Description
This position will be responsible for writing/revising regulatory documents in support of drug development, including clinical protocols, clinical study reports, patient narratives, investigator brochures and more.Requirements:
- Bachelors Degree or higher
- Locally based candidates need as the individual will need to attend key meetings
- Minimum of 5 years of regulatory medical writing experience
- Experience writing clinical protocols, clinical study reports (ICH E3) and Investigator Brochures for the biotech/pharmaceutical industry
- Working knowledge of ICH E2, E6, and M4E plus CFR 312 and 314
- General knowledge of applied clinical medicine and laboratory interpretation
- Experience with small-molecule drug development is preferred
This is a great opportunity with a leading biotech company. If interested please apply immediately.
To find out more about Real please visit www.realstaffing.com