Principal Medical Writer (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.