Senior Medical Evaluator, Prescription Medicines

HorizonOne Recruitment · Braddon ACT 2612 · Full time
Posted 9d ago

Senior Medical Evaluator, Prescription Medicines

HorizonOne Recruitment
Braddon ACT 2612

·

Full time

~$237k - $296k(Estimated)
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KEY POINTS WE FOUND
  • Evaluate complex clinical data and evidence submitted for prescription medicine applications and variations.
  • Provide clinical and scientific advice and prepare evidence-based recommendations for regulatory decisions.
  • Apply medical expertise and sound judgement while managing deadlines and working with internal and external stakeholders.

Apply your medical expertise to assess new medicines and shape regulatory decisions that impact Australians' access to treatment.

About Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) are Australia’s government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods.

They regulate medicines, medical devices and biologicals to help Australians stay healthy and safe.

The Opportunity

The Prescription Medicines Authorisation Branch (PMAB) is responsible for processing and evaluating applications for new prescription medicines, new uses of prescription medicines and other variations to prescription medicines currently registered in the Australian Register of Therapeutic Goods (ARTG).

The Medical Officer (Class 3) is responsible for undertaking critical evaluations of complex clinical data and evidence submitted in support of prescription medicine applications.

The role provides clinical and scientific advice and prepares evidence-based recommendations to support regulatory decision-making regarding the registration and variation of prescription medicines on the Australian Register of Therapeutic Goods (ARTG).

  • 12-month labour hire contract with extension options
  • Opportunity to transition into the Commonwealth Government
  • Northside location – free parking on site for staff

The Role

Support timely prescription medicine assessments, uphold regulatory decision-making and help Australians access safe, effective, high-quality medicines.

Working in a small team, your role will be varied, interesting and fast-paced. No day will be the same.

The Ideal Person

You must be an Australian Citizen and hold a qualification in Medicine and be registered as a medical practitioner with the Australian Health Practitioner Regulation Agency to be considered.

Experience working within a health, regulatory or scientific environment, preferably in medicines regulation would be highly desirable, but is not essential.

You will also need:

  • The ability to gain an in-depth knowledge of TGA’s legislative and administrative frameworks, decision-making processes, guidelines and regulations
  • Capability to make balanced and informed decisions using evaluation and analytical skills, as well professional judgement
  • Well-developed written and oral communications skills
  • Excellent organisational and time management skills, with demonstrated ability to prioritise tasks and manage competing priorities and deadlines
  • Demonstrated ability to form strong working relationships with internal and external stakeholders
  • Ability to adapt, solve problems and assist with implementing new systems and processes

Salary / Rate

  • $120/hr – $150/hr + Super
  • Northside location
  • Free parking
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Skills

0 of 15 matched
AdaptableAnalytical thinkingClinical data analysisClinical evidence assessmentMedical judgementMedicines regulationOral communicationPrescription medicines evaluationProblem solvingRegulatory decision-makingRegulatory frameworksStakeholder managementTask prioritisationTime managementWritten communication

Licenses & certifications

0 of 2 matched
Medical qualificationRegistration as a medical practitioner with the australian health practitioner regulation agency (ahpra)

Perks & benefits

0 of 2 matched
Free on-site parkingOpportunity to transition into commonwealth government

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