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

Description

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 selecte

Biotech developing enzyme replacement and gene therapies for rare genetic diseases. Headquartered in San Rafael, CA.

biomarin.com