Temporary Pharmaceutical Non-Clinical Subject Matter Expert

Initial 2-month contract (part time average 15 hours per week) offering £70 p/h

One of the worlds largest and most innovative medical manufacturers has an urgent requirement for a Temporary Pharmaceutical Non-Clinical Subject Matter Expert

Qualifications:

* Ph.D. with at least 5 years of experience in pharma non-clinical studies or
* Master's degree with at least 8 years of experience or
* Equivalent combination of education and experience
* Advanced knowledge in the design, execution, and assessment of studies in the following areas
Pharmacodynamics (PD): Primary and secondary PD, safety PD, and PD drug interactions
Pharmacokinetics (PK): Absorption, Distribution, Metabolism, Excretion, PK drug interactions
Toxicology: Single-dose toxicity, Repeat-dose toxicity, Genotoxicity, Carcinogenicity, Reproductive and developmental toxicity, and Local Tolerance

* Ability to perform literature searches for relevant publications
* Ability to read, analyze and interpret common scientific and technical journals
* Ability to summarize complex non-clinical reports clearly and concisely

Project tasks

Search the available literature for relevant non-clinical studies

• * Assess relevant non-clinical studies (internal and literature studies) for applicability to Iruxol
  * Determine the information to be presented in the appropriate pharma dossier section and provide strong, scientific rationale for the determination
  * Align non-clinical dossier sections with clinical dossier sections in collaboration with the clinical subject matter expert
  * Review pharma dossier non-clinical sections in collaboration with a medical writer and other team members