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Senior Manager- Technical Product Manager Regulatory Strategy - 2406192765W

Description

The R&D 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, The R&D Regulatory Affairs business technology team is the strategic information technology partner enabling the GRA organization to be a strategic partner and core capability in R&D focused on maximizing and maintaining the value of our therapies throughout their lifecycle. A trusted collaborator with worldwide health authorities. A learning and future focused organization that adapts to a dynamic environment.

Responsibilities:

The IT Senior Manager, Technical Product Manager for Regulatory Insights and Experience combines consulting, 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 regulatory insights and improving the user experience of our business customers. The IT Senior Manager TPM has a lead role in the execution of IT product management and, to do this, will lead business analysis activities and business risk assessments for newly identified technology opportunities. The IT Senior Manager, TPM will partner closely with regulatory affairs leaders to document business processes, optimize these processes, and establish efficient and innovative new approaches for the business. S/he will work with the business to refine the product vision and Objective Key Results to ensure business value is being delivered. S/he will engage with internal development teams to design and deliver innovative solutions leveraging intelligent automation capabilities and will ensure effective integration with systems and technologies in existing system landscapes. S/he is responsible for ensuring the outcome of one or more technology products, including establishing vision, OKRs, roadmaps, development of budget and capital appropriation requests, meeting time and budget requirements, directing all project resources, and helping the business partner(s) realize the desired business goals for the product(s). To ensure delivery of solutions, s/he will work closely with internal delivery teams, other J&J R&D IT TPMs and TPOs, as well as J&J IT and external service providers. The IT Senior Manager, TPM for Regulatory Insights and Experience reports to the IT Director, Product Group Leader for Regulatory Strategy.

Additional Responsibilities Include:

• Through ongoing consultation with the business, identifies and analyzes business needs, ensures scope and requirements are aligned and creates opportunities for innovation in process changes and innovative technology enabled solutions to further develop the Regulatory Insights and Experience product.

• Contributes to the documentation and visual representation of the end-to-end view of process, systems and data flows.

• 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.

• Structures and evaluates POCs. Contributes to business case development for successful PoCs and develops plans to scale and integrate in the broader system landscape.

• 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.

• Tracks benefit realization from the delivered capabilities.

• Manages business partner expectations and resolves conflicts.

• Negotiates the needs of multiple stakeholders.

• Presents product health at Quarterly Business Reviews.

Professional experience:

• Deep knowledge of the pharmaceutical development business and prior experience in information technology supporting pharmaceutical development preferably in the global regulatory affairs domain.

• Deep knowledge of regulatory operations, including end-to-end labeling, product and lifecycle registration, regulatory intelligence, regulatory strategy, dossier management, regulatory information management (RIM), regulatory reporting, IDMP regulations, and data standards. Experience with emerging digital health technology in these settings is preferred.

• Deep knowledge of the system landscape used in regulatory affairs.

• Deep knowledge of software development using React, Node.js, and MarkLogic and configuration management.

• Practical knowledge of business analysis techniques to define and capture business value, user stories, workflows, and requirements.

• An innovative thinker with an understanding of intelligent automation and other technology trends and the potential impact on the J&J system portfolio.

• Understanding of the business and its operating environment (e.g., trends, competitors, compliance landscape, and regulatory environment).

• A delivery driver who utilizes robust project management to ensure timely delivery of projects that achieve expected benefits.

• Practical knowledge of computer systems validation requirements and all necessary compliance requirements for workflow, reporting, and information custody for medicinal products companies.

• Practical knowledge of agile development methodologies and experience with leveraging proof of concept techniques to test application of technologies to business cases.

• 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.

Qualifications

Education:

• A Bachelor's degree is required.

• A master's degree is preferred.

Experience and Skills:

• A minimum of 6 years of related experience in pharmaceutical development IT, 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.

• Business analysis experience, and a demonstrated capability to apply technology solutions in addressing complex, global business issues is required.

• Strong communication skills, and strong relationship development and management attributes in a global setting is required.

• Knowledge of current and new technologies including intelligent automation tools and their applicability to the business is required.

• Experience in project management and managing matrixed, consultant, and internal and external technical personnel in a fast-paced, complex, global project environment 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.

• Up to 10-15% travel (domestic & international) is required.

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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 .

Anticipated Salary Range: $118,000- $203,550

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Primary Location NA-US-New Jersey-Raritan

Other Locations NA-US-Pennsylvania-Spring House, NA-US-New Jersey-Titusville

Organization Janssen Research & Development, LLC (6084)

Travel Yes, 10 % of the Time

Job Function Technical Product Management

Req ID: 2406192765W