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Regulatory Affairs Specialist

Job Attributes

Job Id:

17586

Job Category:

Clinical & Life Sciences

Job Location:

Philadelphia, PA  19104

Security Clearance:

No Clearance

Business Unit:

Zachary Piper Solutions

Division:

Zachary Piper LLC

JOB DESCRIPTION

 

Piper Companies is currently looking for a Regulatory Affairs Specialist  in Philadelphia, PA to support the clinical research unit within a Cancer center instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. 

This is a 6-12 month contract to hire opportunity. There are 2 openings.  

Responsibilities for the Regulatory Affairs Specialist Include:

  • Facilitate regulatory aspects of Phase I-V clinical trials with a focus on required regulatory start-up approvals & associated site initiation documentation
  • Prepare and process all initial oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA, etc
  • Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA
  • Oversee the development of investigator-initiated research protocols, the development and submission of FDA IND applications, and the development of study specific forms and source document tools
  •  

Qualifications for the Regulatory Affairs Specialist Include:

  • 2-4+ years experience supporting clinical trials
  • IRB submission experience required
  • 2+ years experience working with regulatory documentation
  • BS degree in healthcare administrations, life sciences, or related degree

Compensation for the Regulatory Affairs Specialist Includes:

  • $45-$50/hr on a contract rate
  • Full Benefits

Please send all qualified resumes to Karen Pallone at kkpallone@pipercompanies.com 

Apply Now

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Job Id:

17586

Job Category:

Clinical & Life Sciences

Job Location:

Philadelphia, PA  19104

Security Clearance:

No Clearance

Business Unit:

Zachary Piper Solutions

Division:

Zachary Piper LLC