Medical Writer Specialist
vor 2 Monaten
Job Summary
At PSI, we are seeking a highly skilled Medical Writer Specialist to join our team. As a Medical Writer Specialist, you will be responsible for creating, editing, and reviewing essential documents, including informed consent forms, patient information, and other project-specific clinical documentation.
Key Responsibilities
- Develop and finalize clinical study reports (CSRs) and patient safety narratives, ensuring accuracy and compliance with regulatory requirements.
- Collect and track documents for CSR appendices, supporting the Quality Control Associates and Associate Director, Medical Writing.
- Critically assess, interpret, and summarize data from clinical studies, identifying key findings and trends.
- Review scientific literature relevant to medical writing activities, staying up-to-date on industry developments and best practices.
- Perform quality control (QC) reviews of PSI-developed essential documents and other documentation, ensuring consistency and accuracy.
- Collaborate with the Process Improvement narrative automation team to develop patient safety narratives, leveraging expertise and knowledge to drive innovation.
Requirements
- College or university degree in a biomedical or life sciences field, or a relevant combination of education, training, and experience.
- Minimum 2 years of industry experience working with clinical documentation and data, with a strong understanding of global regulations and guidelines (FDA, ICH).
- Prior experience in pharmaceutical, biotechnology, or contract research organization settings, with a focus on regulatory affairs and medical writing.
- Basic knowledge of electronic Common Technical Document (eCTD) requirements and global regulatory frameworks.
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