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Clinical Editor

2 months ago

Québec, Quebec, Canada Syneos Health Full time
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.

Job Responsibilities
  • 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 budgets for assigned projects 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.
  • Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards.
Qualifications
  • Bachelor's degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience.
  • Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred.
  • 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.
  • 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.
  • Must have previous QC of clinical documents experience gained within a CRO or Pharmaceutical company.
  • 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.