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Medical Writer (Regulatory)

  • Job type: Contract
  • Location: Edison
  • Salary: Competitive
  • Job reference: MMMWNJ
  • Sector: EPM Scientific, Regulatory
  • Date posted: 13/07/2017
Medical Writer (Regulatory)


Location: Edison NJ Area

Salary: Competitive

Industry: Pharmaceuticals

Job Type: Contract – 12 months




Responsibilities:
  • Preparation of NDA and integrated summaries of efficacy and safety for a wide variety of therapeutic indications.
  • Assistance in the preparation and review of study protocols and study protocol synopses.
  • Assistance in the preparation of study feasibility questionnaires, as well as related reports under the purview of Medical & Scientific Affairs.
  • Production of manuscripts or other print-related media for submission to journals or used in other sponsor-related medical/professional activities as requested and contracted by sponsors.
  • Production of high quality documents in compliance with ICH requirements and WCT standard operating procedures.
  • Good working knowledge of module 2.7.3
 


Qualifications

  • 5 years of medical writing/editing, publication management  
  • Thorough knowledge of Good Publications Practices (GPP2) and Guidelines for Authorship of the International Congress of Medical Journal Editors
  • Significant understanding of regulatory requirements and ICH guidelines
  • Basic knowledge of document management systems
 
Please Apply Below! 


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