IT Solutions Delivery Lead Regulatory and Medical Affairs

Profile

Who We Are It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin. About the OpportunityThe IT Solutions Delivery Lead, Regulatory and Medical Affairs role is critical to ensuring successful development and delivery of Information Technology strategies which emphasize the IT organization\u2019s leadership role in \u201Cmanaging information technology\u201D which includes System Ownership for the WWRD organization\u2019s systems which allow the business to focus on what they are best at.The WWRD organization is responsible for everything from research and discovery to post-market clinical development. Our customers include Research, Clinical Sciences, BioMetrics, Clinical Development/Operations, Pharmacovigilance, Regulatory, Medical Affairs, etc.\u00A0 Your focus will be on Regulatory and Medical Affairs business units.The position will maintain full time engagement to the WWRD business unit and continually capture and examine the unique needs and concerns of the business to manage the standard support practices and procedures for identifying, scoping, developing, testing and releasing/publishing WWRD business systems.\u00A0 The position will provide system support, maintenance, licensing, data management and project delivery for the life of their systems.Will be an integral part of global WWRD IT Solution Delivery and Support team, with responsibility for developing, maintaining, monitoring, and supporting an industry specific set of Regulatory and Medical Affairs systems.\u00A0 Will work closely with the business SMEs and IT project managers to capture and\u00A0prioritize all requests for the WWRD business unit and address and/or escalate any data, process and technical issues that inhibit the vision and enhanced efficiencies of the business needs and change.\u00A0Essential Duties and ResponsibilitiesSystem Ownership Lifecycle Management of applications to deliver business capabilities while ensuring efficient allocation of resources across our technology landscape. Financial responsibility of all system operational expenses. Manage Software Vendors to ensure SLAs are met and system is up to date. Manage Licensing for your systems including budgeting and growth forecasting. Facilitate Application Steering Committees to maximize value delivered by applications and always improve UX. Participate on change control boards and design review committees. Bridge the gap between the business needs and technology constraints to develop the right strategy/solution for the company.Project DeliverySupport new application and system deployment projects with an emphasis on the software development life cycle (SDLC).Participate as subject matter expert (and in some cases lead) projects with project managers, technicians and business analysts.Develop and implement technical strategies for various validated/qualified laboratory computer systems with an emphasis on global enterprise systems. Partner with the business team to implement next-gen applications and to upgrade existing applications. Develop Solution Options based on user requirements including level of effort and costs estimates. Champion internal IM standards and best practices during the design/implementation phase of a project. Provide analytical support for multiple complex projects; establish work plans and timelines; co-ordinate with internal and external sources. Organize technical requirements gathering and solution design sessions with customers, partners, and other technical resources of all levels. Developing support plan and ensuring smooth turnover to operations.System Administration Responsible for managing, administering and configuring Business Applications through the System Development Lifecycle. Manage Vendors and Service Providers to ensure system support needs are met. Provide technical guidance to peers, contingent staff, and support vendors. Communicate system outages, changes and overall status to key business stakeholders. Maintains systems under department control in qualified state by establishing and enforcing platform standards aligning with Quality Assurance and Computer System Validation policy, along with Health Authority regulations.Develop and administer system procedures for installation, monitoring, performance utilization, upgrades, backups, recovery and overall operations in a validated environment. Develops and maintains reports, scorecards and tools to enable regular business monitoring of system key indicators.Provide tier 3\u00A0developer support for your systems, e.g., root cause analysis, working with vendor support, working with IT technology SME's to resolve issues. Prioritize and support WWRD related incident/service tickets related to owned systems. Continuous improvement of support processes. Track, prioritize and fulfill all system enhancement requests. Plan, build, deploy, secure, integrate, and support application solutions for WWRD. Work schedule may include \u2018out of normal\u2019 work hours for IT support & maintenance.Skills and Attributes Decision Making: The ability to make sound and effective decisions from all available information. Collaboration: Seek the perspective of others and partner with others across and outside the organization to define and reach a shared goal. Persuade by effectively sharing information. Influence based on credibility and earning the respect of others. Agility and Problem Solving: An adaptable and flexible attitude, allowing you to approach and solve a problem by examining it from different angles. Strongly developed problem-solving skills are crucial in this role. Leadership: Strong Leadership Skills in Project Definition, Mitigation and overall Delivery. Ability to provide constructive feedback to vendors and service providers.\u00A0 Ability to set technical direction to project teams and upper management for your systems. Organization: This role demands high level organizational skills as you will be managing all aspects of your systems from build and maintain to financial accrual and forecasting. Communication: Systems analysts use various forms of written and verbal communication to gather information about a problem and propose solutions. Analysts are required to communicate with team members of all levels. Technical: Technical skills are also important in the Systems Analyst role. Upgrading, troubleshooting and implementing new software programs are some of the requirements of a systems analyst. Project management: The System Analyst often works in a project team environment. Strongly developed organizational and time management skills are important to move a project from start to finish.Education and Experience Bachelor of Science or greater in Computer Science, Business Administration, Information Technology, Biology, Chemistry or a related technical field or significant experience in supporting research systems in the pharmaceutical industry. Have a general knowledge of the underlying scientific principles applied to the development and manufacture of biopharmaceuticals. Experience in computer database management, programming, or software development familiar with developing Power Apps and Power Automate. Desire minimum 5 years\u2019 experience in technical or business analyst role with a focus on WWRD functional systems and/or information management. Familiarity with Pharma/BioTech R&D systems such as Insight Publisher, DocuBridge, Global Submit Validate, etc. Delivering mid-to-large size projects with teams of 5 to 15 members on time and under budget. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Company info

BioMarin Pharmaceutical Inc.
Website : http://www.biomarin.com