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

Syneos Health

1d • Remote

About The Position

Syneos Health is a leading fully-integrated life sciences services organization dedicated to accelerating customer success in drug development and commercialization. The Clinical Solutions team leverages extensive experience and deep expertise to understand customer needs and shape effective solutions. The company is committed to developing its people through career progression, supportive management, technical and therapeutic area training, peer recognition, and a total rewards program. Syneos Health fosters an inclusive culture, driven by a purpose to deliver solutions that impact lives. The organization continuously strives to be a desirable workplace for both employees and customers, believing that diverse talent can shape the future of healthcare and accelerate patient progress. This Senior Medical Editor role is crucial in ensuring regulatory documents meet or exceed sponsor and regulatory requirements, involving quality control, project leadership, and training.

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.
• Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents).
• Verify data in documents against the source tables, figures, and listings and format 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.
• Copyedits 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.

Benefits

• company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed