Senior Medical Editor, Regulatory Documents, QC

🕒 il y a 2 mois

🌵 Arizona, Maine, +3 états de plus – Distant

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

💵 $62 000 - $108 600 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

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Syneos Health

Site WebLinkedInTous les Emplois

10 000+ employés

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health est une organisation de solutions biopharmaceutiques entièrement intégrée et leader, conçue pour accélérer le succès des clients. Ils transforment des intuitions cliniques, des affaires médicales et commerciales uniques en résultats pour répondre aux réalités du marché moderne. En utilisant des technologies avancées et des perspectives, Syneos Health collabore avec les clients pour accélérer la livraison de thérapies importantes aux patients dans le monde entier, offrant des services qui couvrent tout le spectre du clinique au commercial.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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