Clinical Narrative Writer
New Jersey All, NJ
Support the overall Clinical Study Subject Narratives Process within Hematology/Oncology by authoring and coordinating the Clinical Study Subject Narratives for assigned studies.
Responsibilities will include:
Authoring of Clinical Study Subject Narratives for assigned studies, this will include the review of clinical data listings, as well as data from the safety database, to construct a clinical story of subjects enrolled in a study, in the form of a clinical narrative. Review work of other writers for accuracy, quality, focus, adherence to format and stylistic requirements, and the clarity, logic and order of presentation.
Extensive recent experience writing all types of clinical and regulatory documents for worldwide use; recent CR&D experience as a clinical medical writer, clinical research scientist, clinical data manager or similar, 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, proficiency in data interpretation, sound organizational skills. Experience interfacing with multiple teams, including clinical research scientists, clinical research physicians and statistical programmers, and proven ability to problem solve and identify inconsistencies or inaccuracies in data listings.
BS Degree (Masters preferred) with 10+ years in the pharmaceutical industry or in a CRO, including required 3+ years Oncology clinical narrative writing (not drug safety writing)