Medical Editor Focus in Quality Control

hace 4 semanas

Edo de México Syneos Health Clinical A tiempo completo

**Description**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**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 SUMMARY**
**Improves and ensures the quality of compliance or written deliverables through copyediting, data integrity**
**review, document management, and publishing support. Provides advanced editorial guidance and**
**technical expertise in the writing, production, review, compilation, and publishing of regulatory and other**
**scientific/clinical documents. May independently perform advanced quality review, compilation, or**
**publishing tasks for medical writing deliverables to ensure content integrity and consistency with customer**
**and/or regulatory submission standards. Leads editorial team for large deliverables requiring multiple**
**editors. Interacts with department heads and staff members throughout the company regarding assigned**
**deliverables as appropriate. Provides training and mentoring to other Medical Editing staff members.**

**JOB RESPONSIBILITIES**
**Maintains 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 data**
**integrity review, compilation, publishing, and editorial standards. Provides training to members of the**
**global Medical Writing team in aspects relative to their roles.**
**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 projectspecific**
**requirements, and ensuring that 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 document editorial process.**

**American Medical Association (AMA) or various custom style guidelines as well as established**
**medical writing internal checklists and best practices.**
**Performs data integrity 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 and publish medical writing deliverables.**

**Qualifications**

**Get to know Syneos Health**

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us

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