Full-Time Associate Medical Writer

• Writes, edits, and reviews 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.
• Performs quality control (QC) reviews of PSI-developed documents, in support of the Quality Control Associates.
• 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.

Requirements:

• College or university degree in biomedical or life sciences fields, or equivalent experience.
• Minimum 2 years of 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)
• Basic knowledge of electronic Common Technical Document (eCTD) requirement

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