Safety Systems Program, Senior Analyst
Location:
Fort Washington , Pennsylvania
Posted:
January 12, 2017
Reference:
3640161209/1-en-us

Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc., is recruiting for a Safety Systems Program, Senior Analyst to be located in Fort Washington, PA. Remote work is an option for the right candidate (US Eastern Time Zone only).


Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units:  Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products. 


Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  Proud to be an equal opportunity employer.


The Safety System Program Senior Analyst is an integral role in the Office of Consumer Medical Safety (OCMS), interfacing between the business and IT to assess and troubleshoot system related issues and to plan and implement business-supporting technology solutions.  This role will address system issues experienced by the OCMS operations team, working with the technical teams towards resolution.  In addition, the Safety System Program Senior Analyst will provide project management and business analysis support for OCMS’s operations technology-related projects including: safety data transfers for product divestiture and acquisitions, OCMS SharePoint Site creations / migrations and system interface development and enhancements.          

 
Responsibilities:
  • Assume the business ownership of the Remetrex Safety System (RSS) and will partner with IT for the planning, implementation and validation of all system changes including system and interface enhancements and bug fixes
  • Prepare for and attend the Complaint Vigilance Change Advisory Board meetings.
  • Interface with Complaint Vigilance stakeholders
  • Work with the regional call center system administrators with the master data product scoping.
  • Serve as a safety system subject matter expert on large scale technology projects with the Global Consumer Care Center and Consumer Quality Assurance teams
  • Troubleshoot system and interface issues with IT partners, determining root causes and solutions.
  • Assess and prioritize safety system and interface user requirements with business and IT partners. 
  • Determine with IT partners the appropriate technology solution to meet the prioritized user requirements.
  • Review, approve, reject or defer Safety System change requests.
  • Lead system-specific and interface system Investigations, collaborating with business and IT partners to describe the incident and determine the root cause
  • Determine the need and review of CAPAs related to systems, interfaces, technical issues or processes
  • Assess and prioritize business technical projects with business and IT partners.
  • Determine deliverables, milestones, and timelines for prioritized programs/projects.
  • Assess the need for IT support to resolve OCMS and vendor technical issues.


Qualifications
  • Bachelor’s degree in Life Sciences, IT, or Business with a minimum of 6 years’ experience in Safety Operations System oversight and program management role OR a Master’s degree, MBA, MPH or PharmD and a minimum of 2 years’ experience in Safety Operations System Oversight and program management role is required.
  • Awareness of project management principles is required
  • Awareness of Software Development Life Cycle and Computer System Validation Methodology is required.
  • Demonstrated experience working in a matrix environment leading cross functional teams is preferred.
  • Working knowledge of AE safety databases to identify systems enhancements and efficiencies is preferred.
  • Outstanding written/verbal communication skills and excellent interpersonal skills are required
  • GxP experience and CAPA management experience is preferred


Primary Location
United States-Pennsylvania-Fort Washington
Other Locations
North America-United States
Organization
J & J Consumer Inc. (6101)
Job Function
Drug & Product Safety Operations

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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