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Oncology Clinical Narrative Writer

New Jersey All, NJ

Posted: 09/10/2019 Job Type: Clinical Job Number: JN -092019-25579

Authoring of Clinical Study Subject Narratives for assigned studies

Review work of other writers for accuracy, quality, focus, and adherence to format and stylistic requirements

Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation

Requirements:

BS degree (Masters preferred)

10+ years in the pharmaceutical industry or in a CRO

3-5+ years of oncology clinical narrative writing experience

Extensive experience writing all types of clinical and regulatory documents

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; proven ability to problem solve and identify inconsistencies or inaccuracies in data listings

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