Senior/Principal Medical Editor – FSP (Regulatory Documents)
About The Position
Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs. In this role, you will collaborate with passionate problem solvers in a Functional Service Provider partnership or a Full-Service environment, innovating as a team to help customers achieve their goals. The company is agile and driven to deliver for its colleagues, customers, and patients. Syneos Health is committed to developing its people through career development, training, and recognition, and fostering an inclusive culture where employees can be authentic. The purpose 'Driven to Deliver' captures the passion of colleagues to shape solutions that can dramatically impact lives. The company is continuously building a workplace that employees want to be a part of and customers want to work with, believing that bringing together diverse colleagues can shape the future of healthcare and drive progress for patients.
Requirements
- Strong familiarity with FDA, EU, and other relevant guidelines and industry standards.
- Experience in medical writing or editorial roles.
- Ability to represent the editorial group in medical writing, on study teams, and in cross-departmental project teams.
- Skills in monitoring timelines and budgets.
- Ability to provide technical support and expertise.
- Experience in training and mentoring medical editing staff.
- Advising on quality review, compilation, and editorial standards.
- Experience in leading complex and/or large medical writing projects.
- Ability to schedule and lead internal project-specific team meetings.
- Experience in organizing project-specific requirements.
- Ability to ensure information is distributed to the editorial team and implemented within the deliverable.
- Experience as a member of a medical writing team.
- Ability to provide feedback on the editorial process.
- Proficiency in copyediting, applying correct grammar, punctuation, spelling, and style.
- Knowledge of AMA Manual of Style or various custom style guidelines.
- Familiarity with established medical writing internal checklists and best practices.
- Ability to perform quality review of documents to ensure accuracy.
- Contribution to process improvement tools and development/revision of internal policies and procedures.
- Management of assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
- Experience in compiling medical writing deliverables.
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.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
