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Regulatory Affairs Specialist

Job Attributes

Job Id:

18126

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

Not Defined

Business Unit:

Piper Companies

JOB DESCRIPTION

Responsibilities for the Regulatory Affairs Specialist:

  • Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms, annual reports, IND applications, IDE applications, and summary reports
  • Regulatory correspondence with PI’s and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates
  • Prepare investigator/pharmaceutical company meeting minutes
  • Analyze preclinical/clinical research data, perform literature searches and extract information to support regulatory documents and prepare reports on findings
  • Maintain TMF related to ongoing studies and all regulatory documentation
  • Update, review, and maintain electronic databases for clinical trials

 

Requirements for the Regulatory Affairs Specialist: 

  • 3+ years of experience managing and submitting regulatory documentation for clinical trials (IRB/GCP/FDA)
  • Advanced knowledge of medical terminology
  • Working knowledge of database management programs, analytical tools, and
  • Ph.D. in science-related field preferred, Master’s Degree accepted

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Job Id:

18126

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

Not Defined

Business Unit:

Piper Companies