Senior Medical Editor, Regulatory

🕒 il y a 10 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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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 and guidance. • Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed. • 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.

🎯 Exigences

• 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. • 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.

🏖️ Avantages

• Total Self culture – where you can authentically be yourself • Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program