Discovery Life Sciences is a leading provider of human biospecimens and cellular starting materials for advancing cell and gene therapy. They are seeking motivated interns to join their Regulatory team, providing hands-on experience in regulatory compliance and quality systems, assisting in gap assessments, regulatory research, and documentation.
Responsibilities
- Perform gap analyses for applicable regulatory requirements, ISO standards, and guidelines
- Identify areas for improvement and document findings
- Assist in evaluating changes to regulatory requirements impacting the Tissue Biomarker Services sites (US and EU)
- Prepare summaries and reports for management review meetings related to regulatory requirements
- Compile a list of applicable local regulations for each site
- Create and maintain a comprehensive database of regulatory requirements for: GCLP (Good Clinical Laboratory Practice), ISO 17020, Other relevant standards and guidelines
- Assist in preparing Institutional Review Board (IRB) annual reports and related documents
Skills
- Interest in regulatory compliance and quality systems in the biotechnology industry
- Strong attention to detail and organizational skills
- Ability to conduct research and interpret complex concepts
- Proficient in Microsoft Office Suite (Excel, Word, PowerPoint)
- Excellent written and verbal communication skills
- Currently enrolled in a Bachelor's or Master's program in life sciences preferred or other related fields such as legal may be considered
- Some prior experience with Smartsheet would be beneficial
Company Overview
Discovery Life Sciences, the Biospecimen and Biomarker Specialists™, is a leading provider of highly characterized human biospecimens and cellular starting materials integrated with expert multi-omic analytical services to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. It was founded in 2006, and is headquartered in Huntsville, Alabama, USA, with a workforce of 501-1000 employees. Its website is http://www.conversantbio.com/.
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