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.
Associate Medical Writer
Collects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing. Performs quality control (QC) reviews of PSI-developed Essential Documents and other documentation (in support of the Quality Control Associates ...
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