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

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

Updated: Yesterday

Location: Morrisville, NC, United States

Job :-OTHLOC-1500-2

DRI-2DR

• 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, editors, and study teams on quality review, compilation, and editorial standards; provides training to the global medical writing team in relevant aspects.
• Serves as 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 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 the 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 - $

• A company car or car allowance
• Health benefits including Medical, Dental and Vision
• Company match 401(k)
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time

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.

Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.