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

BioMarin Pharmaceutical Inc

San Rafael, CA

JOB DETAILS
SKILLS
Acceptance Testing, Administrative Skills, Adverse Events, Agile Programming Methodologies, Alliance/Partner Marketing, Analysis Skills, Application Integration, Artificial Intelligence (AI), Best Practices, Billing, Biotech and Pharmaceutical, Budget Management, Business Analysis, Business Solutions, Change Control, Change Management, Clinical Research, Clinical Trial, Communication Skills, Continuous Improvement, Cross-Functional, Data Analysis, Data Management, Decision Support, Disease, Documentation, Documentation Review, Drug Development, Enterprise Applications, Establish Priorities, Facebook, Fellowship, Financial Administration, Genetics, Identify Issues, Information Technology & Information Systems, Information/Data Security (InfoSec), Leadership, LinkedIn, Maintain Compliance, Management of Information Systems/Technology (MIS), Manufacturing, Medical Affairs, Medical Products, Medical Records, Metrics, Needs Assessment, Newsroom, Operational Support, Operations Processes, Performance Management, Plan Meetings, Press Releases, Privacy Controls, Problem Solving Skills, Process Development, Productivity Management, Publications, Quality Assurance, Quality Management, RAID Storage, Recruiting/Staffing Agency, Reporting Dashboards, Requirements Management, Research & Development (R&D), Risk, Risk Management, Scorecarding, Service Level Agreement (SLA), Software Administration, Software Development Lifecycle (SDLC), Software Upgrades, Software as a Service (SaaS), Standard Operating Procedures (SOP), Supply Chain, Support Documentation, System Validation, Systems Administration/Management, Technical Leadership, Testing, Time Management, Traceability, Use Cases, User Interface/Experience (UI/UX), Validation Plan, Vendor/Supplier Evaluation, Vendor/Supplier Management
LOCATION
San Rafael, CA
POSTED
15 days ago

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

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Location: San Rafael, United States

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Workstyle: Remote Only

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Apply

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Who We Are

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BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s 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.

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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.

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About Worldwide Research and Development

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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.

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100%REMOTE CONTRACT/TEMPORARY

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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 solutionsxe2x80x94including AI-enabled capabilitiesxe2x80x94while following compliance, security, and documentation expectations.

Essential Duties and Responsibilities

System Ownership

xefx82xa7 Support day-to-day application lifecycle activities (enhancements, upgrades, and issue resolution) to maintain reliable service and strong user experience.

xe2x80xa2 Coordinate with vendors and internal teams to manage support performance (tickets, SLAs, escalations) and drive timely issue resolution.

xe2x80xa2 Support financial administration activities for assigned systems (e.g., tracking invoices, license counts, and renewal inputs) in coordination with IT leadership.

xe2x80xa2 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.

xe2x80xa2 Support compliance and operational readiness through disciplined documentation, risk/issue tracking, and adherence to validated processes and SOPs.

Project Delivery

xefx82xa7 Support application implementations and upgrades using SDLC best practices (requirements, design, build/config coordination, test support, release readiness, and hypercare).

xe2x80xa2 Assist with requirements gathering and solution design workshops; document requirements/user stories and contribute to solution options and estimates.

xe2x80xa2 Coordinate with QA/CSV to support validated delivery (e.g., validation planning inputs, traceability support, test evidence collection, and UAT coordination).

xe2x80xa2 Maintain project artifacts (plans, RAID logs, action items) and provide regular status updates; help track milestones, risks, and dependencies.

xe2x80xa2 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.

xe2x80xa2 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

xefx82xa7 Provide operational administration and support for assigned applications, ensuring reliability and a positive end-user experience.

xe2x80xa2 Track and coordinate incidents, problems, and enhancements (prioritization support, root cause follow-up, and continuous improvement actions) with vendors and internal SMEs.

xe2x80xa2 Support maintenance of validated/qualified state in alignment with QA/CSV policies (documentation support, change control coordination, and periodic review inputs).

xe2x80xa2 Support operational procedures (monitoring checks, access management requests, upgrades, and communications for outages/changes) following established processes.

xe2x80xa2 Assist with reporting and basic scorecards to monitor service health and selected business metrics.

Skills and Attributes

xefx82xa7 Stakeholder partnership: Builds strong relationships across business, QA/CSV, and IT; communicates clearly and sets expectations.

xe2x80xa2 Analytical problem solving: Breaks down ambiguous problems, uses data to drive decisions, and proposes pragmatic options.

xe2x80xa2 Delivery leadership: Plans work, manage risks/dependencies, and drive cross-functional execution in a regulated environment.

xe2x80xa2 Technical breadth: Experience supporting business applications, integration, and vendor-hosted (SaaS) solutions; comfortable troubleshooting and coordinating SMEs.

xe2x80xa2 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.

xe2x80xa2 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.

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Qualifications

Required

xefx82xa7 Bachelorxe2x80x99s degree in a technical discipline (or equivalent experience).

xe2x80xa2 5+ years of experience in IT solution delivery, system ownership, business analysis, or a similar role supporting enterprise applications.

xe2x80xa2 Experience delivering projects in a regulated/validated environment, including partnership with QA/CSV and participation in change control.

xe2x80xa2 Strong vendor management experience (SaaS providers, integrators, and support partners), including SLA and budget management.

xe2x80xa2 Experience supporting Medical Affairs, Clinical, or R&D functional systems in Pharma/BioTech.

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Preferred

xe2x80xa2 Hands-on experience using generative AI/LLM tools, including prompt engineering and practical evaluation of outputs (quality, consistency, and traceability).

xe2x80xa2 Ability to evaluate AI-enabled vendor solutions for large workstreams, considering data governance, security/privacy, compliance, scalability, and operational readiness.

xe2x80xa2 Familiarity with common Pharma/BioTech platforms and data flows (e.g., safety, medical information, content, analytics/reporting).

xe2x80xa2 Experience with integration patterns and reporting/analytics tools (e.g., data pipelines, dashboards, scorecards).

xe2x80xa2 Experience building lightweight AI evaluations (test sets, acceptance criteria, human-in-the-loop review) for regulated use cases.

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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.

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Equal Opportunity Employer/Veterans/Disabled

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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.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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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.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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About the Company

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BioMarin Pharmaceutical Inc