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Sr medical editor (quality)

JR Spain
Editor
Publicada el 1 agosto
Descripción

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Senior Medical Editor

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 places the customer and patient at the center of everything we do. We continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and to make us better employers.

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 about changing 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, progression, supportive line management, training, peer recognition, and total rewards.
* We are committed to our Total Self culture, where you can authentically be yourself. Our culture unites us globally, and we are dedicated to caring for our people.
* We continuously build the company we all want to work for and that our customers want to work with, fostering diversity of thoughts, backgrounds, cultures, and perspectives.


Job Responsibilities

* Maintain familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure documents meet or exceed sponsor and regulatory requirements.
* Represent the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
* Monitor timelines and budgets for assigned projects, updating relevant stakeholders if deliverables are at risk.
* Provide technical support and expertise; conduct training and mentorship for medical editing staff.
* Lead projects for complex or large medical writing deliverables, organizing meetings, requirements, and ensuring proper information distribution.
* Serve as a team member for projects with medical writing deliverables, providing feedback on progress.
* Perform data integrity reviews to ensure accuracy.
* Contribute to process improvements and policy development.
* Manage projects according to SOPs and client standards, ensuring timely and on-budget delivery.
* Compile and publish medical writing deliverables as needed.


Qualifications

* Bachelor's degree in life sciences, clinical sciences, English/journalism, or relevant experience in publishing/editing.
* Experience with Adobe Acrobat or similar markup languages; ISIToolbox experience preferred.
* Proficiency in Microsoft Office Suite.
* Strong attention to detail, copyediting, data review, organizational, and communication skills.
* Familiarity with AMA style guide preferred.
* Ability to work independently and in teams, managing multiple deadlines.
* Knowledge of FDA, EU requirements, ICH regulations, and ISO standards preferred.

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 your role, you'll take initiative and challenge the status quo.

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