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Scientific Evaluator

Position title
    
Scientific Evaluator – Canberra based role 

Start date

ASAP
    
End date
    
12 months from commencement with possible extension 
    
Location

This role will be based in our client’s office in Canberra 

Background information on Section and Branch

Branch: The Branch is responsible for approving applications to market biologicals and generic medicines in Australia. The Branch provides scientific advice to support the decisions made by the Medicines Regulation Division, evaluating the toxicological and pharmaceutical chemistry aspects of therapeutic products and providing expertise in the biological sciences.

The Section is responsible for

  • evaluation of quality aspects of biological medicines, including gene therapy, plasma derivatives and recombinant proteins
  • evaluation of quality and clinical aspects of biologicals, the authorisation of biologicals and administration of the regulatory framework for biologicals (human cells and tissues)
  • regulation of blood and blood components
  • evaluation of infectious disease safety aspects of therapeutic goods
  • regulatory assessments of cell and tissue therapy

Duties of position

Specific duties include:

  • Working in a small professional, specialist or technical team in evaluating applications for therapeutic goods that are, or contain, biological materials
  • Preparing and reviewing documents, including recommendations and reports for decisions by delegates
  • Contributing to the development of standards, guidance documents, standard operating procedures and other scientific and business processes to support on-going and business improvement activities
  • Providing accurate professional, specialist and/or technical advice on complex matters related to blood/biologicals/biological medicines/infectious disease safety
  • Contributing to strategic direction of the Section, including contributing to preparing and continually improving performance standards and business processes to better deliver outcomes
  • Maintaining and developing professional knowledge and awareness of current developments in blood/biological medicines/infectious disease safety/biologicals
  • Providing balanced input into decisions using professional judgement, expertise, knowledge and agency guidelines
  • Maintaining strong relationships with other internal staff and external stakeholders, including government agencies, representatives of industry and consumers
  • Represent the client in relation to activities of the Section at cross agency meetings, conferences and other forums.

Mandatory requirements

Candidates must be able to demonstrate:

  • A relevant qualification in biological sciences from an Australian tertiary institution, or comparable overseas qualifications. Postgraduate qualifications desirable.
  • Applicants must be willing to obtain a police check prior to commencement.

Desirable
    
Desirable skills and experience:

  • A sound knowledge of the regulatory framework for therapeutic goods in Australia, including applicable legislations, Standards and guidelines or demonstrated ability to rapidly learn and apply knowledge.
  • Scientific analytical ability demonstrated through work in a research, industry or regulatory environment;
  • Strong organisational and time management skills, and the ability to manage multiple tasks and manage other staff;
  • Good interpersonal, liaison and stakeholder management skills, including the ability to develop productive working relationships; and
  • Good written and oral communication skills.
If interested, please apply directly through the links provided. Alternately, contact Kalpana for more information.

  

Kalpana Palaniyappa
0403 200 666 
kalpana.palaniyappa@calleo.com.au 

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