Overview
Senior Medical Editor - Regulatory (EMEA Home Based)
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers on the customer and the patient. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers and work to accelerate the delivery of therapies.
WORK HERE MATTERS EVERYWHERE
Discover what our 29,000 employees across 110 countries already know. Learn more about Syneos Health at http://www.syneoshealth.com
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 coordinating internal meetings, organizing requirements, and ensuring information is distributed to the editorial team and implemented within the deliverable.
* 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.
* Performs copyediting and quality review of documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or client-specific guidelines.
About Syneos Health
We are a global biopharma solutions organization committed to developing our people through career development and training, with supportive management and a culture that values diversity and inclusion.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. All language is intended to comply with applicable laws and reflect our commitment to equality and reasonable accommodations where appropriate.
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Marketing, Public Relations, and Writing/Editing
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