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June

Medical Officer Class 4

National Health Funding Body - Symonston, ACT

Government, Defence & Emergency
Source: uWorkin

Source: uWorkin

JOB DESCRIPTION

Full Job Description
Job Reference Number 21-MRDIV-8632
Classification MEDOFF4
Job Title Medical Officer Class 4
Division Medicines Regulation Division
Branch Prescription Medicines Authority Branch
Section Clinical Evaluation Section
Location Symonston ACT, Parramatta NSW, Melbourne VIC
Status Ongoing
Employment type Full-time
Salary Range $161,184 - $177,416
Security Clearance Baseline (Protected, Highly Protected, Restricted, Confidential)
Mandatory Qualifications A degree in medicine from a recognised educational institution

and Australian Medical Registration
Desirable Qualifications • Post graduate tertiary qualifications in a related field

  • Fellowship of an Australian medical college, or working
towards Fellowship

Contact Officer Name: Dr Nitin Bagul
Phone: 02 6289 2194
Email: nitin.bagul@health.gov.au

Eligibility
To be eligible for employment with the Department of Health applicants must be an

Australian citizen at the time an offer of employment is made

An applicant’s suitability for employment with Health will also be assessed through a

variety of pre-employment check processes, such as:
Satisfactory completion of an Australian Federal Police criminal history check,

and where relevant a Working with Children and Vulnerable People Check.
Completion of a medical declaration and pre-employment medical (where

required).
Providing evidence of qualifications.

Division Responsibilities
The Medicines Regulation Division (MRD) is part of the Health Products Regulation Group
(HPRG) in the Department of Health. MRD undertakes evaluations of applications to
approve new medicines for supply in Australia. Senior Medical Officers in the MRD make
decisions to approve or reject market authorisation of medicines that are imported,
exported, manufactured and supplied in Australia and provide ongoing monitoring of
medicines approved for supply

Branch Responsibilities
The Prescription Medicines Authorisation Branch (PMAB) sits within the Medicines
Regulation Division (MRD) and is responsible for evaluating new chemical entity prescription
medicines, leading to an approval or rejection decision. Through evaluating the clinical
aspects of clinical medicines, PMAB ensures medicines available for supply in Australia are
safe, fit for their intended purpose and available in a timely manner. The branch also
approves clinical aspects of variations to registered medicines and participates in a number
of transparency initiatives.

Section Responsibilities
Medical officers in PMAB operate within different clinical units with overall responsibility for
market authorisation of medicines that fall within particular clinical groupings, such as
medicines to treat diseases of the endocrine, vascular systems or medicines to treat
infectious diseases or cancer. Medical officers review clinical evidence generated through
trials to determine the overall risk versus benefits of the product and act as decision makers
for the Therapeutic Goods ACT 1989.

Key Responsibilities
  • Work at an executive level standard with a high level of autonomy across a broad
scope of regulatory assessment, program responsibility and management;
  • Support the Director in the functioning and management of the section;
  • Lead and manage a small team of medical officers and clinical assessors;
  • Provide clinical advice to assist the development of policies and guidelines within
TGA's regulatory environment;
  • Provide training and support to other medical and professional officers on regulatory
science, clinical medicine, clinical pharmacology, or clinical epidemiology;
  • Contribute to the development and revision of technical and administrative
procedures and documentation within the Branch and TGA as a whole, including
contributing to new policy and work process reforms and on the adoption of
regulatory guidelines;

  • Effectively partner and collaborate with key external stakeholder groups;
  • Undertake assessment of clinical evidence to provide timely and high quality
decision making in regard to pre-market review of prescription medicines, including

where necessary identification of any areas of clinical uncertainty in medicine
applications;

  • Seek advice on matters of concern from TGA's specialist advisory committees; and
  • Coach and guide junior Medical Officers and pharmacists.
Key Capabilities
  • Have an understanding of, and preferably experience with, the Australian regulatory
requirements for therapeutic goods, or the ability to quickly develop this
understanding;

  • Demonstrate an understanding of organisational processes and legal and public
policy constraints;

  • Highly adept at effectively engaging and collaborating with stakeholders;
  • Be able to accurately interpret and convey complex clinical matters to diverse
  • stakeholders;
  • Have excellent judgement with the ability to take responsibility for decisions and
manage escalated matters;
  • Have well developed written and verbal communication skills with a great attention
to detail;
  • Be flexible and manage a varied workload within given timeframes
Desirable Experience
  • Post-graduate tertiary qualifications in a relevant field, eg. Public Health,
Epidemiology or management;
  • Fellowship of an Australian medical college, or working towards Fellowship;
  • Work experience in the medical technology or pharmaceutical industries;
  • Clinical research experience;
  • Familiarity with undertaking critical reviews of clinical research or trial data;
  • Academic practice;
  • Experience leading and supervising either medical practitioners or professional staff.
Application Response
Your application will be assessed on your ability to demonstrate that you possess, or have
the real potential to develop, the required skills, knowledge, experience and qualifications
to perform the role. These requirements are based on the information provided to you as
part of the job advertisement, in line with the APS Work Level Standards.

Applicants are required to provide a statement of claims framed around the key duties and
key capabilities. Your statement of claims should be no more than one page in total with a
font no smaller than size 10. Applications that do not meet these requirements may not
be considered.

Work Environment Description
Responsibilities - As detailed in Section 28 of the Work Health and Safety Act 2011 while at

work, a worker must:
  • Take reasonable care for his or her own health and safety
  • Take reasonable care that his or her acts or omissions do not adversely affect the
health and safety of other persons
  • Comply, so far as the worker is reasonably able, with any reasonable instruction that
is given by the person conducting the business or undertaking to allow the person to
comply with this Act

  • Cooperate with any reasonable policy or procedure of the person conducting the
business or undertaking relating to health or safety at the workplace that has been
notified to workers

  • Complete all WHS related induction and training
  • Report all work related incidents and/or illnesses to the WHS Section
Description Requirement Additional Information

Administrative

1. Computer Use Yes

2. Generic screen based Yes

3. Sitting at desk Yes

4. Standing for long periods No

Manual Handling

5. Lifting 0-15kg No

6. Lifting 15 kg + No

7. Climbing No

8. Bending No

9. Squatting No

10. Reaching No

11. Push/pull No

12. Sequential Repetitive No
Movements in short period of time

13. Manual dexterity/manipulation No

Work Environment

Description Requirement Additional Information

14. Work with others towards Yes
shared goals in a team environment

15. Works in isolation from other No
staff (remote supervision)

16. Distance walking (ie: Large Yes
building or inter-building transit)

17. Works outdoors No

18.Works in a call centre No
environment

19. Works in a customer service No
environment

Tasks Involving

20. Exposure to chemicals No

21. Exposure to biological hazards No

22. Working at heights No

23. Requirement to wear personal No
protective equipment (PPE)

24. Requirement for full Colour No
vision

25. Work with energetics and No
explosives

26. Exposure to Petrol, Oil, Lubricant No
Products that may cause
dermatological conditions

27. Exposure to extreme No
temperatures

28. Confined spaces No

29. Exposure to Non-ionising No
radiation

30. Excessive Noise No

31. Low Lighting No

Description Requirement Additional Information

32. Dangerous Goods/ Equipment No

33. Exposure to airborne odours No

Travel

34. Frequent travel - Vehicle No

35. Frequent travel - Aeroplane No

36. Frequent travel - Seaborne No

Cyclic Workload

37. Peaks & Troughs Yes

38. Frequent Overtime No

39. Rostered Shift Work No

Symonston, ACT

Government, Defence & Emergency




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