PSI CRO AG is hiring a
Associate Medical Writer
PSI CRO AG
π΅ ~$140k-$170k
πRemote - United States
Please let PSI CRO AG know you found this job on JobsCollider. Thanks! π
Summary
Join a leading Contract Research Organization as a Medical Writer, responsible for writing, editing, and reviewing Essential Documents, clinical study reports, and other project-specific documentation.
Requirements
- College or university degree, preferably a Bachelorβs/Masterβs degree in biomedical or life sciences fields
- 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
Responsibilities
- Writes, edits, and reviews Essential Documents
- Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
- Collects and tracks documents for CSR appendices
- 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
- 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
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Please let PSI CRO AG know you found this job on JobsCollider. Thanks! π