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- Principal Medical Writer (South Africa)
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Principal Medical Writer (South Africa)
Parexel International Corporation
Bloemfontein, Orange Free State, South Africa
The Principal Medical Writer:-
* will research, create, and edit all documents associated with clinical research.
* may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents.
* facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input.QualificationsExperience and Qualifications Required:-
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g. ICH-GCP.
- Excellent clinical/scientific writing skills (minimum 5 years experience required)
- Broad experience in preparation of all types of clinical regulatory documentation.
- Experience in management of complex medical writing projects.
- Scientific background essential.
- Knowledge of resource management and productivity metric management.
- Advanced word processing skills, including MS Office (proficiency in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
- Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
- Ability to travel.
Job posted: 2020-11-13