SEND CDISC- Pre-clinical with Toxicology

Location: Montreal, Canada, QC
Date Posted: 12-18-2017
  • 5-6 years of experience of Toxicology, preclinical and CDISC-SEND in life science industry
  • Demonstrate effective communication skills (written and oral)
 
  • (For Sr. / Lead)Project planning and management.
 
Key Skills / Knowledge:
  • Good understanding of various toxicological studies and their principles
  • Capability of interpretation of results and analysis of key toxicity data, dose calculation/conversion
  • Knowledge of OECD/FDA/EPA guidelines for preclinical toxicity studies
  • Having understanding of toxicology studies (in silico, in vitro and in vivo)
  • Knowledge of various toxicology/ pharmacology/ clinical/ regulatory databases like TOXNET, ECOTOX, PubMed, e-Chemportal, clinicaltrails.gov, EFSA etc.
  • Basic knowledge of eco/environmental toxicity (e.g. biodegradation, toxicity to daphnia, fish (acute and chronic), toxicity to algae)
  • The ability to plan, execute, monitor and interpret toxicology studies
  • Able to work cross-functional teams to coordinate and manage pre-clinical activities
  • These activities also include the development of nonclinical sections for IND, IB, and NDA submissions as well as interactions with regulatory agencies.
  • Operational expertise in CDISC SEND Operations and Quality Checks
  • Knowledge/experience nonclinical data collection, analysis, and reporting in drug development and pre-clinical study processes
  • Good interpersonal skills and communication (both written and verbal) skills


At least a bachelor’s degree in Computer Science, Engineering or related field or an equivalent in education is required for this position.
We are an Equal Opportunity Employer.
 Thiru Varatha | AVP - PS | Technosoft Corporation | One Towne Square, Suite #600, Southfield, MI 48076 | www.technosoftcorp.com |
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