Janssen Research and Development, LLC, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a IT Manager, Regulatory Execution & Delivery PLO. This role may be located at any of the major Pharm R&D US locations in NJ and PA including Titusville, NJ; Raritan, NJ; Horsham, PA; and Malvern, PA and may require up to 20% local travel between sites.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
This role will be part of the Regulatory Execution & Delivery PLO and will focus on working with the Global Regulatory to deliver a future state technology reporting platform.
The IT Manager, Regulatory Execution & Delivery PLO (Product Line Owner) will support the Product Line Owner for Regulatory in delivering solutions to drive the business and product line strategies. S/he will partner with the business process owner(s) to define needs; work closely with the development team to translate needs; and ensure successful delivery of technological capabilities.
The IT Manager, Regulatory Execution & Delivery PLO will:
•Lead Phases of the RIM program, Submissions Publishing Technologies workstream. RIM is a program to implement the next generation technology platform to support Global Regulatory and JRO. The organization is transitioning from legacy solutions to next generation solutions in this domain.
•Manage software vendor relationships and manage vendor resources on assigned programs.
•Participate in proactive communication strategies and ensure all engaged stakeholders have the appropriate levels of information available to them.
•Manage program resource availability and forecasts future needs.
•Collaborate with the BTL and business partners to define technology strategy that maximizes business value.
•Define priorities and associated technology investments to deliver maximum value.
•Contribute to the business case development for proposed projects.
•Work with business to translate requirements for IT delivery. Deliver SDLC artifacts (project charters, uses cases, etc) in a consumable format for business and developers.
•Apply quality and compliance requirements, provide documentation as necessary, and participate in compliance activities as required.
•Serve as an expert resource supporting one or more areas, processes, or technologies in Regulatory.
•Manage business partner expectations, resolving conflicts.
•Negotiate the needs of multiple users or business partners.
•Stay current on latest technology solutions as well as new /changing regulations
•Ensure solutions are consistent with business objectives and strategy.
•Build and maintain strong partnerships with business and product line organization.
•Contribute to the documentation and visual representation of the end-to-end view of process, systems and data flows.
•Contribute to budget development and monitor budget within area.
•Bachelor’s degree and a minimum of 6 years of relevant experience OR advanced degree and a minimum of 4 years of relevant experience is required.
•Strong knowledge of Regulatory processes and technologies is required.
•Successful Regulatory project delivery experience is required.
•Broad technology experience with ability to lead assessments of proposed solutions and develop recommendations is required.
•Understanding of the business impact of different solutions and ability to assess impact and communicate the tradeoffs between business needs, technology requirements, timelines, costs and risks is required.
•Understanding of departmental budgets and the ability to allocate resources accordingly is required.
•Thorough understanding of SDLC including requirements elicitation, system design, development and validation/regulatory requirements is required.
•Strong communication and interdependent partnering skills in global setting is required.
•Project Management Certification Required
•PMx Certification preferred
•Knowledge of Parexel’s Insight Suite for Regulatory Submissions, as well as report Publishing based on CSC’s ISI Publisher preferred
•2 years experience in Content Management technologies and principles including Microsoft Office, Adobe Acrobat, eCTD Publishing, and Report Level Publishing.
United States-New Jersey-RaritanOther Locations
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-HorshamOrganization
Janssen Research & Development, LLC. (6084)Job Function