Regulatory Affairs Specialist

20 Mar, 2021

Jobs

Regulatory Affairs Specialist

Piper Companies
Bethesda, MD

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 all Trial Mastery Files related to current studies

·       Update, review, and maintain electronic databases for clinical trials

 

Requirements for the Regulatory Affairs Specialist: 

·       1+ 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 CTMS

·       Ph.D. or Masters (3+ years of experience) in science-related field

 

Compensation for the Regulatory Affairs Specialist:

·       Salary up to $75,000 based on experience

·       Benefits: Health, Dental, & Vision insurance and 401K

 Learn more here

 

Job posted: 2021-03-20