MEDICAL SURVEILLANCE SPECIALIST II
Location:
Wayne , Pennsylvania
Posted:
January 27, 2017
Reference:
1471161209-en-us

Animas Corporation a member of Johnson & Johnson’s Family of Companies, is currently recruiting for a Medical Surveillance Specialist II, located in Wayne, PA

Animas Corporation, a fully-integrated global company within the Johnson & Johnson family of companies, is an innovator in insulin pump technology, with products such as the ground-breaking OneTouch Ping.  The company is experiencing an unprecedented period of strong growth, outpacing the rapid market growth in the insulin delivery category.  As part of the Johnson & Johnson Diabetes Franchise, the company's mission is to create a world without limits for people with diabetes.  Animas is dedicated to making diabetes management easier through product innovation, exceptional customer support and customized education programs. Our mission is to improve the lifestyle of our patients, reduce the long-term morbidity of the disease and lower healthcare costs.

 

This position works independently to prepare and submit Medical Device Reports (MDRs) to global Health Authorities. Works with minimal supervision to complete and submit reports that are accurate, thorough and completed on-time. Supports some advanced functions within Medical Surveillance as cited below.

 

Job Responsibilities:

  • Using discretion and independent judgment; the Specialist II reviews, evaluates, and classifies potentially reportable complaints (adverse events, product malfunctions or rule-outs) for both U.S. and International reports. Additionally, the Specialist II ensures all documentation is accurate and complete and that all assigned regulatory reports are submitted on-time.

  • The Specialist II works globally to complete MDR submissions and/or to provide support and direction to international representatives/responsible parties.

  • The Specialist II will be proficient in use of the MDR case handling system and associated databases/tools.

  • The Specialist II is a good communicator; able to work in a collaborative environment to resolve issues, answer questions from internal and external customers, and ensure sound decisions when classifying cases.

  • Additional responsibilities include but are not limited to:

  • Production and/or review and/or submission of Alternative Summary Reports or Periodic Summary Reports for Regulatory Authorities.

  • Lead and/or support MDR system change activities (examples include: author test scripts, create test cases, and/or execute testing)

  • Write and/or review SOPs, Work Instructions, or training documents

  • Train colleagues

  • Participate or Lead Process improvement activities

  • Responsible for other duties assigned


Qualifications
  • Four Year College Degree (Bachelors) is required
  • BA/BS in health–related science or life science from an accredited school/university/ college.  Alternatively, may be licensed, registered, or certified by a State, territory, or other governing body to administer health care with at least one to years’ experience in a medical field (RN, RD, CDE, RT, CNA, MA), or patient education would be preferred
  • 3+ years’ experience in medical device or pharmaceutical product quality complaint and/or adverse event case handling is required
  • A working knowledge of FDA and international Health Authority reporting requirements is preferred
  • Must have the ability to make sound business judgments, along with the ability to make independent decisions to ensure compliance with FDA and global Health Authority reporting requirements as these are required
  • Experience writing and filing Medical Device Reports, including knowledge of diabetes and medical terminology is preferred
  • Ability to understand and develop SOP’s, work instructions and training documents is preferred
  • Prior experience with leading a team is preferred
  • Understanding of team training methodology and best practices is preferred
  • This position is located in Wayne, PA and may require up to 10% travel

Primary Location
United States-Pennsylvania-Wayne
Organization
Animas Corporation (6150)
Job Function
Medical Affairs

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