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Subject Matter Expert (part time)

Watford, Hertfordshire, United Kingdom, £ £ - Annual Annual, Contract


Subject Matter Expert required for our global medical devices client based in Watford. This role is fully remote and can be based anywhere in the UK. This role is also a part time role.

• 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
o Pharmacodynamics (PD): Primary and secondary PD, safety PD, and PD drug interactions
o Pharmacokinetics (PK): Absorption, Distribution, Metabolism, Excretion, PK drug interactions
o 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, with reference to the pharma eCTD Module 4 and Sections 2.4 and 2.6

• 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

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert

Job Details

Not Specified
Watford, Hertfordshire, United Kingdom
£ £ - Annual Annual