Building a career in the Pharmaceutical field. I have experience in medical communications, clinical, regulatory document & medical writing. The bulk of my experience in clinical trials/research involved preparing and working with:
-Clinical Study Protocols, Protocol summaries, Protocol amendments
-Clinical Study Reports
-Informed Consent Forms
-Clinical Trial Data and Case Report Forms
-Investigators’ Brochures & Device User Manuals
-Scientific publications: Manuscripts, Abstracts & Conference/Marketing Presentations
-Managing IRB communication, Trial Master File reconciliation, Manuscript editing and submission.More...