Quality Medical Reviewer
1 week ago
The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
§ Know policies and procedures, and review promotional and medical (non-promotional) materialsThorough understanding of quality requirements and processes (i.e., CIQ and MCA requirements) and applying these guidelines consistently during the review process
Verify all data values match the source documentation such as references provided, and are also consistently used throughout the document sections, charts, legends, and footnotes
Verify visual representations of data accurately convey the meaning/results of the data
Ensure data represents current knowledge and published scientific data
Ensure information is presented in a clear, complete, accurate, and concise manner
Ensure key data, statements, and conclusions are consistent across related documents, and statements and conclusions are integrated, accurate, balanced and supported by appropriate data
Collaborate with cross-functional teams such as Marketing, Medical teams, etc. during the review, approval, and management of content, including attending review meetings as and when required
Demonstrate working knowledge of therapeutic areas, products and disease state information, and familiarity with trial designs, rationale, and data
Understand key priorities and communication strategies across therapeutic areas and/or organizational units
Expertise in tools and platforms such as Veeva Vault, project planning software (e.g., Wrike, MS Project), etc.
Required Skill:
Quality Medical Reviewer
- 10 years of experience in reviewing clinical documents from any pharma companies
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