Clinical Narrative Writer
Newark Metro Area, NJ
- Clinical Narrative Writer
Person will support the overall Clinical Study Subject Narratives Process within Hematology/Oncology by authoring and coordinating the Clinical Study Subject Narratives for assigned studies. This role will be a part of the Clinical Narrative Writing Group within R&D.
Responsibilities will include:
Authoring of Clinical Study Subject Narratives for assigned studies, Review work of other writers (in-house or consultant) 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.
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.
BS degree in biomedical science (Masters preferred) with 10+ years in the pharmaceutical industry or in a CRO, including 3+ years Oncology clinical narrative writing.