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
- 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.