
Leading Medical Document Specialist
1 day ago
We are seeking a highly skilled Senior Medical Editor to join our team, responsible for ensuring the quality, accuracy, and compliance of medical documents.
- Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
- Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
- Monitors timelines and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
- Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor.
- Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable.
- Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process.
- Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices.
- Performs data integrity review of assigned documents to ensure accuracy.
Key Qualifications
- Bachelor's degree in life sciences, clinical sciences, English/journalism, copyediting, data integrity review, or relevant publishing experience.
- Significant relevant publishing experience using Adobe Acrobat or other markup language preferred; ISIToolbox experience preferred.
- Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Excellent attention to detail, strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills.
- Extensive familiarity with AMA style guide strongly preferred.
- Ability to work with minimal supervision on multiple assignments with set deadlines.
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