CORE ICF DEVELOPER/WRITER AND REVIEWER (CENTRALIZED ROLE)

80.000.000 - 120.000.000
Fortrea


Core ICF Developer/Writer and Reviewer (Centralized role) Join or sign in to find your next job at Fortrea . 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. #J-18808-Ljbffr

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