FSP Essential Document Pack Reviewer

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Assess essential documents from countries for completeness, precision, and quality in line with the Essential Document Compliance checklist.

• Evaluate essential documents from sites for completeness, precision, and quality in accordance with the Essential Document Compliance checklist.

• Inform the EDP Submitter via email about the outcomes of reviews, required revisions, and corrected documents when issues are found.

• Review updated packs to ensure that identified issues have been addressed and communicate the review results to the SSU Specialist.

• Monitor EDP review information in the relevant data tracking system.

• Stay updated on SOPs, client-specific SOPs/directives, and current regulatory guidelines.

⛳️ Requirements

• A Bachelor's degree or relevant experience equivalent to 2+ years.

• Strong written and verbal communication skills in English, as well as proficiency in the local language where necessary.

• Excellent attention to detail, quality assessment, editorial, and proofreading abilities.

• Strong interpersonal skills for effective collaboration within a team.

• Proficient in computer software, including Microsoft Word, Excel, and PowerPoint, with the capability to adapt to new technologies.

• Basic skills in organization, time management, and planning.

• Competent negotiation skills.

• Ability to work autonomously under guidance and utilize independent judgment.

• Capability to evaluate sponsor regulatory requirements and produce compliant deliverables alongside project team members.

• Fundamental understanding of global, regional, and national requirements and regulatory procedures for clinical trial authorization, licensing, and lifecycle management.

• Basic knowledge of medical terminology, statistical concepts, and applicable guidelines.

• Strong analytical, investigative, and problem-solving capabilities.

• Ability to interpret data effectively.

🏝️ Benefits

• Competitive salary package.

• Opportunities for professional development and growth.

• Inclusive workplace culture.

• Flexible working arrangements.