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SABR Associate Jobs

Cambridge, Massachusetts
<p>Job Title:SABR Associate (Sr. Associate II, Quality and Compliance, Trial Master File)Job Duration: 5 monthsJob Location:Cambridge, MAPOSITION SUMMARYThis position will liaise and collaborate with others in the Quality and Compliance department in order to complete their tasks of performing completeness and document quality reviews of SABR Trial Master File (TMF) deliverables.ESSENTIAL JOB FUNCTIONS1. Implement and maintain SABR compliance with Client's Global Record Management requirementsa. Support tracking of the authoritative source(s) for PV informationb. Perform maintenance activities for SABR archival strategy and resource plan2. Implement SABR TMF documentation quality strategy to meet GCP & GVP regulationsa. Perform Document Quality Reviewb. Perform Completeness Reviewc. Complete activities for inspection readiness of SABR TMF documentation3. Support Audit and Inspection activities as required QUALIFICATIONSEducationB.A. or B.S. degree or equivalent required, science degree preferredExperience Minimum 3 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences highly desired Knowledge of FDA Post-marketing and Clinical Trial Pharmacovigilance regulations is required Direct experience in GCP compliant quality systems Regulatory affairs, quality assurance or clinical departments experience is preferred Familiarity with ARISG and TrackWise is preferred.Skills The employee must have working knowledge of pharmaceutical R&D regulatory affairs and drug safety knowledge. This position requires the employee to work with moderate direction and allows the employee the ability to exercise some latitude in determining their approach to completing work assignments. Candidate should have strong organizational skills and be able to pay attention to detail.</p>
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