Medical Writer II (South Africa)
Parexel International Corporation
South Africa - Any Region - Home Based
Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports.
The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission.
The Medical Writer II may serve as the primary client contact.Qualifications- 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.
- Extensive clinical/scientific writing skills.
- Writing experience of regulatory documents such as clinical study protocols and reports, patient narratives, informed consent forms or similar in a contract research organization, pharmaceutical or biotechnology firm, or experience in the conduct of clinical research/medical communications.
- Scientific background essential.
- 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.
We like to encourage candidates who consider themselves to be more advanced in regulatory medical writing, at any senior or principal level, to submit their application.