Our client is an expanding biotech focused within the rare / metabolic disease space looking to bring on an experienced coordinator and lead writer for documents such as clinical study protocols, clinical study reports, investigator’s brochures, summary sections of regulatory submissions.
Reporting directly into the Senior Director Medical Writing, with a open scope for progression in multiple directions.
The ideal candidate will work with minimal guidance to achieve goals; and is recognized as a scientific contributor and subject matter expert.
Experience needed:
- At least 6 years actively writing regulatory documents
- Lead writer (4 years’ experience) on Clinical Study Protocols, Investigator brochures, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, NDAs, BLAs.
- Experience working with clients and authors on documents including coordinating review cycles, meeting and project timelines
- Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures
Education needed:
- PhD / PharmD / MS in a scientific field
