Senior Medical Evaluator, Prescription Medicines

HorizonOne; Canberra; On-site; AUD 165,000 - 207,000; Full time

Benefits offered by this job

Free parking

Northside location

Job summary

HorizonOne Recruitment Pty is partnering with the Therapeutic Goods Administration (TGA) to recruit for a Medical Officer (Class 3) in the Prescription Medicines Authorisation Branch. The role involves reviewing complex clinical data and providing evidence-based recommendations to support regulatory decisions on medicines.

This is a 12-month labour hire contract with extension options, located on the Northside of Canberra with on-site free parking.

Qualifications

• Australian citizenship and medical practitioner registration required.
• Experience in health/regulatory environment desirable.
• Ability to gain knowledge of TGA frameworks, guidelines, and regulations.
• Strong written and verbal communication skills.

Responsibilities

• Support timely prescription medicine assessments and regulatory decision-making.
• Provide evidence-based recommendations to support ARTG registrations and variations.
• Collaborate with internal and external stakeholders in a small team.

Skills

Regulatory decision-making

Analytical evaluation

Written and oral communication

Stakeholder management

Education

Medical qualification (Medicine)

Job description

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

HorizonOne is committed to building a diverse and inclusive workforce and we encourage applications from people of all cultures, capabilities and backgrounds.