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

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

Updated: Yesterday

Location: USA-CT-Client

Job :

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

Improves and ensures the quality of compliance of written deliverables through copyediting, quality review, and document management. Provides advanced editorial guidance and technical expertise in the writing, production, and/or review of regulatory and other scientific/clinical documents. Independently performs advanced quality review or compilation tasks for medical writing deliverables to ensure content integrity and consistency with customer and/or regulatory submission standards. Leads editorial team for large deliverables requiring multiple editors.

Interacts with medical writing leadership and staff regarding assigned deliverables as appropriate. Provides training and mentoring to other medical editing staff members.

• 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 (e.g., 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.
• 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; 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.
• Copy 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.

$62,000.00 - $

Benefits include a company car or car allowance, medical, dental, and vision coverage, company match 401k, employee stock purchase plan, commission or bonus eligibility based on company and individual performance, and flexible paid time off and sick time.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at