Senior Medical Editor, Regulatory Documents, QC

🕒 vor 1 Monat

🌵 Arizona, Maine, +3 weitere Bundesländer – Remote

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

💵 $62.000 - $108.600 / Jahr

⏰ Vollzeit

🟠 Senior

🚔 Compliance

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Syneos Health

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10.000+ Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health ist eine führende, vollständig integrierte biopharmazeutische Lösungsorganisation, die darauf ausgelegt ist, den Erfolg ihrer Kunden zu beschleunigen. Sie übersetzen einzigartige klinische, medizinische und kommerzielle Erkenntnisse in Ergebnisse, um den Anforderungen des modernen Marktes gerecht zu werden. Durch die Nutzung fortschrittlicher Technologien und Erkenntnisse arbeitet Syneos Health mit Kunden zusammen, um die Bereitstellung wichtiger Therapien für Patienten weltweit zu beschleunigen, und bietet Dienstleistungen, die das gesamte Spektrum von der klinischen Entwicklung bis zur Kommerzialisierung abdecken.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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