ARDEM Data Services | Medical Data Analyst | eluru

Job Description

Overview

A Medical Feedback Reviewer focuses on assessing and providing feedback on various medical documents and communications to ensure their quality, accuracy, and compliance with regulatory standards. Here are the roles and responsibilities for this position:

Roles and Responsibilities

1. Document Review:

• Review a wide range of medical documents, including clinical trial reports, regulatory submissions, patient records, research papers, and medical communications.
• Ensure documents are accurate, clear, complete, and free of errors.

2. Feedback Provision:

• Provide detailed and constructive feedback on the content, structure, and clarity of medical documents.
• Identify and correct any inconsistencies, discrepancies, or inaccuracies.
• Suggest improvements to enhance document quality and readability.

3. Quality Assurance:

• Ensure all reviewed documents meet internal quality standards and external regulatory requirements.
• Verify the inclusion of all necessary information and adherence to the required format and style.

4. Regulatory Compliance:

• Ensure that documents comply with relevant regulations and guidelines, such as those from the FDA, EMA, ICH, and GCP.
• Stay updated on changes in regulations and guidelines and incorporate these into the review process.

5. Collaboration:

• Work closely with medical writers, researchers, regulatory affairs specialists, and other stakeholders to ensure high-quality document preparation.
• Participate in meetings and discussions related to document development and review.

Required Skills and Qualifications:

• Educational Background: A degree in life sciences, medicine, pharmacy, or a related field. 
• Experience: Previous experience in medical writing, regulatory affairs, clinical research, or a related area.
• Attention to Detail: Strong attention to detail and ability to identify errors and inconsistencies.
• Communication Skills: Excellent written and verbal communication skills.
• Regulatory Knowledge: Familiarity with relevant regulations and guidelines.
• Analytical Skills: Strong analytical and critical thinking skills.
• Collaboration: Ability to work effectively in a team 
• Time Management: Good organizational and time management skills to handle multiple documents and deadlines.
• This role is essential in ensuring that medical documents are accurate, high-quality, and compliant with regulatory standards, thereby supporting the credibility and integrity of medical information and communications.

Additional Requirements

This opportunity enhances your work life balance with allowance for remote work. To be successful your computer hardware and internet must meet these minimum requirements:

• Laptop or Desktop:

• Operating System: Windows
• Screen Size: 14 Inches
• Screen Resolution: FHD (1920×1080)
• Processor: I5 or higher
• RAM: Minimum 8GB (Must)
• Type: Windows Laptop
• Software: AnyDesk
• Internet Speed: 100 MBPS or higher

About ARDEM:

ARDEM is a leading Business Process Outsourcing and Business Process Automation Service provider. For over twenty years ARDEM has successfully delivered business process outsourcing and business process automation services to our clients in USA and Canada. We are growing rapidly. We are constantly innovating to become a better service provider for our customers. We continuously strive for excellence to become the Best Business Process Outsourcing and Business Process Automation company.