IT Business Analyst, Regulatory Affairs R&D
Location:
Somerville , New Jersey
Posted:
April 02, 2017
Reference:
2547170216-en-us

Medical Devices, a division of the Johnson & Johnson Family of Companies, is recruiting for an IT Business Analyst, Regulatory Affairs R&D.  This position is located in Somerville, NJ and reports to the Senior Manager, IT Regulatory Affairs Product Line Organization.

 

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

 

Medical Devices represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day.  Work of the MD organization supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.

 

We are looking for a Business Analyst who, with oversight from the IT Regulatory Affairs Product Line Organization, will partner with the R&D Regulatory Affairs Business Process Owners to harmonize processes and provide technology solutions for the Medical Devices Regulatory Affairs Center of Excellence. The IT Business Analyst will be responsible for full software lifecycle management and delivery of solutions at the forefront of technology within the ever-changing landscape. In this role you will create impactful and intuitive products finding solutions to challenging and complex business problems.

 

We are thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  We are proud to be an equal opportunity employer.

 

The IT Business Analyst, Regulatory Affairs R&D will have the following responsibilities:

  • Work with the Regulatory Affairs Business Product Owners to translate business needs for IT solutions and develop/document user stories and/or requirements. This includes data requirements.
  • Develop business cases to secure project funding.
  • Partner with the IT Application Services organization resources to implement the projects following the SDLC Waterfall or Agile methodology for both GxP and Non GxP systems.  (Includes project charters, business case, use cases, user stories, data flows, wireframes…etc).
  • Explain to business partners how requirements may be implemented from a functional standpoint.
  • Coordinate user acceptance testing or assist unit testers so that requirements are satisfied. 
  • Partner with SaaS vendors and/or IT Applications Services “Run” organization to establish ongoing Application Support Resources.
  • Partner with other product lines as needed to determine best implementation path of Regulatory Affairs business needs.
  • Responsible for IT Technical Application Ownership (TAO) for assigned Regulatory Affairs systems throughout their Lifecycle and maintain data in the CMDB (Configuration Management Data Base) as needed.
  • Develop deeper knowledge of specific Regulatory Affairs capabilities to help better define appropriate IT solutions. Maps out business processes to serve as reference for development and IT support.
  • Applies compliance requirements within scope of responsibility, provides documentation and participates in compliance activities as required

Qualifications
  • Bachelor’s degree in the field of computer science, life sciences or business administration
  • Minimum of 6 years’ practical work experience as an IT Business Analyst in a life sciences/healthcare organization
  • Experience developing and maturing processes and systems in a complex regulated environment
  • Previous experience developing business cases to secure project funding
  • Previous experience creating project charters, business cases, use cases, user stories, data flows, and wireframes
  • A strong technical background specifically in software development is required
  • Quickly learns business and complex processes.
  • Ability to understand and work across multiple business domains in support of projects.
  • Strong communication and critical thinking skills.
  • Ability to work alone with minimal supervision and successfully deliver solutions to our business partners.
  • Previous experience coordinating user acceptance testing or assist unit testers so that requirements are satisfied
  • Ability to keep the business interests in mind. Strong business acumen.
  • Strong ability to identify technical solutions to business problems or needs.
  • Experience implementing systems using Agile methodology.
  • Experience with software development methodologies.
  • Proven relationship management skills.
  • Ability to partner with different scrum team members to deliver solutions that meet business needs.
  • 25% domestic and international travel is required

Primary Location
United States-New Jersey-Somerville
Organization
Ethicon Inc. (6045)
Job Function
Business Solutions
Requisition ID
2547170216

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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