Associate Medical Writer

Summary

Join PSI, a leading Contract Research Organization, and contribute to the creation and review of essential clinical documents. You will write, edit, and finalize documents such as informed consent forms, patient information, and clinical study reports. Data interpretation and summarization are key aspects of this role, along with collaboration with various teams. The position requires a minimum of two years of relevant industry experience and a strong understanding of global regulations and guidelines. PSI offers a supportive environment focused on employee growth and development.

Requirements

• College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life sciences fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities
• Minimum 2 years of corresponding industry experience working with clinical documentation and data
• Prior pharmaceutical, biotechnology, or contract research organization experience
• Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
• Basic knowledge of electronic Common Technical Document (eCTD) requirements

Responsibilities

• Write, edit, and review Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
• Write, edit, review, finalize, and track clinical study report (CSR) patient safety narratives
• Collect and track documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
• Critically assess, interpret, and summarize data from clinical studies
• Review scientific literature pertinent to medical writing activities
• Perform quality control (QC) reviews of PSI-developed Essential Documents and other documentation (in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing)
• Act as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
• Collaborate with the Process Improvement narrative automation team to develop patient safety narratives