Sr. Medical Editor (Regulatory Documents + QC) - US Home based

Job Responsibilities

• Maintains strong 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.
• Performs QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents).
• Verifies data in documents against the source tables, figures, and listings and formats tables.
• Makes sure timelines and budgets for assigned projects are monitored and updated as necessary.
• 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 quality review, compilation, and editorial standards.
• Provides training to members of the global medical writing team in aspects relative to their roles.
• Serves as 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 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 editorial process.
• Copies edits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices.
• Performs quality review of assigned documents to ensure accuracy.
• Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
• Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
• May compile medical writing deliverables.

Qualifications

Required:

• Bachelor’s degree in a related field (e.g., biomedical science, biochemistry, molecular biology, etc.)
• Minimum of 5 years of experience in medical writing, regulatory affairs, or a related field
• Strong understanding of FDA, EU, and other relevant guidelines and industry standards
• Experience with document management and quality assurance processes
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple projects simultaneously

Preferred:

• Master’s degree in a related field
• Experience with regulatory submissions and compliance
• Knowledge of medical writing standards and best practices
• Experience with medical writing software and tools