yours to explore, as are one-of-a-kind destinations like Sydney Harbour, Kakadu and the Great Barrier Reef. You’ll also find a wide range of animals not seen anywhere else on Earth, such as the kangaroo, platypus and koala. We benefit from a high standard of living in Australia, too, where it’s common to relax with friends over a glass of wine from one of our many fine wineries, or a cold beer with a great meal. We’re also home to thriving, culturally diverse cities, are sports crazy and enjoy plenty of sunshine—what’s not to like?

For further information on our Australia-based opportunities, visa requirements and working conditions, as well as i3 careers based in the UK, please email ben.sherlock@i3pharmaresourcing.com or call us at +44 (0) 1628 408 560.
www.i3PharmaResourcing.com