(CW) Business Systems Manager (IT Solutions Delivery Lead Contractor/Temp, Medical Affairs)

Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. About Worldwide Research and Development From research and discovery to post-market clinical development, our R D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. 100%REMOTE

CONTRACT/TEMPORARY

The IT Solutions Delivery Lead (Contractor/Temp, Medical Affairs) supports the delivery and ongoing operation of key Medical Affairs and R D-facing applications. Working under the direction of IT leadership and in partnership with business stakeholders, QA/CSV, and vendors, this role helps implement and improve validated systems, supports reliable operations, and contributes to evaluating next-generation solutions—including AI-enabled capabilities—while following compliance, security, and documentation expectations. Essential Duties and Responsibilities System Ownership  Support day-to-day application lifecycle activities (enhancements, upgrades, and issue resolution) to maintain reliable service and strong user experience.

• Coordinate with vendors and internal teams to manage support performance (tickets, SLAs, escalations) and drive timely issue resolution.
• Support financial administration activities for assigned systems (e.g., tracking invoices, license counts, and renewal inputs) in coordination with IT leadership.
• Support stakeholder alignment and routine governance activities (e.g., meeting coordination, action/decision tracking, change control coordination) and help translate business needs into clear requirements.
• Support compliance and operational readiness through disciplined documentation, risk/issue tracking, and adherence to validated processes and SOPs. Project Delivery  Support application implementations and upgrades using SDLC best practices (requirements, design, build/config coordination, test support, release readiness, and hypercare).
• Assist with requirements gathering and solution design workshops; document requirements/user stories and contribute to solution options and estimates.
• Coordinate with QA/CSV to support validated delivery (e.g., validation planning inputs, traceability support, test evidence collection, and UAT coordination).
• Maintain project artifacts (plans, RAID logs, action items) and provide regular status updates; help track milestones, risks, and dependencies.
• Support vendor evaluation activities (including AI-enabled offerings) by gathering inputs and assessing considerations such as compliance, security/privacy, data readiness, scalability, and operational fit.
• Use AI responsibly to accelerate analysis tasks (e.

g., requirements synthesis, document review, decision support) under team guidance. Apply prompt engineering and basic evaluation methods to improve output quality and traceability in line with compliance expectations. System Administration  Provide operational administration and support for assigned applications, ensuring reliability and a positive end-user experience.

• Track and coordinate incidents, problems, and enhancements (prioritization support, root cause follow-up, and continuous improvement actions) with vendors and internal SMEs.
• Support maintenance of validated/qualified state in alignment with QA/CSV policies (documentation support, change control coordination, and periodic review inputs).
• Support operational procedures (monitoring checks, access management requests, upgrades, and communications for outages/changes) following established processes.
• Assist with reporting and basic scorecards to monitor service health and selected business metrics. Skills and Attributes  Stakeholder partnership: Builds strong relationships across business, QA/CSV, and IT; communicates clearly and sets expectations.
• Analytical problem solving: Breaks down ambiguous problems, uses data to drive decisions, and proposes pragmatic options.
• Delivery leadership: Plans work, manage risks/dependencies, and drive cross-functional execution in a regulated environment.
• Technical breadth: Experience supporting business applications, integration, and vendor-hosted (SaaS) solutions; comfortable troubleshooting and coordinating SMEs.
• AI capability: Working knowledge of generative AI/LLMs and AI-assisted analytics; experience with prompt engineering, output evaluation, and use of controls (privacy, security, auditability) appropriate for regulated use.
• Vendor assessment: Ability to review and challenge vendor claims (including AI); assess data needs, governance, validation implications, monitoring, and change management for solutions supporting large workstreams. Qualifications Required  Bachelor's degree in a technical discipline (or equivalent experience).
• 5+ years of experience in IT solution delivery, system ownership, business analysis, or a similar role supporting enterprise applications.
• Experience delivering projects in a regulated/validated environment, including partnership with QA/CSV and participation in change control.
• Strong vendor management experience (SaaS providers, integrators, and support partners), including SLA and budget management.
• Experience supporting Medical Affairs, Clinical, or R D functional systems in Pharma/BioTech. Preferred
• Hands-on experience using generative AI/LLM tools, including prompt engineering and practical evaluation of outputs (quality, consistency, and traceability).
• Ability to evaluate AI-enabled vendor solutions for large workstreams, considering data governance, security/privacy, compliance, scalability, and operational readiness.
• Familiarity with common Pharma/BioTech platforms and data flows (e.g., safety, medical information, content, analytics/reporting).
• Experience with integration patterns and reporting/analytics tools (e.g., data pipelines, dashboards, scorecards).
• Experience building lightweight AI evaluations (test sets, acceptance criteria, human-in-the-loop review) for regulated use cases.

Note:

This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.