Associate Medical Writer
PSI CRO AG
full-time
Posted on:
Location Type: Remote
Location: Canada
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About the role
- 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, preferably a Bachelor's or Master's degree in biomedical or life sciences fields
- Minimum 2 years of experience in medical and/or regulatory writing and related tasks
- 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 documents
- Basic knowledge of electronic Common Technical Document (eCTD) requirement
Benefits
- Health insurance
- Flexible working arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingregulatory writingclinical documentationquality control (QC)patient safety narrativesclinical study report (CSR)document trackingnarrative automationeCTD requirements
Soft Skills
collaborationcommunicationattention to detailorganizational skills