Principal Medical Content Specialist

3 days ago

Mumbai Kolkata Delhi, India beBeeSeniorMedicalEditor Full time

Job Title: Senior Medical Editor

Description

We are seeking a proactive and experienced Senior Medical Editor to join our team, responsible for ensuring the quality, accuracy, and compliance of medical documents. The ideal candidate will have extensive experience in copyediting, data integrity review, and project management within the medical writing field.

This role involves acting as a subject matter expert, mentoring staff, and leading projects to ensure deliverables meet all sponsor and regulatory requirements. The successful candidate will be highly proficient in Microsoft Office Suite (Word, Excel, and PowerPoint) and have excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem-solving, organizational, interpersonal, presentation, project management, and team-oriented skills.

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.
  • 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.
  • 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.
Required Skills and 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.
  • 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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