Senior Medical Writer

Overview

As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

 

As a Senior Medical Writer you will be supporting a Top-5 pharma company. You have the chance to help our customer to deliver best-in-class regulatory and submission documents. While being stably employed with ICON, you will be fully embedded with our client. 

Responsibilities

• Independently produces clinical and regulatory documents in collaboration with Principal Medical Writers . These documents may include clinical study level documents such as clinical summary documents, protocols, CSRs, IBs, briefing books and response documents, PIPs .This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas.
• Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.
• Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.
• Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.

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Qualifications

• Minimum requirement of a bachelor’s degree; Master's degree preferred
• 3-5 years Medical Writing experience & other relevant pharmaceutical experience combined with scientific and regulatory knowledge
• Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured messages.
• Proficient in independently writing several types of clinical/regulatory documents (protocols, CSRs, etc.) including leading creation, coordination of the authoring functions, facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved.