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.