PSI
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.
Roles and Responsibilities
- 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.
