This role as a Medical Data Analyst at ARDEM Data Services is a full-time, entry-level remote position that focuses on reviewing medical documents and ensuring they meet quality, regulatory, and accuracy standards. This role is essential for maintaining high standards in medical documentation, such as clinical trial reports, regulatory submissions, and patient records, which supports the credibility of ARDEM’s services.
Key Responsibilities
- Document Review:
- Review diverse medical documents, ensuring they are clear, complete, and accurate.
- Feedback and Quality Assurance:
- Provide constructive feedback, identify inconsistencies, and suggest improvements for readability and accuracy.
- Verify adherence to internal and regulatory quality standards.
- Regulatory Compliance:
- Ensure compliance with FDA, EMA, ICH, and GCP guidelines and stay updated on changes in regulations.
- Collaboration:
- Work closely with medical writers, regulatory affairs specialists, and other team members to enhance document quality.
Required Skills and Qualifications
- Education: Degree in Life Sciences, Medicine, Pharmacy, or a related field.
- Experience: Background in medical writing, regulatory affairs, or clinical research is a plus.
- Skills:
- Strong attention to detail, analytical abilities, and proficiency in written and verbal communication.
- Knowledge of regulatory guidelines and ability to work well in a team.
- Good time management to handle multiple documents and deadlines.
Technical Requirements
- Windows OS laptop/desktop with an i5 processor or higher, 8GB RAM, FHD screen, and 100 MBPS internet speed.
How to Position Yourself as a Strong Candidate
To make a strong case for this role:
- Highlight your familiarity with regulatory standards and experience in document review, even if from academic or internship projects.
- Emphasize attention to detail and any experience you have with compliance or accuracy in documentation.
- Demonstrate strong communication skills and your ability to collaborate effectively with cross-functional teams, particularly in document-intensive settings.
