Senior/Principal Medical Editor – FSP, Regulatory Documents

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Maintains a strong understanding of FDA, EU, and other pertinent guidelines and industry standards to guarantee that documents meet or surpass sponsor and regulatory requirements and guidance.

• Acts as a representative of the editorial group in medical writing, on study teams, and in cross-departmental project teams as necessary.

• Oversees timelines and budgets for assigned projects, updating the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk.

• Provides technical support and expertise as needed. Trains medical editing staff and serves as a mentor. Offers guidance to medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Delivers training to members of the global medical writing team regarding their roles.

• Acts as the project lead for deliverables of assigned complex and/or large medical writing projects, including scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is communicated to the editorial team and incorporated within the deliverable.

• Participates as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on the progress of the editorial process.

• Edits assigned documents for correct grammar, punctuation, spelling, and style in accordance with the AMA Manual of Style or various custom style guidelines, as well as established medical writing internal checklists and best practices.

• Conducts quality reviews of assigned documents to ensure accuracy.

• Contributes to the creation of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.

• Manages assigned projects in compliance with medical writing standard operating procedures and client standards, ensuring timely and budget-friendly delivery.

⛳️ Requirements

• Maintains a robust familiarity with FDA, EU, and other relevant guidelines and industry standards.

• Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as required.

• Monitors timelines and budgets for assigned projects.

• Provides technical support and expertise as needed.

• Conducts training for medical editing staff and serves as a mentor.

• Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards.

• Acts as the project lead for deliverables of assigned complex and/or large medical writing projects.

• Edits assigned documents for proper grammar, punctuation, spelling, and style in line with the AMA Manual of Style or various custom style guidelines.

• Conducts quality reviews of assigned documents to ensure precision.

• Manages assigned projects according to medical writing standard operating procedures and client standards.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision coverage.

• Company match for 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on company and individual performance.

• Flexible paid time off (PTO) and sick leave.