Medical Editor for Regulatory Documents

hace 3 semanas


Málaga, Málaga, España Pharmiweb A tiempo completo
Job Summary:

We are seeking a highly skilled Medical Editor for Regulatory Documents to join our team. As a Medical Editor, you will be responsible for ensuring that documents meet or exceed sponsor and regulatory requirements and guidance.

The ideal candidate will have a strong understanding of FDA, EU, and other relevant guidelines and industry standards, as well as excellent copyediting, data integrity review, and analysis skills.

This role will also involve representing the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.

Key Responsibilities:

  • Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards.
  • 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.
  • Provides technical support and expertise as needed.
  • 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.

Requirements:

  • Bachelor's degree in the life sciences, clinical sciences, or English/journalism.
  • Significant relevant publishing experience.
  • Strong proficiency in Microsoft Office Suite.
  • Excellent attention to detail and analytical skills.
  • Ability to work with minimal supervision on multiple assignments with set deadlines.

About Syneos Health:

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 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.

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.


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