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Scientific Evaluator

Our client is responsible for the regulation of over-the-counter medicines as well as complementary medicines, which include traditional and herbal medicines, vitamin and mineral supplements, that are supplied in Australia to provide assurance that these medicines meet appropriate standards of quality, safety and efficacy consistent with their risk.
  
They undertake market authorisation and compliance activities including:

  • Post market compliance reviews of low-risk medicines.
  • Pre-market evaluations of registered over the counter and complementary medicines.
  • Assessment of new substances for use in listed medicines; and
  • Maintaining the listed medicines application portal for low risk listed medicines.

They are responsible for:

  • Evaluating the quality, safety and efficacy of registered complementary medicines.
  • Evaluating the quality and safety of new ingredients for use in listed complementary medicines.
  • Evaluating the efficacy of assessed listed medicines.
  • Liaising with stakeholders and sponsors in matters relating to the regulation of complementary medicines; and
  • Providing strategic input into regulatory reform projects relating to complementary medicines.  

Start date
ASAP
  
End date   
23 December 2022
  
Possibility of extension    
Yes  
  
Duties of position
       
Specific duties include:

  • Applying technical expertise to process and evaluate the efficacy, safety or quality of non-prescription medicines with reference to relevant legislation and regulations as well as established policies and practices for inclusion in the Australian Register of Therapeutic Goods (ARTG) – the primary duty is likely to be evaluating efficacy of medicines and as such, statistics training is highly desirable.
  • Providing assistance with, and drafting, technical and scientific recommendations and reports in relation to applications for the registration of new, or variations to existing, non-prescription medicines.
  • Preparing correspondence to industry based on the outcomes of reviews/evaluations and contribute to other relevant documents as required.
  • Liaising, engaging and collaborating with internal and external stakeholders on complex technical matters.
  • Planning and monitoring work flows and taking responsibility for the achievement of team outcomes.
  • Assisting with the streamlining of applications to ensure efficient processes within applicable timelines; and
  • Undertaking other tasks as required and directed.  

Mandatory requirements        
  
Selection criteria
  
Candidates must be able to demonstrate:

  • An ability to evaluate clinical trials
  • Scientific and analytical skills
  • Well-developed written and oral communication skills with experience in scientific writing.  

Desirable  

  • Understanding of statistics used in clinical trials
  • Experience in the evaluation and regulation of therapeutic goods.
  • Experience in the evaluation of bioequivalence data.

If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
  
Kalpana Palaniyappa
0403 200 666  
kalpana.palaniyappa@calleo.com.au 

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