Previous Job
Previous
Clinical Narrative Writer
Ref No.: 18-14195
Location: Summit, New Jersey
Position Type:Contract
Start Date / End Date: 10/15/2018 to 04/13/2019
Sunrise System Inc. is currently looking for Clinical Narrative Writer in Summit, NJ with one of our top client.
Job Title: Clinical Narrative Writer
Job Id: 18-14195
Location: Summit, NJ 07901
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
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. 
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 0326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com