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.
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.
This role will be remote, reporting to our clients site in Watford.
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
- 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
Quote job ref 49311.
It is essential that applicants hold entitlement to work in the UK.
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- Agency: CK Group
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: 49311
- Updated: 20th November 2020
- Expires: 18th December 2020