Senior Medical Editor

hace 1 semana

Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completo
About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Job Responsibilities
  • Regulatory Compliance
    • 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.
  • Team Collaboration
    • Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
  • Project Management
    • Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
  • Technical Expertise
    • Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles.
  • 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
    • 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.
  • Process Improvement
    • Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
  • Project Execution
    • Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
  • Document Publishing
    • May compile and publish medical writing deliverables.
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.
    • Excellent grammatical and communication skills, both written and oral.
    • Extensive familiarity with the AMA style guide strongly preferred.
  • Personal Qualities
    • 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.

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