Associate Medical Writer
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Job Location:
Any - USA
Monthly Salary:
Not Disclosed
Posted on:
1 hour ago
Vacancies:
1 Vacancy
Job Summary
- 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.
Qualifications :
- College or university degree preferably a Bachelors or Masters degree in biomedical or life sciences fields or an equivalent combination of education training and experience that presents the required knowledge skills and abilities. Equivalency is defined as a minimum of 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
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.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
