Quality Control Reviewer/Editor

  • location: Cambridge, MA
  • type: Contract
  • salary: $35 - $41 per hour
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job description

Quality Control Reviewer/Editor

job summary:
Our client is looking to add to a growing team for the TMF team. Gain great experience in a Top Pharma company.

location: Cambridge, Massachusetts
job type: Contract
salary: $35 - 41 per hour
work hours: 8 to 4
education: Bachelors
  • Liaise and collaborate with members of the SABR team (Stereotactic Ablative Body Radiotherapy) and other Client functions to manage the Safety Trial Master File (TMF).
  • Maintains activities for SABR paper TMF archival strategy. Supports Document Quality and Completeness Review. Ensures oversight for inspection readiness of SABR TMF documentation.
  • Updates Safety collection templates and forms as needed.
  • Requires B.A. or B.S. degree or equivalent experience desired, science degree preferred.
  • 3 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences highly desired.
  • Knowledge of FDA expectations is essential.
  • Knowledge of Post-marketing and Clinical Trial Pharmacovigilance regulations.
  • Direct experience in GCP compliant quality systems and data management.
  • Regulatory affairs, quality assurance or clinical departments experience is preferred.
  • Understanding of Lean Six Sigma process principles.
skills: Quality control, GCP (Good Clinical Practice), TMF
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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