Senior Medical Editor, Regulatory Documents, QC

🕒 April 23

🌵 Arizona, Maine, +3 more states – Remote

🌵 Arizona – Remote 🦞 Maine – Remote 🏖️ New Jersey – Remote 🏈 Ohio – Remote ⚓ Rhode Island – Remote

💵 $62k - $108.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements • Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed • Perform QC review of 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 if deliverables are at risk • Provides technical support and expertise as appropriate • Conducts training of medical editing staff and functions as a mentor • Serves as project lead for deliverables of assigned complex and/or large medical writing projects • Serves as a member of the medical writing team for projects with medical writing deliverables • Copyedits assigned documents • Performs quality review of assigned documents to ensure accuracy

🎯 Requirements

• Maintains strong 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 needed • Perform QC review of documents • Verify data in documents against the source tables, figures, and listings and format tables • Monitors timelines and budgets for assigned projects • 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 • Serves as project lead for deliverables of assigned complex and/or large medical writing projects • Serves as a member of the medical writing team for projects with medical writing deliverables • Copyedits assigned documents • Performs quality review of assigned documents to ensure accuracy • Contributes to the development of process improvement tools

🏖️ Benefits

• 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