Clinical Documentation Specialist

hace 4 días


Madrid, Madrid, España Icon A tiempo completo

Overview

We are seeking a Clinical Documentation Specialist to join our team at Icon, the world's largest and most comprehensive clinical research organization. As a key member of our medical writing team, you will be working closely with a Top-5 biotech company to develop best-in-class regulatory and submission documents.

About the Role

This is an exciting opportunity for a highly skilled Clinical Documentation Specialist to work on a challenging project focused on autoimmune diseases. You will be responsible for delivering high-quality clinical, regulatory, and submission documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, eCTD modules, and other clinical and regulatory documents.

Your Key Responsibilities

  • Draft and manage documents that are superbly organized, accurate, consistent, unambiguous, and written for the target audience.
  • Take a lead role in advising and guiding clinical teams on content and processes.
  • Ensure that all applicable company SOPs and regulations are upheld.
  • Lead in a multi-shareholder environment to ensure seamless delivery of best-in-industry regulatory documents.
  • Closely interact with clinical program leadership and clinical teams to set up and safeguard challenging project deadlines.

Your Qualifications

  • A minimum of 6 years of experience in pharmaceutical/biotechnology-related medical writing.
  • A Master's degree in a scientific, medical, or clinical discipline or related field is required; a PhD is preferred.
  • The ability to interpret and implement all FDA and ICH guidelines for clinical reporting.
  • eCTD development and submission experience is preferred.
  • A pivotal understanding of key phases, processes, and techniques of drug development from protocol development through submission.

What We Offer

  • An estimated salary range of $120,000 - $180,000 per year.
  • A competitive benefits package.
  • The opportunity to work on a challenging project focused on autoimmune diseases.
  • A chance to be part of a dynamic and growing team at Icon.

About Us

Icon is the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence. We are committed to helping our clients deliver best-in-class regulatory and submission documents.



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