Non-clinical Subject Matter Expert

CK Group are recruiting for a Part Time Non-clinical Subject Matter Expert to join a global medical technology company in the pharmaceutical industry on a contract basis initially for 2 months. The role is 100% home based and will be approximately 10-20 hours per week.

Company:
Our client takes a pioneering approach to the design of advanced medical products and services, holding lead positions in Orthopaedics Reconstruction, Wound Management and Sports Medicine.

Location:
This role will be remote, reporting to our clients site in Watford.

Rates:
£44.42 PAYE
£58.77 LTD

Role:
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)
• 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

Your Background:

• PhD 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


Apply:
Quote job ref 49311.

It is essential that applicants hold entitlement to work in the UK.