Medical Writer Specialist
Vor 5 Tagen
Job Summary
We are seeking a highly skilled Medical Writer to join our team at PSI. As a Medical Writer, you will be responsible for creating high-quality clinical documentation, including informed consent forms, patient information, and other project-specific clinical documentation.
Key Responsibilities
- Develop and edit Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
- Write, edit, review, and finalize clinical study report (CSR) patient safety narratives
- Collect and track documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
- Critically assess, interpret, and summarize data from clinical studies
- Review scientific literature pertinent to medical writing activities
- Perform 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)
- Act as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
- Collaborate with the Process Improvement narrative automation team to develop patient safety narratives
Requirements
- 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
About PSI
PSI is a leading provider of clinical documentation and data management solutions. We are committed to delivering high-quality services that meet the needs of our clients.
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