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Contract Medical Writer Jobs

Company

Clinical Staffing Insight (CSI)
Address United States
Employment type CONTRACTOR
Salary
Category Research Services,Pharmaceutical Manufacturing
Expires 2023-10-02
Posted at 8 months ago
Job Description

Contract Medical Writer (Regulatory)


Responsible for writing and editing clinical research documents according to SOPs and GCP/ICH guidelines. These documents describe the design and monitoring of clinical trials, analysis and evaluation of clinical data while ensuring compliance with quality standards for publication and reproducibility.


EXPERIENCE:


  • Able to provide input in Clinical Project Team meetings regarding implications of project decisions on Medical writing content and timelines
  • Able to review statistical analysis plans and clinical data reports to ensure consistent data reporting within a program and/or therapeutic area
  • Excellent organization and problem-solving skills
  • BS degree and at least 5 years of medical writing experience
  • Knowledge of FDA regulatory requirements, GCP/ICH guidelines, and general medical terminology
  • Experience writing clinical regulatory documents (protocols, CSRs, Investigator Brochures, Informed Consent Templates, Safety Narratives and clinical summary documents)