Associate Medical Writer at PSI CRO

United States

<h3>Company Description</h3><p>We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.</p><h3>Job Description</h3><ul><li>Writes, edits, and reviews documents, including informed consent forms, patient information, and other project-specific clinical documentation.</li><li>Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives.</li><li>Collects and tracks documents for CSR appendices, in support of the Quality Control Associates.</li><li>Performs quality control (QC) reviews of PSI-developed documents, in support of the Quality Control Associates.</li><li>Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks.</li><li>Collaborates with the Process Improvement narrative automation team to develop patient safety narratives.</li></ul><h3>Qualifications</h3><ul><li>College or university degree, preferably a Bachelor's or Master's degree in biomedical or life sciences fields, or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities. Equivalency is defined as a minimum of 2 years of experience in medical and/or regulatory writing and related tasks.</li><li>Minimum 2 years of corresponding industry experience working with clinical documentation and data</li><li>Prior pharmaceutical, biotechnology, or contract research organization experience</li><li>Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of documents</li><li>Basic knowledge of electronic Common Technical Document (eCTD) requirement</li></ul><h3>Additional Information</h3><p>If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.</p>