System One Services Clinical Narrative Writer in Summit, New Jersey

Clinical Narrative WriterSummit, NJ

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Type:Contract

Category:Scientific & Clinical

Job ID:128826

Date Posted:05/17/2018

Joule, a System One division is seeking a Clinical Narrative Writer for a contract position. With more than 6,000 employees and roughly 40 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

The Clinical Narrative Writer will:

Responsibilities:

  • 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.

  • 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 CR&D.

Requirements:

  • 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.

  • 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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