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Regulatory Affairs Associate

Job Attributes

Job Id:

19378

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20815

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is looking for a motivated Regulatory Associate to join an established Research Organization’s regulatory team in Bethesda, MD.  The Associate will be involved protocol adherence within supported clinical trials.

 

Job Description for the Regulatory Affairs Associate:

  • Prepare standard documentation supporting regulatory filings
  • Maintain files for regulatory documents using trial master files
  • Maintain and update  electronic databases for clinical trials
  • Develop and maintain Standard Operating Procedures and Work Instructions
  • Provide administrative support and other duties as assigned
  • Use knowledge of GCP protocol

 

Requirements for the Regulatory Affairs Associate:

  • Experience using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred
  • Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable
  • General knowledge of the drug development process or clinical trials
  • B.A./B.S. degree

 

 

Compensation for the Regulatory Affairs Associate:

  • Salary up to $45,000 based on meeting of requirements
  • Benefits: Health, Dental, & Vision insurance and 401K

 

Please send all qualified resumes to: idusci@pipercompanies.com

 

Keywords:

Good Clinical Practice, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, data management, tmf, trial master file, standard operating procedures, protocols, adherence, sop

 

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Job Id:

19378

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20815

Security Clearance:

No Clearance

Business Unit:

Piper Companies