Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy8xc3qtzxhly3v0axzll2pwzy9iyw5uzxitzgvmyxvsdc5qcgcixv0

Temporary Pharmaceutical Non-Clinical Subject Matter Expert

Temporary Pharmaceutical Non-Clinical Subject Matter Expert

  • Location

    Watford, Hertfordshire

  • Sector:

    Supply Chain

  • Job type:

    Contract

  • Salary:

    £60 - £70 per hour

  • Contact:

    Jamie Mackinlay

  • Contact email:

    jamie.mackinlay@1st-executive.com

  • Job ref:

    J13366_1605869130

  • Published:

    5 days ago

  • Expiry date:

    2020-12-20

  • Startdate:

    ASAP

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