Clinical Narrative Writer - NJ in Summit, NJ at Apex Life Sciences

Date Posted: 4/14/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
    Legal
  • Experience:
    Not Specified
  • Date Posted:
    4/14/2018
  • Job ID:
    830851

Job Description


Description:

  • 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. 

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. 

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

Qualifications: 

  • 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.

To apply to this position please send your resume or contact:

Vickie Dagit, Recruiter

vdagit@apexlifesciences.com

919-334-0178