Description
<p>ICON has a continuous need for Senior and Principal Medical Writers </p><p><br></p><p><b>Senior Medical Writer</b> – 5+ years of medical writing in a writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.</p><p><b>Principal Medical Writer</b> – 7+ years of medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.</p><p><br></p><ul><li>Must have been the primary writer (Including reviewing and editing) of clinical study documents, including 1) clinical study protocols, 2) clinical study reports (CSRs), 3) investigator brochures (IBs), and 4) regulatory submissions, ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards.</li><li>Bachelor’s degree </li></ul><p><br></p><p><b>What you will be doing</b></p><ul><li>Responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements.</li><li>Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards.</li><li>Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings, and communicate key insights in written form.</li><li>Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.</li><li>Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences, disseminating study results and scientific insights to the broader scientific community.</li></ul><p><br></p><p><b>You Are:</b></p><ul><li>Must be currently working for a CRO, Pharmaceutical or Biotechnology company. </li><li>Must have been the primary writer (Including reviewing and editing) of clinical study documents, including these 1) clinical study protocols, 2) clinical study reports (CSRs), 3) investigator brochures (IBs), and 4) regulatory submissions, ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards.</li><li>Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 5+ years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.</li><li>Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills, and the ability to communicate scientific concepts to diverse audiences.</li><li>Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process.</li></ul><p></p>
