Skills/Knowledge Required: Extensive experience writing all types of clinical and regulatory documents for worldwide use, expertise in the Oncology therapeutic areas, experience in worldwide registration studies and large studies, understanding and good use of all study documents. Protocol, SAP, CRF, SMQs, expertise in MS WORD, including the ability to solve technical problems with WORD templates, excellent grammatical and communication skills. Both written and oral, knowledge of FDA and ICH guidelines, ability to work with multiple complex projects at a time, ability to anticipate and resolve problems working independently, Experience working with automated data solutions in clinical documents, experience working with CROs, proficiency in data interpretation, sound organizational skills. Experience interfacing with multiple teams, and proven ability to problem solve and identify inconsistencies or inaccuracies in data listings.
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