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Manager, Medical Information

Cambridge, MA 02142

Posted: 03/20/2018 Job Category: Clinical: Medical Writing Job Number: 1836

Our client is seeking a Manager, Medical Information who will report to the Associate Director, Medical Information.

Job  Responsibilities:
  • Supports day to day operations of Medical Information Services function
  • Responsible for the Creation and maintenance of MI documents and ensures that information is scientifically accurate, timely, balanced, and meet customers’ needs
  • Manages medical information responses and materials through the internal medical, legal and regulatory review process  
  • Responsible for tracking responses to medical information requests from internal and external customers through the MI Response Center vendor 
  • Responsible for ensuring that the documentation of the MI inquiries and responses accurately and completely comply with relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
  • Monitors adverse events and product quality complaints and processes in accordance with company SOPs
  • Assists in the creation of metric reports on key business processes to monitor Medical Information services
  • Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
  • Perform critical analysis and synthesis of internal/external literature related to products and therapeutic areas of focus
  • Exhibits broad knowledge of assigned therapeutic areas, product labelling and regulatory guidance
  • Serves as Medical Affairs liaison to cross-functional groups for the incorporation of current medical/scientific information into departmental documents and processes. 

Qualifications/ Requirements:
  • Advanced clinical and scientific training/experience required equivalent to PharmD, PhD, MD or other advanced degree
  • Minimum of 2 years Medical Information experience with 5+ years in the pharmaceutical/ biotechnology industry
  • Understanding of and adherence to regulatory policies governing scientific interactions with physicians
  • Experience working with vendors on a day-to-day basis
  • Experience with data management and informatics;
  • Excellent written and oral communication skills;
  • Prior industry experience in a post-marketing setting
  • U.S. Launch experience; Orphan, CNS, and / or acute care preferred
  • Ability to quickly understand and communicate all clinical data / publications to support business objectives
  • An outstanding track record of strong communication, presentation, analytic and strategic capabilities
  • This position requires US and international travel, approximately 10 – 25%

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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