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Urgent! Core ICF Developer/Writer and Reviewer (Centralized role) Job Opening In Bogotá – Now Hiring Fortrea

Core ICF Developer/Writer and Reviewer (Centralized role)



Job description

Core ICF Developer/Writer and Reviewer (Centralized role)

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Responsibilities:

  • Develop, review, finalize, and maintain clinical trial documents such as informed consent forms.

  • Apply knowledge of GCP Guidelines, regulatory requirements, privacy standards, biological samples standards, therapeutic areas, and IMPs to review and develop ICFs.
  • Ensure the content of the Master ICF aligns with the protocol and fully informs potential research subjects.

  • Write/edit documents in compliance with global industry standards and client-specific guidance.

  • Support development, review, and approval of master templates for protocol/site activation.

  • Create and revise training materials and plans.

  • Communicate effectively with stakeholders, including liaising with PM/Designee regarding trends, issues, or safety concerns.

Skills:

  • Strong knowledge of drug development process and FDA IND/NDA requirements.

  • Understanding of clinical trial regulations including FDA, GDPR, and GCP.

  • Knowledge of medical terminology and health literacy principles is a plus.

  • Proficiency in MS Word and excellent communication skills.

  • Ability to influence, plan, prioritize, and mentor.

Requirements:

  • University/College Degree (medical degree preferred).

  • 5+ years experience in writing and editing clinical trial documents.

  • Advanced English skills.

  • Strong knowledge of ICH-GCP and applicable regulations.

Seniority level: Mid-Senior level.

Employment type: Full-time.

Job function: Engineering and Information Technology.

This job posting is active.

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Required Skill Profession

Desarrollo De Software



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