Technical Product Owner – Regulatory Excellence Platform Lead

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:

Hyderabad, Andhra Pradesh, India

Job Description:

Johnson & Johnson Innovative Medicine R&D IT is seeking a Technical Product Owner, Platform Lead for Unified Regulatory Platform (URP), 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 Platform Lead for URP will manage the URP and integration infrastructure, leading activities such as VPN setup, SSO configuration, Azure account management, and other related services to ensure secure and efficient access to the URP SaaS platform, as well as to other internal and external integrations that will be part of the URP landscape. The Platform Lead will implement standard methodologies for network security and performance while collaborating with multi-functional teams to maintain platform stability and scalability.

Additionally, the Platform Lead will help craft the platform vision and prioritize new technical features and improvements to the products on the platform to meet regulatory business needs. They will be accountable for technical delivery and value realization together with the Technical Product Manager and Business Product Owner. They will ensure that the product's technical architecture aligns with the technological roadmap and adheres to established technical engineering standards.

Key Responsibilities:

• Perform end-to-end URP platform lifecycle activities including release management, delivery and performance management of the URP platform and integrations
• Collaborate with J&J IM Product Owners to build a technical backlog that delivers business value while meeting the needs of supporting teams
• Work in close partnership with the Regulatory architect and technology counterparts to lead cross-team dependencies in roadmaps and backlog
• Work with UPR platform vendor and Product Manager regarding capacity & product requirements on the platform and lay the foundation of scalable and high performing product
• Ensure platform fits into the broader Enterprise Architecture guidelines and standards (e.g., APIs, security controls, approved technologies, data standards, etc.) and maintain leading expertise on tech capabilities relevant to the platform
• Drive selection of platform solutions (e.g., AWS, Azure vs Google Cloud); work with the lead engineers to assess technical elements of the product
• In combination with engineering, develop high level solutions for platform features to enable product teams
• Ensure and facilitate Change Control and Risk Management Processes across the URP platform and Regulatory Excellence products
• Drive continuous improvement across URP platform and products through automation, measurements and standard methodologies
• Implement necessary IS security, GxP and other (compliance) items
• Provide support and point of escalation across all stages of the solution lifecycle including operational support and architecture optimization
• Responsible for defining and communicating a shared technical and architectural vision to ensure solution is fit for its intended purpose

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 is 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
• Excellent understanding of Global Regulatory Affairs systems, processes, and system/data integrations with downstream systems
• Experience leading the selection, building, and integration of platforms including Cloud Native technologies, data management, API architecture/design. Strong understanding and knowledge about cloud computing technologies and platforms
• Prior experience with pharmaceutical regulatory technologies like Documentum, Veeva, Calyx/Ennov RIM, Lorenz
• Deep understanding and experience in high quality digital delivery, including planning, dependency management, change control, risk, compliance and governance
• 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

Preferred:

• Experience in the use of Agile methodology
• 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.