CANDIDATE INFORMATION
NATIONAL MANAGER
Therapeutic Goods Administration
(SES Band 3)
January 2012
Executive Search
THERAPEUTIC GOODS ADMINISTRATION
1. Background
The Therapeutic Goods Administration, which is a business unit of the Department of Health
and Ageing, is responsible for regulating prescription, over-the-counter and complementary
medicines, medical devices and manufacturers of therapeutic goods. It also monitors
incidents once products are on the market, and assesses the suitability of medicines and
medical devices for export from Australia. It does this through the application of the
Therapeutic Goods Act 1989 (the Act). The Act provides a national framework for the
regulation of therapeutic goods in Australia and outlines a risk based regulatory framework
for therapeutic goods where the level of regulation reflects the assessed risk of the
therapeutic good. Products on the market in Australia are required to be manufactured to
an appropriate quality, and must be safe to use as intended.
Essentially, the Act requires any product for which therapeutic claims are made to be
included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in
Australia. To include a therapeutic product on the ARTG, a supplier needs to apply to the
TGA including the required safety and efficacy information. The TGA will review the
application, with input from external experts if necessary, and then make a market
authorisation decision as to whether or not to al ow the product to be marketed. The TGA
then engages in ongoing post-marketing surveillance, inspection and investigation.
Higher risk products must demonstrate that they are effective in treating the conditions for
which they are approved; low risk products need only demonstrate that they are of an
acceptable quality and that they do not present significant safety risks.
The TGA carries out its regulatory activities consistent with the objectives of the Act and
provides advice to Ministers in relation to the operation of the current regulatory system for
therapeutic products, as wel as possible changes to the system to meet future needs of the
Australian population.
In administering the Act, the TGA fosters relationships with other governments and
government agencies, health professionals, consumers and the therapeutic goods industry.
The TGA has over 500 staff, with a diverse workforce including medical practitioners,
scientists, chemists, laboratory technicians, compliance auditors and investigators,
accountants, and lawyers, amongst a range of other roles.
The TGA aims to attract and retain skil ed staff and supports a culture of high performance,
continuous learning, and scientific excel ence through a focus on:
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THERAPEUTIC GOODS ADMINISTRATION
• effective leadership and management;
• a shared commitment to protecting the community; and
• being an employer of choice.
2. Mission
To safeguard public health in Australia through administration of a national framework for
the regulation of therapeutic products, which is consistent with international best practice
and ensures the timely availability of therapeutic products in Australia that are of good
quality and safe for their intended purpose.
3. Vision
To be recognised nationally and internationally as a best practice regulator of therapeutic
products with the confidence and respect of governments, the community and the
regulated industry.
4. Overview of Reforms within the TGA
The TGA commenced major internal reform in 2009-10 aimed at ensuring that it can meet
the expectations of the Australian community and deliver most effectively the functions
required of it by the Australian Government.
In July 2010, the TGA implemented new structural arrangements to separate its regulatory
functions into two groups: the
Market Authorisation Group (MAG), which manages the pre-
market assessment and authorisation of therapeutic products, and the
Monitoring and
Compliance Group (MCG), which monitors post-market performance of therapeutic
products. These regulatory activities are supported by the
Regulatory Support Group (RSG)
which is the TGA in-house regulatory support and corporate business unit.
This was the first major organisational restructure within the TGA since 1989 and wil
continue to facilitate the achievement of the key priorities outlined below. In 2011-12, the
TGA will undertake additional reforms, such as implementing the outcomes of the reviews
of:
• transparency;
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THERAPEUTIC GOODS ADMINISTRATION
• advertising;
• medical device regulation; and
• complementary medicine regulation.
In addition, the TGA will progress closer business to business regulatory arrangements with
the New Zealand regulator, Medsafe.
5. Key Priorities
The TGA’s key priorities have been developed in response to emerging expectations of the
role of therapeutic goods regulation around the world, mindful of the needs of the
Australian health system and community in the 21st century.
The TGA’s six key priorities are:
1. Increase the Australian community's understanding of our regulatory processes and
decisions so as to enhance the public trust in the safety and quality of therapeutic goods.
2. Take action to ensure that the objectives of the Therapeutic Goods Act continue to be
met through an effective regulatory framework.
3. Ensure the robustness and consistency of regulatory decision-making and record keeping
across the organisation.
4. Advance the application of regulatory science to ensure it is capable of meeting the
challenges of new product development, emerging safety issues and changing
community needs and expectations.
5. Enhance our business processes to achieve greater efficiency and predictability for
handling applications for market authorisation in order to ensure timely access to
therapeutic goods for the community.
6. Ensure that the application of our resources matches the level of risk associated with
both the type of products regulated and the regulatory risk associated with our pre and
post-market oversight of those products.
Each priority is underpinned by strategies, TGA projects and activities that support the
organisation’s ongoing regulatory activities.
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THERAPEUTIC GOODS ADMINISTRATION
6. TGA Organisational Structure
The TGA regulatory offices consist of three core groups:
1. The
Market Authorisation Group is responsible for the evaluation and authorisation of
therapeutic goods to ensure they meet appropriate standards of quality, safety and
efficacy or performance, consistent with their risk.
