Technical Product Owner, Regulatory Excellence Configuration Lead

Technical Product Owner, Regulatory Excellence Configuration Lead

Johnson & Johnson Innovative Medicine R&D IT is seeking a Technical Product Owner, Regulatory Excellence Configuration Lead, located in Raritan or Titusville, NJ. At Johnson & Johnson Innovative Medicine, we take patient safety and well-being into our core values. Redefining patient safety by finding new and better ways to collect, detect, assess, monitor, and prevent adverse events inspires us. We bring together the best minds and pursue the most promising science. The Technical Product Owner will help to shape the vision and prioritization of new technical features and/or enhancements 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 transformational behind the technical solutions. Their responsibilities include ensuring the product's configuration aligns with the business requirements and also adheres to technical engineering standards. The primary focus for this role will be on product analysis and configuration. This role will involve close collaboration with the Product team to define functional requirements that will be implemented on a unified regulatory platform. The successful candidate will be accountable for shaping the vision and prioritization of new technical features and enhancements, ensuring that the product meets business needs effectively.

Key Responsibilities

• Conduct thorough product analysis to understand capabilities and performance and maintain expertise in the unified regulatory platform offering.
• Collaborate with the Product team to clarify and document functional requirements, translate business needs into specifications, and ensure backlog priorities align with business objectives.
• Manage dependencies across teams and work closely with squad Product Owners, Product Managers, and business leaders to identify opportunities for operational efficiencies and compliance.
• Ensure that compliance requirements are met throughout the software development lifecycle, maintaining up-to-date documentation and system configurations.
• Implement product configurations and contribute to testing and deployment of software solutions, including automation to enhance solution quality.
• 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: 6 to 10 years of relevant IT and business experience
• Configuration experience with Veeva RIM product suite
• 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
• Experienced in managing a product backlog/release plan, tracking team level metrics, attend product team ceremonies, removing blockers
• 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
• Maintain and advance a positive team culture and support an authentic, open, and broad environment that enhances diverse experiences and perspectives
• Practical knowledge of business analysis techniques to define and capture business value, user stories, workflows, and requirements
• 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

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is $100,000 to $172,500. Additional Description for Pay Transparency: 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. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.