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MDR - Medical Writer III
Ref No.: 18-13829
Location: North Haven, Connecticut
Position Type:Contract
Start Date / End Date: 03/08/2018 to 03/04/2020
Company: Artech Information Systems
Job Title: Medical Writer
Job ID: 18-13829
Location: North Haven, CT
Duration: 24 months

 
Must haves
Reg Writing Experience 
Advanced Degree 
Renal Care experience 
 
Summary of Position: 
The Medical Writer is responsible for the preparation of documents that support the presentation, publication needs of assigned therapeutic areas and/or products in the Healthcare Scientific Communications group. 
 
Essential Functions: 
  • This role predominantly focuses on writing, editing and reviewing regulatory (e.g. Clinical Evaluation Reports/clinical study reports/summaries) documents and responses to Notified Bodies. 
  • Post Market Surveillance activities (monthly literature review of our product) 
  • Scientific Writing e.g. abstracts, manuscripts, presentations 
  • Requires a strategic understanding of the therapeutic areas, business and study objectives as well as statistical data 
  • Independently, critically writes and edits scientifically complex documents for substantial intellectual content 
  • Reviews and provides input on the data being considered for publication to ensure alignment with current medical issues and corporate goals 
  • Expert knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practices 
  • Ability to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiences 
 
Education & Experience: 
  • Ph.D./Pharm.D plus 1 to 2 years of related pharmaceutical/medical device industry experience (e.g., medical writing, clinical research) 
  • BS, B.Pharm, MS, plus 4 to 6 years of relevant pharmaceutical/medical device industry experience 
  • Clinical, scientific or research background 
 
Preferred Skills/ Qualifications:
  • Experience in Medical Writing 
  • Communication/Presentation Skills 
  • Excellent Interpersonal Relationships 
  • Expert understanding of scientific or clinical research and the scientific method 
  • Demonstrated scientific writing ability 
  • Must be highly proficient in the use of Microsoft Office suite (especially Microsoft Word and PowerPoint); skill in Microsoft Excel, Photoshop, Illustrator, EndNote Reference Software, and other scientific graphics software would be helpful 
  • Good understanding of statistical methods
 
Thanks & Regards
Rajiv Maruthi
Rajiv.maruthi@artechinfo.com