Job Description

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
Job Function: R&D Product Development
Job Sub Function: R&D Software/Systems Engineering
Job Category: Scientific/Technology
All Job Posting Locations: IN022 Hyderabad
:
Johnson & Johnson Innovative Medicine R&D IT is seeking a Technical Product Owner, Regulatory Excellence Configuration Lead, located in Hyderabad, India. At Johnson & Johnson Innovative Medicine, we take patient safety and well-being into our core values. We bring together the best minds and pursue the most promising science.
The Technical Product Owner will help to craft the vision and prioritization of new technical features and/or improvements to a product to meet business needs. They will be accountable for technical delivery and value realization in partnership with the Technical Product Manager and Business Product Owner. They play a dual role as both the executor and ground-breaking behind the technical solutions. Their responsibilities include ensuring the product's technical architecture aligns with the technology roadmap and adheres to technical engineering standards.
The primary focus for this role will be on product analysis and configuration. This role will involve working in close collaboration with the Product team to define functional requirements that will be implemented on a unified regulatory platform. This role will be accountable for crafting the vision and prioritization of new technical features and improvements, ensuring that the product meets business needs effectively.
Key Responsibilities:

• Conduct detailed product analysis to understand capabilities and performance and maintain expertise in the unified regulatory platform capabilities.
• Collaborate with the Product team to clarify and detail functional requirements, translate business needs into specifications, and ensure backlog priorities align with business goals.
• Manage dependencies across teams and work closely with business and technical product team members to identify opportunities for operational efficiencies and compliance.
• Ensure that compliance requirements are met throughout the software development life cycle, maintaining up-to-date documentation and system configurations.
• Implement product configurations and contribute to testing and deployment of software solutions, including automation to improve solution quality.
• Configuration of URP business requirements, including workflows, document types, security, fields, page layouts, reports, dashboards, formatted output reports, and notifications.
• Leverage out-of-the-box or standard methodologies while meeting business requirements in the URP solution.
• Responsible for performing impact assessment on the current configuration and working with Technical Product Managers and Business Product Owners to make informed decisions in a timely manner for each product release.
• Drive user acceptance testing (UAT) by assisting in the design of test scripts and facilitating system demos and workshops to showcase product features and improvements.

Qualifications
Education:
Bachelor's or higher in Computer Science or similar (Engineering, Math, Physics, IT)
Experience and Skills:
Required:

• A minimum of ten (10) years of relevant IT and business experience in required
• Knowledge of global regulatory affairs, regulations, computer systems validation requirements, current industry regulatory technology landscape, including knowledge of vendors, systems and what is new & upcoming in this space and all vital compliance requirements for workflow, reporting, and information custody for medicinal products companies
• Experience in Testing, IT Project Management, Systems Support, IT Compliance, or associated track is required
• Experience gathering requirements and translating into a product vision by leveraging their expertise in product development, engineering and UX
• Deep understanding of business/processes and high-level understanding of high-quality digital product delivery. Practical knowledge of business analysis techniques to define and capture business value, user stories, workflows, and requirements.
• Experienced in managing a product backlog/release plan and tracking team level metrics. Experienced in developing systems and tools to enable customer requirements
• Prior track record of soliciting business requirements and converting them into functional and IT requirements
• Excellent understanding of Global Regulatory Affairs systems, processes, and system/data integrations with downstream systems for analytics, compliance, and dashboarding
• Strong verbal and written communication skills with ability to confidently present complex information to all levels of the organization is required
• Maintain and advance a positive team culture and support an authentic, open, and broad environment that improves diverse experiences and perspectives
• Understanding of customer journeys and customer experience
• Prior experience with pharmaceutical regulatory technologies like Documentum, Veeva, Calyx/Ennov RIM, Lorenz

Preferred:

• Experience in the use of Agile methodology, process engineering and prototyping tools
• Experience with Veeva RIM product suite

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.