Medical Document Quality Specialist
3 days ago
At ARDEM Data Services, we are seeking a highly skilled Medical Document Quality Specialist to join our team. This is a remote opportunity with a competitive estimated salary of $65,000 - $85,000 per year, depending on location and experience.
About the Role:
The Medical Document Quality Specialist will be responsible for assessing and providing feedback on various medical documents and communications to ensure their quality, accuracy, and compliance with regulatory standards. This includes reviewing clinical trial reports, regulatory submissions, patient records, research papers, and medical communications. The ideal candidate will have a strong attention to detail, excellent written and verbal communication skills, and familiarity with relevant regulations and guidelines.
Key Responsibilities:
- Document Review: Review a wide range of medical documents, ensuring they are accurate, clear, complete, and free of errors.
- Feedback Provision: Provide detailed and constructive feedback on the content, structure, and clarity of medical documents, identifying and correcting any inconsistencies, discrepancies, or inaccuracies.
- Quality Assurance: Ensure all reviewed documents meet internal quality standards and external regulatory requirements, verifying the inclusion of all necessary information and adherence to the required format and style.
- Regulatory Compliance: Ensure that documents comply with relevant regulations and guidelines, staying updated on changes in regulations and guidelines and incorporating these into the review process.
Requirements:
- 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.
What We Offer:
- A competitive estimated salary of $65,000 - $85,000 per year, depending on location and experience.
- Opportunity to work remotely.
- Required computer hardware and internet must meet minimum specifications: Windows operating system, 14-inch screen, FHD (1920×1080) resolution, I5 or higher processor, minimum 8GB RAM, AnyDesk software, and 100 MBPS or higher internet speed.
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