Medical Writer
Vor 4 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, editing, and reviewing clinical documentation, including informed consent forms, patient information, and other project-specific clinical documentation.
Key Responsibilities
- Write, edit, and review Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation.
- Write, edit, review, finalize, and track 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.
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.
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