Janssen R&D, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior IT Manager, Regulatory & Safety Innovation, BA (Business Analyst)/SA (Solution Architect). 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 & Safety PLO and will focus on working with the safety and regulatory business and IT organizations specifically focusing on innovation strategies. The Senior IT Manager, Regulatory & Safety Innovation, BA/SA will support and partner with the Business Technology Leaders and Product Line Owners for Regulatory and Safety in delivering innovative solutions to drive the business strategy. She or he will have a broad knowledge of regulations and understand the industry landscape.
The Senior IT Manager, Regulatory & Safety Innovation, BA/SA will:
• Collaborate with BTLs (Business Technology Leaders), PLOs (Product Line Owners) and business partners to define technology strategy that maximizes business value.
• Demonstrate an in-depth understanding of regulations that will impact our business partners (e.g. IDMP, E2B R3).
• Participate in industry forums and collaborations.
• Understand the business processes and challenges that impact out business partners.
• Work collaboratively with IT and business partners to strategize on innovative solutions.
• Contribute to the business case development for proposed projects.
• Work with business to translate regulatory requirements for IT delivery.
Additional key responsibilities:
• Serve as an expert resource supporting one or more areas, processes, or technologies in Regulatory and Safety.
• Understand current regulations and keep up to date with regulatory changes.
• Build and maintain strong partnerships with business, business technology leaders and product line organizations.
• Contribute to the documentation and visual representation of the end-to-end view of process, systems and data flows.
• Contribute to business strategy and technology roadmaps.
• Maintain a strong industry network to leverage for collaborations.
• Bachelor’s degree and a minimum of 8 years of relevant experience OR advanced degree with a minimum of 6 years of relevant experience is required.
• Strong knowledge of regulatory processes and technologies is required.
• Successful 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.