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Clinical Editor

hace 2 meses

Madrid, Madrid, España Syneos Health 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

We bring 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.

Our Culture

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

Job Responsibilities

The Clinical Editor will be responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide. This includes copyediting/proofreading, formatting, and verifying data content in clinical documents in accordance with company SOPs and processes to ensure documents meet required standards.

  • 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

We are looking for a highly skilled Clinical Editor with:

  • 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.