Company Description

PSI is a leading Contract Research Organization with more than 28 years in the industry offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job DescriptionWrites, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentationWrites, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narrativesCollects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical WritingCritically assesses, interprets, and summarizes data from clinical studiesReviews scientific literature pertinent to medical writing activitiesPerforms 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)Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasksCollaborates with the Process Improvement narrative automation team to develop patient safety narratives

QualificationsCollege 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 dataPrior pharmaceutical, biotechnology, or contract research organization experienceBasic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential DocumentsBasic knowledge of electronic Common Technical Document (eCTD) requirements

Additional Information

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.