Manager, Medical Writing

Title: Manager, Medical Writing
Department: Medical Writing
Location: Primarily Home Based
Employment Type: Full Time

Job:

The Manager of Medical Writing should write, edit and manage high quality clinical documentation for submission to regulatory authorities. Medical Writing is a vital part of clinical research, and you will work closely with colleagues in the regulatory affairs, biostatistics, project management, and pharmacovigilance teams to deliver accurate timely documents which meat the highest ethical and scientific standards.Your primary responsibilities will include contributing to and managing the writing of:

Clinical Study Reports (CSRs); (Phases I to IV)

Study Protocols

-Clinical and non clinical sections of the Common Technical Document (CTD)
-Investigator Brochures
-Patient safety narratives
-INDs and NDAs
-Patient information including Informed Consent and Patient Brochures

Minimum requirements:

-Advanced degree in the life sciences (MS or Ph)
-5-8 years previous relevant experience.
-Excellent data interpretation and presentation skills
-Good knowledge of clinical documentation and clinical development process
-Experience coordinating writing activities for regulatory submissions
-Ability to manage other medical writersTo find out more about Real Staffing please visit www.realstaffing.com