2. The
Monitoring and Compliance Group is responsible for monitoring of therapeutic
goods on the Australian market to ensure that they comply with required standards of
quality, safety, efficacy and performance.
3. The
Regulatory Support Group provides the business systems and support services that
enable the TGA to undertake its regulatory responsibilities.
An organisation chart that details the offices within these groups follows.
For further information please visit the TGA website: http://www.tga.gov.au
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THE POSITION AND THE PERSON
Title:
National Manager
Reports to:
Secretary, Department of Health and Ageing
Location:
Canberra
1.
Position Overview
As National Manager of the TGA, you will report to the Secretary of the Department of
Health and Ageing and assume overall responsibility for the leadership, strategic direction
and governance of this high profile federal government agency with more than 600 people
and $100m plus annual cost recovery-funded budget. You wil oversee implementation of
recently announced
TGA reforms: A blueprint for TGA’s future, and ensure the TGA
enhances current policies and processes to continue to adapt with flexibility and agility to
new scientific developments and emerging community expectations. You wil also play a
key role in the creation of an Australia-New Zealand international regulatory agency which
involves significant senior national and international engagement.
2.
Relevant Experience
To be a strong contender, you wil need to be an outstanding leader and manager with
well-honed policy advisory and resource management skills and a proven record of
achievement as a senior executive, ideally gained in a large, complex and operationally
diverse health care, regulatory or other professional organisation. You will have
exceptional communication and representational skills, proven capacity to drive change,
and a demonstrated ability to engage senior stakeholders and broker decisions through
collaboration.
3.
Managerial and Personal Attributes
The appointee wil be expected to:
• Possess a high level of professional and personal integrity.
• Demonstrate sound judgement and a balanced and professional approach when
providing strategic policy advice.
• Have wel developed presentation and representational skil s and the ability to
communicate effectively with both lay and professional audiences.
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THE POSITION AND THE PERSON
• Be articulate and persuasive and capable of guiding negotiations to a point of
resolution in a facilitative way.
• Be capable of engendering loyalty and respect and generating a high level of
commitment from staff within the TGA.
• Have the drive, energy and enthusiasm necessary to make a major contribution
within the Heath and Ageing portfolio.
4.
Qualifications
Appropriate tertiary qualifications will be well regarded.
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SELECTION CRITERIA
The criteria below are applied when selecting for Senior Executive Service (SES) positions
within the Australia Public Service (APS). When considering applicants, Selection Advisory
Panels will seek evidence of performance against each of the criteria. SES selection panels
may use a range of methods to identify work outcomes, capabilities and behaviours that
demonstrate performance. It is therefore in the interests of candidates to present their
application in a way that demonstrates significant outcomes associated with each of the
criteria, as well as the capabilities and behaviours that underpin them. (Please note that it is
not necessary to address the capabilities and behaviours individually.)
1
Shape Strategic Thinking
Relevant capabilities and behaviours:
• inspires a sense of purpose and direction
• strategic focus
• ability to recognise opportunities, harness information
• shows judgement, intel igence and common sense
2
Achieve Results
Relevant capabilities and behaviours:
• organisational capability
• professional expertise
• implements change
• ability to clarify ambiguities
• closure and delivery
3
Exemplify Personal Drive and Integrity
Relevant capabilities and behaviours:
• professionalism and probity
• risk-taking and personal courage
• action orientation
• resilience
• self awareness
• commitment to personal development
4
Cultivate Productive Working Relationships
Relevant capabilities and behaviours:
• nurtures internal and external relationships
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SELECTION CRITERIA
• facilitates co-operation and partnerships
• values differences and diversity
• guides, mentors and develops people
5
Communicate with Influence
Relevant capabilities and behaviours:
• communicates clearly
• listens, understands and adapts to different audiences
• negotiates persuasively
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REMUNERATION, TENURE AND CONDITIONS
1.
Remuneration
A senior executive package which reflects the importance of the position wil be negotiated
with the successful candidate, comprising:
• salary and performance bonus;
• superannuation;
• an executive vehicle cash-out allowance; and
• non-cash benefits (which could include parking, airport lounge membership, laptop
and mobile phone).
2.
Tenure
The successful candidate wil be offered ongoing employment.
3.
Eligibility
To be employed by the Department of Health and Ageing applicants
must be Australian
citizens or have permanent residency status pending the granting of Australian citizenship.
This is a position of trust and the successful candidate wil be subject to a security clearance.
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HOW TO APPLY
Applications should consist of:
1. a brief covering letter;
2. details of relevant skills, knowledge and experience in terms of the selection criteria;
and
3. a Curriculum Vitae setting out relevant personal particulars, employment history,
qualifications and experience.
The preferred method of submission of applications is by email in
Word format to:
Please note:
It is our standard practice to acknowledge the receipt of all applications. All applications are
acknowledged by return email asap (usual y within a few minutes on a weekday).
Applicants who do not have access to email should forward their applications to:
PO Box
If further information is required, please call
on
Applications close on 13 February 2012
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