Medical Writer

1 month, 1 week ago
Full-time
Mid Level
Technical Writing and Documentation
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986

Description

  • Lead content planning and production of regulatory documents, including protocols, investigator brochures, clinical study reports, and informed consent forms.
  • Research, write, review, edit, and proof scientific content, data, tables, figures, exhibits, and appendices.
  • Coordinate document reviews and specialized content contributions with authors, scientists, investigators, and technical specialists.
  • Manage writing deliverables, track project timelines, and provide progress reports to stakeholders.
  • Conduct reference searches and verify citations.
  • Serve as liaison with external publication executives, illustrators, designers, and editors.
  • Perform quality control reviews of documents prepared by other authors when requested.
  • Review and edit study documents and templates, including charters, informed consent forms, and study plans.
  • Assist with developing and reviewing training materials and work instructions.

Requirements

  • Undergraduate degree required; advanced degree preferred.
  • 3–5 years of relevant medical writing experience.
  • Experience leading development of protocols, informed consent forms, and clinical study reports.
  • Training in GCP, GDPR, and HIPAA.
  • Advanced knowledge of EndNote or reference-management software.
  • Strong written and oral communication skills.
  • Ability to adapt to shifting priorities and assignments.
  • Demonstrated diplomacy and tact when working with stakeholders.
  • Familiarity with graphical software and figure development preferred.
  • Gastroenterology experience or knowledge preferred.
  • Familiarity with ICH M11 and the AMA Style Guide preferred.
  • Continuous improvement mindset and willingness to adopt appropriate new technologies.

Interested in this position?

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