Director Medical Writing
: Job Details :

Our client is an expanding biotech focused within the rare / metabolic disease space looking to bring on an experienced Director Medical Writing to 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 team culture and collaboration high on the companies priorities, also offering an excellent opportunity to learn and develop in a growing organization.

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
• Must have lead writer experience in Clinical Study Protocols, Investigator brochures, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, INDs, NDAs, and 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
• Ability to interact effectively on cross-functional teams and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution)

Education needed:

• PhD / MS in a scientific field