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Principal/Sr Medical Editor - Regulatory Documents
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What they do
An Editor reviews stories, reports or manuscripts, makes corrections, and works with writers to improve content and structure of writing. Plans and coordinates material to be included in publications. Works with print material or website content. May specialize in copy editing (careful review of text for errors) or other types of editing; may work as an executive editor with authority to approve publications and contracts.
$65,351 / year median in the U.S.
-21% projected decline
Job Description
- Regulatory Documents
- Copy Editing + QC
- NA/Canada Remote Based Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture- where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives
- we're able to create a place where everyone feels like they belong. Job 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.
Salary Range:
$62,000.00- $108,600.