Senior Medical Writer

The ESTERN Medical Regulatory Services Center of Excellence is responsible for ensuring that work undertaken by ESTERN Medical Early and Late Stage Development Services meets the requirements of government regulatory agencies locally and worldwide. This responsibility includes the preparation of a variety of clinical documents including protocols and clinical study reports for Phase I to IV clinical trials run by ESTERN Medical globally, in collaboration with other ESTERN Medical units as necessary.It is the responsibility of the Senior Medical Writer to prepare such documentation to the required standard in a timely fashion. The Senior Medical Writer is also responsible for providing this service and associated advice to clients. The Senior Medical Writer is expected to acquire a competency in the use of Documentum and associated tools.Education/Qualifications

BA or BS in life sciences with minimum 8 years relevant experience, MS in life sciences with minimum 5 years relevant experience, or PhD in life sciences with 2 years minimum relevant experienceExperience

Experience in the preparation of clinical documentationExperience in data handling and data analysisGood written and verbal communication skillsAbility to write fluent and grammatically correct EnglishGood organizational and time management skillsPays attention to detailAbility to work to tight timelines while maintaining accuracyAbility to work to a variety of client-driven specificationsGood team playerFamiliarity with Quality Assurance and Quality Control proceduresISS/ISE experience, especially in electronic CTD format.Experience and track record with IND’s, NDA’s, PMA’s, 510K’s, IDE’sA plus if fluent in English & Spanish written and verbally.

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