IT Senior Manager, Technical Product Manager (TPM), Regulatory Excellence

$118,000 - $203,550/Yr

Johnson & Johnson - North Wales, PA

Full-time - Mid Level

North Wales, PA

Chemical Manufacturing

About the position

Johnson & Johnson is seeking an IT Senior Manager, Technical Product Manager (TPM) for Regulatory Excellence, located in Raritan, NJ; Titusville, NJ; or Spring House, PA. This role is pivotal in transforming the application of Information Technology (IT) within the Regulatory Affairs sector, focusing on unifying processes related to Regulatory Operations and enhancing the overall user experience for business customers. The IT Senior Manager will lead the development of a Unified Regulatory Platform (URP), overseeing technical teams, conducting technical analyses, and assessing risks associated with new technology opportunities. The position requires collaboration with business stakeholders to define the technical product vision and establish Objective Key Results (OKRs) to ensure that business value is delivered effectively. In this role, the IT Senior Manager will engage with internal development teams to design and implement innovative solutions, ensuring seamless integration with existing systems and technologies. Responsibilities include establishing the vision and roadmap for the URP, managing budgets and capital requests, and directing technical resources to meet business goals. The IT Senior Manager will work closely with various internal and external teams to ensure the successful delivery of solutions, while also reporting to the IT Director, Product Group Leader for Regulatory Excellence. Additional responsibilities include defining the technical product/platform vision and strategy for the Unified Regulatory Platform, aligning business demands with the product roadmap, and balancing business value with technical feasibility. The role also involves refining the product backlog, managing cross-team dependencies, and contributing to the documentation of processes and systems related to the URP. The IT Senior Manager will engage with development systems and technology platforms to define IT solution strategies that maximize business value and ensure compliance with J&J policies and regulations. This position requires a deep understanding of the regulatory affairs domain, including knowledge of relevant technologies and practices, as well as strong communication and relationship management skills in a global context.

Responsibilities

• Lead the development of a Unified Regulatory Platform (URP) and oversee technical teams.
• Conduct technical analysis activities and risk assessments for new technology opportunities.
• Define the URP technical product vision and establish Objective Key Results (OKRs).
• Engage with internal development teams to design and deliver innovative solutions.
• Establish vision, roadmaps, and budgets for URP product(s).
• Direct technical resources to help business partners achieve their goals.
• Support the definition of the technical product/platform vision and strategy for the URP.
• Establish technology roadmaps for efficient delivery of business value.
• Refine the product backlog by adding necessary technical features and epics.
• Help Product Owners prioritize their backlogs and manage product/platform constraints.
• Contribute to the documentation of end-to-end processes, systems, and data flows for URP product(s).
• Engage with development systems and IT shared services to define IT solution strategies.
• Contribute to business case development for proposed projects and estimate development costs.
• Manage project plans, financials, risks, and issues for defined projects.
• Coordinate user acceptance testing, rollout, and adoption of solutions.
• Ensure compliance with J&J policies and participate in compliance activities.

Requirements

• A minimum of a Bachelor's degree or equivalent.
• At least 6 years of related experience in pharmaceutical development IT, preferably focused on Regulatory Affairs IT.
• Practical knowledge of pharmaceutical development business and experience in regulatory affairs IT.
• Strong knowledge of regulatory operations, including labeling, product registration, and regulatory information management.
• Experience with emerging digital health technology is preferred.
• Strong communication skills and relationship management attributes in a global setting.
• Knowledge of the system landscape used in regulatory affairs.
• Understanding of intelligent automation tools and their applicability to the business.
• Experience managing estimation, budgeting, and financial tracking of IT projects.
• Knowledge of computer systems validation requirements and compliance needs for workflow and reporting.
• Experience in Agile methodology, process engineering, and prototyping tools is preferred.

Nice-to-haves

• Experience in developing systems and tools for customer interactions and collaboration.
• Experience in managing a product backlog/release plan and leading product team ceremonies.
• Deep expertise in product development, engineering, and user experience.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health insurance coverage.
• 401(k) retirement savings plan with company matching contributions.
• Paid time off and holidays.
• Opportunities for professional development and continued education.