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1 week 5 days ago
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Job Description
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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 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.
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