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Senior Clinical Narrative Writer

New Jersey All, NJ

Posted: 09/26/2018 Job Type: Clinical Job Number: JN -092018-22660
  • 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
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
  • Proven ability to problem solve
    Identify inconsistencies or inaccuracies in data listings
Qualifications:
  • BS degree in biomedical science (Masters preferred)
  • 10+ years in the pharmaceutical industry or in a CRO
  • At least 3+ years of Oncology clinical narrative writing experience

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