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2017-43191

2017-43191

Title 
Sr. Medical Writer - Home based- Oncology
Job Locations 
-
US-Remote
Posted Date 
10/13/2017

More information about this job

Overview

   Demonstrates ability to use computerized systems (PC-Windows and MS Word). Exhibits excellent written and oral communication and presentation skill. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documentation.Researches, writes, and edits clinical documents by applying functional expertise and clinical drug development knowledge.

Responsibilities

 

  • Contributes to project plan concerning organization and table layout for a specific document.
  • Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.
  • Review study concepts and edit protocols for consistency, progression, structure, and grammar.
  • Review statistical analysis plans and incorporate into clinical study reports.
  • Drive the document preparation process, receive and review primary statistical output, draft and distribute document for review, and compile comments and edits as necessary.
  •  Participate in team and client meetings as requested

 Demonstrates ability to use computerized systems (PC-Windows and MS Word).
•    Exhibits excellent written and oral communication and presentation skills.

Qualifications

  • Advanced degree in a relevant scientific/clinical/regulatory field preferred
  • At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
  • Global regulatory submission experience.
  • Excellent writing skills.
  • Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
  • Knowledge of current requirements and guidelines applicable to submission documents
  • Excellent interpersonal and oral communication skills.
  • Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Ability to prioritize multiple projects




PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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