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Regulatory Affairs Associate

Job Attributes

Job Id:

25348

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

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.

 

Responsibilities 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 $50,000 based on meeting of requirements
  • Benefits: Health, Dental, & Vision insurance and 401K

 

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

 

Keywords:

Good Clinical Practice, GCP, IRB, institutional review board, FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, regulatory affairs, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, tmf, database management programs, analytical tools, CTMS, trial master file, data management, quality assurance, human safety, specialist, clinical operations, management, standard operating procedures, protocols, sop, skillset, leadership, human resources, medical, dental, vision, 401k, 401(k), paid time off, benefits, Clinical Research, Regulatory Affairs, Clinical Research organization, Clinical Research Organization, CRO, research trials, clinical research trials, medical, md, Maryland, bachelor degree, bachelor of science, science 

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Job Id:

25348

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

No Clearance

Business Unit:

Piper Companies