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.

You will be supporting a Top-5 pharma company, helping our customer deliver best-in-class regulatory and submission documents. While being stably employed with ICON, you will be fully embedded with our client.

Responsibilities

• Independently produce 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, covering 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.
• Act as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.
• Facilitate the review of the documents and ensure that documents are submission-ready and approved. When preparing documents, you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.

Qualifications

• Minimum requirement of a bachelor’s degree; Master's degree preferred.
• 3-5 years of Medical Writing experience & other relevant pharmaceutical experience combined with scientific and regulatory knowledge.
• Strong writing skills and the ability to convert scientific data into 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 approved.