Medical Editor and Regulatory Document Specialist

2 days ago

Gurgaon, Haryana, India beBeeSeniorEditor Full time US$ 1,34,055 - US$ 1,65,176

Job Title: Senior Medical Editor

We are seeking a highly skilled medical professional to lead our editorial team. The successful candidate will be responsible for editing and reviewing regulatory documents, ensuring compliance with sponsor and regulatory requirements.

About the Role:

This is an exciting opportunity to work on various projects, including clinical study protocols, clinical study reports, Investigator's Brochures, and Module 2 clinical summary documents.

Key Responsibilities:

  1. 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.
  2. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
  3. 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.
  4. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor.
  5. 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.
  6. Copies 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.
  7. Performs data integrity review of assigned documents to ensure accuracy.
  8. Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
  9. Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.

Requirements:

  • Bachelor's degree in life sciences, clinical sciences, English/journalism or copyediting, data integrity review, and/or relevant publishing experience.
  • Strong working knowledge of the editorial and publishing activities within Clinical Development, performing editing and Data QC review of regulatory documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents, etc.) to ensure compliance with the Sponsor Style Guide and submission standards and publication documents like manuscripts, posters and abstracts.
  • 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.
  • 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.

About Syneos Health:

Syneos Health has worked with novel drugs and therapeutic areas, contributing to advancements in healthcare.

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