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Medical Editor

hace 2 meses


Madrid Centro, Madrid, España Syneos Health, Inc. A tiempo completo
About Syneos Health, Inc.

Syneos Health, Inc. is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes.

Job Summary

We are seeking a highly skilled Medical Editor to join our team. As a Medical Editor, you will be responsible for maintaining familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.

Key Responsibilities
  • Regulatory Compliance: Maintain familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
  • Team Representation: Represent the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
  • Project Management: Monitor timelines and budgets for assigned projects and update the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
  • Technical Support: Provide technical support and expertise as appropriate. Conduct training of medical editing staff and functions as a mentor. Advise medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards.
  • Project Leadership: 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.
  • Document Review: Copyedit 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.
  • Data Integrity: Perform data integrity review of assigned documents to ensure accuracy.
  • Process Improvement: Contribute to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
  • Project Execution: Manage assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
Requirements
  • Education: Bachelor's degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience.
  • Experience: Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred.
  • Skills: Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills.
  • Knowledge: Extensive familiarity with the AMA style guide strongly preferred. Ability to work with minimal supervision on multiple assignments with set deadlines. Ability to work independently as well as part of a team and keep others informed of the progress and status of projects. Adaptable to changes in work duties, responsibilities, and requirements. Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.