Johnson & Johnson is recruiting for an IT Senior Manager, Technical Product Manager (TPM), Regulatory Excellence to be located in Raritan, NJ; Titusville, NJ or Spring House, PA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Global Regulatory Affairs business technology team is focused on providing leading-edge technology solutions to help drive J&J Innovative Medicine's Global Regulatory Affairs organization, we are currently seeking an IT Senior Manager, Technical Product Manager, Regulatory Excellence.

RESPONSIBILITIES:

The IT Sr Manager, Technical Product Manager for Regulatory Excellence combines modern Information Technology (IT) expertise, and knowledge of the pharmaceutical development business to transform the way IT is applied in Regulatory Affairs with a focus on systems unifying the processes related to Regulatory Operations and the overall user experience of our business customers. The IT Sr Manager TPM has a lead role in the development of a Unified Regulatory Platform (URP) and will lead technical teams, conduct technical analysis activities and technical risk assessments for newly identified technology opportunities. S/he will work with the business to define the URP technical product vision and Objective Key Results (OKR's) to ensure business value is delivered. S/he will engage with internal development teams to design and deliver innovative solutions and ensure effective integrations with systems and technologies in overall systems landscape. S/he is responsible establishing vision, OKRs, roadmaps, development of budget and capital appropriation requests, meeting time and budget requirements, directing technical resources, and helping the business partner(s) realize the desired business goals for URP product(s). To ensure delivery of solutions, s/he will work closely with internal delivery teams, other J&J IT teams, as well as external service providers. The IT Sr. Manager, TPM for Regulatory Excellence will report to the IT Director, Product Group Leader for Regulatory Excellence.

ADDITIONAL SPECIFIC RESPONSIBILITIES INCLUDE:

• Supports the definition of the technical product / platform vision, strategy and OKR's for the Unified Regulatory Platform, aligning business demand with the product/ platform roadmap
• Establish technology roadmaps to achieve efficient & effective delivery of business & customer value for Unified Regulatory Platform product(s)
• Balance business value with technical feasibility while prioritizing features, optimizing cost and improving delivery efficiency
• Further refine the backlog by adding necessary technical features and epics; work with Suppliers and Product owners, with regard to supplier delivered capacity & architectural integration
• Help Product Owners prioritize their backlogs, manage product / platform constraints and resolve cross-team dependencies; manage demand intake as required
• Work in close partnership with the Product Owner and Engineer roles to manage risk in backlog
• Contributes to the documentation and visual representation of the end-to-end view of process, systems and data flows for Unified Regulatory Platform product(s)
• Engages Development systems and JJIM technology platforms, and IT shared services experts to define IT solution strategies that maximize business value and are consistent with business objectives and strategy
• Contributes to, and potentially leads, the business case development for proposed projects
• Estimates cost of development effort and time to deliver prioritized requirements
• Manages project plans, financials, risks and issues for the defined projects and portfolio
• Coordinates business engagement for user acceptance testing, rollout, and adoption
• Ensures compliance with J&J Innovative Medicine policies & regulations, participates in compliance activities as required, and ensures development of required documentation
• Expert knowledge and understanding of standard practices, technology, functions and supporting industry principles in Regulatory Affairs domain (i.e. Veeva, Opentext, ArisG, Calyx, etc...)
• Experience gathering requirements and translating into a product vision through deep expertise in product development, engineering, and UX
• Deep understanding and experience in high quality product delivery, including planning, dependency management, and delivery execution & governance
• Sufficient understanding of the Regulatory business needs, including sufficient knowledge of business processes, relevant value drivers, and industry trends
• Experienced in managing a product backlog/release plan, tracking team level metrics, leading product team ceremonies, removing blockers (burndown chart, release burn up)
• Experience in developing systems and tools to enable customer interactions and collaboration

Qualifications

• A minimum of a Bachelor's degree or equivalent
• At least 6 years of related experience in pharmaceutical development IT is required, preferably focused on Regulatory Affairs IT.
• Practical knowledge of pharmaceutical development business and prior experience in information technology in the regulatory affairs domain, with demonstrated experience driving new systems implementations are required.
• Strong knowledge of regulatory operations, including end-to-end labeling, product and lifecycle registration, dossier management, regulatory information management (RIM), regulatory reporting, IDMP regulations, and data standards. Experience with emerging digital health technology in these settings is preferred.
• Strong communication skills, and strong relationship development and management attributes in a global setting is required.
• Strong knowledge of the system landscape used in regulatory affairs.
• Knowledge of current and new technologies including intelligent automation tools and their applicability to the business is required.
• Aptitude and experience managing the estimation, budgeting, and financial tracking of IT projects is required.
• Practical knowledge of computer systems validation requirements and all necessary compliance requirements for workflow, reporting, and information custody is required.
• Experience in the use of Agile methodology, process engineering and prototyping tools is preferred.
• An authentic leader committed to diversity and the practices that create a passionate, energetic and rewarding work environment, with the ability to inspire a diverse, multi-generational workforce and that recognizes and rewards collaboration, performance and inclusion.
• Up to 15% travel (domestic & international) is required.

The anticipated base pay range for this position is $118,000- $203,550.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (http://www.careers.jnj.com).

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