Dear members,
The Norwegian Medicines Agency (NOMA) is currently seeking a scientist/senior
advisor with advanced skills in pharmacometrics. NoMA is part of the European
Regulatory Network as one of the National Competent Authorities (NCAs). The
European Medicines agency (EMA) coordinates the regulatory activities in Europe
and NoMA closely collaborates both with EMA and other NCAs. We are now looking
for a consummate team player seeking a collaborative environment in which to
grow their career in the regulatory assessment of new drugs and in advising
industry on drug development. https://legemiddelverket.no/English
Responsibilities:
* Assessing the credibility of pharmacometric models submitted for
applications for marketing authorisation for medicinal products, new
indications, paediatric developments, clinical trial applications as well as
scientific advice
* Assess the results of the dose-response, population PK and PK/PD and/or
PBPK model in relation to conditions of use such as dosing regimens,
extrapolation approaches or other aspects related to a medicinal product
* Scientific advice meetings with the pharmaceutical industry and academia
* Other relevant tasks at the Agency
Requirements:
* A university degree (MSc or PhD) in pharmacokinetics, pharmacology,
pharmacometrics, statistics, biostatistics, mathematics or, alternatively,
other health scientific degree with documented competence in pharmacometrics.
* Previous experience with one or several of the following modelling
approaches
* Pop- PK/PD
* PBPK
* QSP
* Experience applying pharmacometrics through medical product development
is an advantage.
* Good written and oral communication skills in English
* Knowledge of the pharmaceutical legal framework is an advantage
The successful candidate will have the following skills:
· Analytical, systematic and effective
· Initiative, diplomatic and of good judgement
· Well developed interpersonal skills and team player
· Ability to deliver procedures and processes within deadlines
· Precision in execution of work with attention to details
If you are interested, please send your CV to
[email protected]<mailto:[email protected]> or give me a call +
47 99048481
Thanks,
Seline Knüttel-Gustavsen
Best Regards,
Seline Gustavsen
Head of Unit, Market Authorisation Assessment and Scientific Advice
Telephone: +47 99048481
www.noma.no<http://legemiddelverket.no/english>
[cid:[email protected]]<http://>
