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IT Manager, Medical Devices R&D Regulatory Affairs


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

This role will report to the Sr. IT Manager, Medical Device R&D Regulatory Systems Product Line Organization. Partnering with the R&D Regulatory Affairs business process owners and IT colleagues, this role will contribute to building an overall strategy and roadmap to advance business capabilities and will have direct responsibility for delivery of projects within the Regulatory Affairs portfolio.

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.

With $71.9 billion in 2016 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

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

Role Overview :

The IT Manager, MD Regulatory Affairs R&D will work as part of the MD IT R&D Clinical Research, Medical Affairs and Regulatory Affairs Product Line Organization and will:

  • Manage business partner expectations, elicit business requirements, and resolve conflicts related to requirements, timelines and budgets
  • Determine which standardized approaches would ensure complete understanding by downstream stakeholders as well as business and stakeholders of the requirements including use cases and/or user stories, visualization, mapping and other SDLC requirement artifacts including use of the baseline framework to map to business process flows.
  • Document confirmed business processes to serve as reference for development and IT support
  • Explain to business how requirements may be implemented from a functional standpoint
  • Apply compliance requirements within scope of responsibility, provide documentation and participate in compliance activities as required
  • Prepare and update traceability matrix
  • Negotiate with business on priority capabilities for inclusion in delivery sprints and product releases.
  • Facilitate user acceptance testing (UAT)
  • Embed agile practices into projects and guide stakeholders on agile methodology and practices
  • Ensure solutions are consistent with business objectives and strategy and J&J technology standards
  • Align with stakeholders and development teams on product goals and engage business throughout the development process.
  • Develop project budgets and track spend
  • Manage delivery of assigned projects
  • Track and report status of projects
  • Build and maintain strong partnerships with business and BTL & other PLO organizations
  • Partner closely with J&J IT Applications Services and external solution providers to deliver impactful and intuitive solutions to address complex business problems.
  • Develop/maintain strong view of external capabilities and their ability to drive business value
  • Contribute to technology strategy and roadmaps for product lines
  • Contribute to optimizing application portfolio and operating costs to drive ongoing business value
  • Recommend creative/innovative approaches to increase the effectiveness of the technology product line
  • Technical Application Owner for diverse group of solutions planning for delivery of life cycle upgrades and oversight of application support

Qualifications
  • A minimum of a Bachelor’s degree is required; A Bachelor’s or higher in the field of computer science, engineering, science or business administration is preferred.
  • A minimum of five (5) years of related IT experience in Life Sciences/Healthcare is required
  • Knowledge of industry and business process trends related to R&D Regulatory Affairs and Capabilities is preferred.
  • Preferred experience developing and maturing processes and systems in a complex research, manufacturing or product discovery environment
  • Required experience eliciting business requirements using a standardized methodology
  • Contractor management experience: Prior experience managing a technical support team preferred
  • A strong technical background is required
  • Project Management experience is required
  • Knowledge of enterprise architecture preferred
  • Application development methodologies is required
  • The ability to quickly learn the business and complex processes involved is required
  • The ability to understand and work across multiple business domains in support of projects and strong communication and critical thinking skills are required
  • The demonstrated ability to partner with development teams that support various technology platforms is required.
  • Proven relationship management skills are required
  • Technology leadership experience is preferred
  • Up to 10% travel (domestic and international) may be required

Primary Location
United States-New Jersey-Somerville
Other Locations
North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-Massachusetts-Raynham
Organization
Ethicon Inc. (6045)
Job Function
Business Solutions
Requisition ID
3917170619