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CMC - Subject Matter Expert Consultant

United States   •  $160 per hour  •  Contract/Temporary, Part time

Expertise: Clinical SME of live biotechnology product
Scope: The client would like us to support on the  US IND for their compound- SK10 (an inactive bacteria), a product to be used jointly with cancer treatment, intending to ease treatment side effect.
The clinical SME would be required to guide the clinical writer to write the briefing document and meeting request letter required for the pre-IND meeting request application, to optimize the possibility of getting useful feedback from FDA. The clinical SME would also need to be able to attend the FDA meeting (if granted), and be able to interpret FDA responses and guide client to the next step of IND application.           
Cap on hours: 40
Start Date: Immediately
End Date: March 2022
Required Effort: Total of 40 hours until end of Mar 2022
Location: North America
On site/Off Site: Off site

  • Agency: Achieva Group Limited
  • Contact: Lewis Coulson
  • Phone: 01727 811 634
  • Reference: BH-32609
  • Posted: 18th November 2021
  • Expires: 16th December 2021

Achieva Group Limited

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