Description
Job Requirements- BA/BS, MS, or PHD in Scientific or Medical Field.
- 5 years of regulatory medical writing experience in the pharmaceutical or biotech industry.
- Experience writing clinical protocols, clinical study reports (ICH E3), and Investigator Brochures for the biotech/pharmaceutical industry. Experience writing CTD Module 2 summary documents, Integrated Summary of Safety, and Integrated Summary of Efficacy preferred.
- Knowledge of ICH E2, E6, and M4E plus CFR 312 and 314
- Experience with an electronic document control and management system
- Ability to manage multiple projects and strong communication skills.
- On Site work only
This Position provides the opportunity to work with an established biotech firm on the forefront of drug development on a contract basis with the opportunity for renewal.
If you would like to be considered for an interview please contact me, and send over an updated resume.