A major medical device manufacturer is seeking a Sr. Medical Writer. This is a growing company! Ideal candidate will be responsible for the coordination of medical writing processes. Experience with GCP, ICH and FDA requirements pertaining to clinical trials a must.
Requirements:
· Master’s Degree: Biological or health-related field
· Minimum of 5 years experience in the life sciences field
· Experience in writing clinical protocols, study reports, blinded read charters and data monitoring charters
· Must have experience in preparation of NDA and IND documents
· Must have understanding of GCP, ICH and FDA regulatory requirements applying to clinical trials
· Must be a good multi-tasker