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 Description
Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
Collects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
Critically assesses, interprets, and summarizes data from clinical studies
Reviews scientific literature pertinent to medical writing activities
Performs 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 tasks
Collaborates with the Process Improvement narrative automation team to develop patient safety narratives
Qualifications
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
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.
Seniority level
Associate
Employment type
Full-time
Job function
Research
Industries
Pharmaceutical Manufacturing
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