Manager, Global Development Systems

The Technical System Manager is a key member of the Global Development (GD) Solutions organization, who is responsible for key activities in handling Global Development Systems Build and Run, focusing on GRA (Global Regulatory Affairs). The position requires domain expertise in “Global Development” Regulatory processes and technologies (like Veeva Vault RIM, Lorenz Publishing suite, Electronic Document Management Systems etc.). This individual is the right-hand team member for the GRA System Owner, interacts with business Subject Matter Experts (SMEs) and Corporate IT on the day-to-day basis in support of systems and projects. The role requires excellent business and technical analysis skills and business domain knowledge. This individual partners with Global Development Solutions and Business Personnel in understanding business challenges and proposes solutions and provides leadership on support and projects to maintain existing solutions and transitioning new solutions.

The Technical System Manager (TSM) for Regulatory Systems, will provide technical administration and operational system support for projects and a portfolio of applications enabling the Regeneron GRA teams.

• Responsible for ensuring day-to-day Run operational support to meet business expectations and compliance requirements.
• Vital to the implementation of new systems and upgrades of existing systems. Effectively handle business user expectations, timelines, and budget.
• Work with outsourced Managed Service technical support vendor personnel to maintain and transition solutions.
• Works collaboratively with Corporate IT in the management of enterprise systems, the development and alignment to standards and governance, enterprise architecture and common infrastructure
• Understands Global Development “Regulatory” business domain and/or technology very well and can analyze business challenges and present technology solutions.
• Keeping abreast of technology trends and applicability to business needs.
• Contributes on simple projects in roles such as Business Analyst and or Solution Architect etc.
• Ability to elicit and gather requirements
• Ability to create simple contextual or system diagrams to illustrate the future state solution and create UAT scripts and coordinate testing
• Ensures the standard and compliant support of non-GxP systems.
• Ability to take on multiple assignments and work independently, with minimal direction on task implementation.
• Align with all GRA Regulatory Systems SOPs in the support of GD systems.

Bachelor's degree required and 7+ years’ experience managing complex high-impact IT projects from start to finish and supporting and Administrating Global Regulatory Solutions

• ITIL certifications
• Veeva Vault Administrator
• Experience in Veeva Vault or any EDMS Systems, Lorenz or any Regulatory Publishing tools.
• Coordination of OS patching where needed
• Incident management (Dev, Test, Prod) where needed
• Proactive system monitoring for performance
• Perform standard housekeeping activities to ensure efficient performance of systems
• Update of bug fixes/improvements required to support the business
• Build & Maintain operational run book for Global Development Systems
• Design improvements to ensure scalability of All Global Development Systems as needed.
• Support for application upgrades
• Application maintenance for All Global Development Solutions “Patching, etc..)
• Application configuration/development related to All Global Development solutions
• GXP Change Control Management
• Experience in performing validation activities for GXP systems
• Create & Maintain Interfaces where required
• Maintain Domain Knowledge
• Experience managing complex high-impact IT projects from start to finish and supporting and Administrating Global Regulatory Solutions
• Good understanding of Regulatory business processes
• Ability to effectively manage multiple priorities with a sense of urgency
• Attention to detail and accuracy of work
• Strong knowledge of business analysis, system design and producing quality documentation
• Strong problem solving, technical writing and verbal communication skills
• Strong knowledge of SDLC methodologies
• Strong knowledge of GXP and 21 CFR Part 11 Compliance
• Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio)
• Experience with ServiceNow and Jira Experience on core ITIL processes

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.