Senior Strategic Medical Writer - Remote

Added
6 minutes ago
Type
Full time
Salary
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Related skills

documentation gcp regulatory affairs biostatistics ich guidelines

πŸ“‹ Description

  • Prepares clinical and regulatory documents needed for the development of AbbVie drugs and/or
  • Functions with a moderate degree of autonomy on draft materials, but relies on review by subject
  • Coordinates the review, approval, and quality control of other functions involved in the production
  • Produces and maintains clinical and regulatory documents focusing on quality and compliance and
  • Develops knowledge of US and international regulations, requirements, and guidelines pertaining to
  • Participates in execution of tactical process improvements.

🎯 Requirements

  • A minimum of 4+ years of bio-pharmaceutical industry experience in global pharma, biotech, life
  • Bachelor's Degree or higher required; scientific discipline preferred.
  • Outstanding written and oral communication skills, with a comprehensive knowledge of medical and
  • Proficient in assimilating and analyzing complex data.
  • Experience writing and editing clinical and regulatory documents following guidelines and
  • Understanding of drug development, clinical research, study designs, biostatistics, pharmacology

🎁 Benefits

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick)
  • This job is eligible to participate in our long-term incentive programs.
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