Non-clinical Subject Matter Expert

  • Salary: £44.42 PAYE or £58.77 LTD
  • REF Number: 00049311
  • Consultant: Lucy Stendall
  • Contact: 01438 870011
  • Date Published: 20.11.2020
  • Closed Date: 27.11.2020
  • Sector: Non-Specific
  • Location: Home based, Home/Field Based, South East
  • Discipline: Scientific Advisor

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-dosetoxicity, Repeat-dose toxicity, Genotoxicity, Carcinogenicity, Reproductive and developmental toxicity, and Local Tolerance

Apply: For more information or to apply for this position, please contact Lucy Stendall on 01438 870011 or email pharmacontracts@ckagroup.co.uk, quoting job ref 49311.

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

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