Sr Medical Editor

We are seeking a highly skilled Sr. Medical Editor to ensure the quality and accuracy of medical writing deliverables. This role involves strict adherence to regulatory guidelines, managing project timelines and budgets, and providing technical expertise to both the editorial and medical writing teams. The ideal candidate will possess excellent attention to detail, strong project management skills, and a deep understanding of medical editing standards.

Roles & Responsibilities

• Quality & Compliance Oversight:
• Maintain familiarity with FDA, EU, and other relevant guidelines to ensure documents meet or exceed regulatory requirements.
• Perform data integrity review of assigned documents to ensure accuracy.
• Copyedit documents, applying correct grammar, punctuation, spelling, and style following the AMA (American Medical Association) style guide or other custom guidelines.
• Project & Team Leadership:
• Act as a project lead for complex and large medical writing projects.
• Monitor timelines and budgets for assigned projects, updating relevant stakeholders if deliverables are at risk.
• Serve as a mentor, providing technical support and training to medical editing staff.
• Advise medical writers and study teams on data integrity review, compilation, and editorial standards.
• Collaboration & Process Improvement:
• Represent the editorial group on study teams and cross-departmental project teams.
• Collaborate with the medical writing team and provide feedback on the progress of the editorial process.
• Contribute to the development of process improvement tools and the revision of internal policies affecting editorial work.
• May be responsible for compiling and publishing medical writing deliverables.

Qualifications

• A Bachelor's degree (preferred) in the life sciences, clinical sciences, English/journalism, or relevant copyediting experience.
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Excellent attention to detail, along with strong copyediting, data integrity review, and problem-solving skills.
• Excellent grammatical and communication skills, both written and oral.
• Extensive familiarity with the AMA style guide is strongly preferred.
• Proven ability to work independently with minimal supervision on multiple assignments with set deadlines.
• Experience with publishing software like Adobe Acrobat and ISIToolbox is a plus.
• Knowledge of FDA, EU, and ICH regulations as applicable to regulatory documents is preferred.