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Research Medical Writer

Job Attributes

Job Id:

34205

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20877

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Clinical Solutions is seeking motivated Research Medical Writer professionals in Bethesda, MD to support an established clinical research company with the preparation of regulatory and scientific documents to support clinical research trials.  

 

Responsibilities for the Research Medical Writer:

·       Develop scientific and regulatory documents including: Investigational New Drug (IND) applications, preclinical and clinical study reports, safety reports, and investigator brochures for submission to the Food and Drug Administration (FDA) or Institutional Review Board (IRB)

·       Perform literature searches and assist in the development of protocols (SOP)

·       Analyze medical research data to prepare study findings and reports

·       Responsible for preparing meeting minute reports for high-level internal and external stakeholder engagements

·       Prepare safety documents related to CAPA and SAE’s

·       Assist in the development of technical proposals and manage client communication

 

Requirements for the Research Medical Writer:

·       1+ year of Medical Writing experience related to protocol development, study reports, regulatory documentation, dissertations, etc

·       Knowledge of IRB and FDA regulations, medical terminology, and analysis of medical research data

·       Ph.D., PharmD, MD, or Master’s Degree in Scientific Field

 

Compensation for the Research Medical Writer:

·       Salary Range up to $75,000 based on years of relevant experience

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

 

 

Keywords:

CRO, Clinical research organization, clinical trials, pharmaceutical, biotechnology, biotech, gcp, good clinical practices, qms, quality management system, quality management plans, cqms, sop, standard operating procedures, protocol, medical writer, medical writing, science writing, SOP, standard operating procedures, FDA, clinical study reports, safety reports, investigator brochure, literature search, data analysis, medical terminology

·        

·       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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New Search

Job Id:

34205

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20877

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions