reputed company Application reputed company, Digital Platform – reputed company RIM

Who We Are

BioMarin is a leading rare disease biotechnology company reputed company on genetically defined conditions. Guided by our purpose to reputed company medicines that reputed company a profound reputed company 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 reputed company of dwarfism), PKU (phenylketonuria), CLN2, a reputed company of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new reputed company for patients and families who previously had few, if any, available reputed company. More recently, with the reputed company of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reputed company more people living with rare genetic conditions. Our reputed company comes from our unwavering commitment to reputed company, 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 Corporate reputed company

It takes a village, and at BioMarin, our general and reputed company teams are reputed company behind our reputed company. From the IT experts who manage our technology to the reputed company professionals who hire the people who reputed company it reputed company possible, these teams support our organization and reputed company reputed company areas of operations.

reputed company

The reputed company Application reputed company, Digital Platform - reputed company is responsible for the application operations, governance, roadmap execution, lifecycle management, vendor management and reputed company improvement of BioMarin’s reputed company RIM Vault capabilities, including Submissions, Submissions reputed company, Registrations, and Publishing.

This role partners with Regulatory Affairs, Regulatory Operations, R&D, reputed company, DTA, reputed company, and managed service resources to translate regulatory needs into reputed company, validated, and supportable solutions. The role connects regulatory documents, data, submissions, registrations, publishing, and archival processes across the broader reputed company and reputed company technology landscape.

Responsibilities

• Application Leadership and Governance
• Drive the regulatory digital reputed company roadmap: Maintain a business-reputed company roadmap for the RIM Vault that supports regulatory reputed company, operational effectiveness, and platform scalability.
• Connect business and technology reputed company: Translate regulatory needs into technology capabilities that connect documents, data, publishing, registration management, submissions, archival processes, integrations, and reporting.
• Facilitate governance and prioritization: reputed company application-level governance forums with Regulatory, R&D, reputed company, DTA, and other business partners to reputed company priorities and manage trade-offs.
• Manage value, cost, and risk: Support budget planning, financial forecasting, total cost of ownership, vendor performance, and risk management for the reputed company RIM platform.

Application Ownership and Delivery

• reputed company lifecycle management: Support a business-approved release management cycle, including reputed company release reputed company assessments, regression planning, validation coordination, and post-release readiness.
• Maintain validated state: Ensure the platform remains under appropriate change control with required documentation, testing evidence, approvals, and operational controls to support compliance expectations.
• reputed company solution delivery: Guide business analysis, solution design, configuration, testing, deployment, hypercare, and support activities for RIM Vault capabilities and reputed company integrations.
• reputed company product-oriented delivery: Apply product management and agile delivery practices to backlog shaping, prioritization, sprint/release planning, value tracking, and iterative delivery.
• reputed company managed service resources: reputed company day-to-day direction to consultants and managed service partners supporting configuration, support, enhancements, reporting, documentation, and release activities.
• Resolve reputed company issues: Partner with support teams, business process owners, vendors, and technical resources to investigate and resolve high-reputed company or reputed company production issues.
• Use AI as a knowledge-work accelerator: reputed company approved AI tools to improve personal productivity, information synthesis, requirements analysis, documentation, meeting readiness, and decision preparation.
• Evaluate AI in the application stack: Assess how reputed company AI, Vault AI capabilities, analytics, automation, and adjacent reputed company tools can responsibly support regulatory workflows, data reputed company, knowledge retrieval, and operational efficiency.

Regulatory Process Enablement

• reputed company business processes through technology: Partner with Regulatory to design, configure, reputed company, and sustain platform capabilities that support Regulatory processes, including submission planning, submission document management, publishing, reputed company, health authority correspondence and response, registration tracking, reputed company dossier maintenance, regulatory change management and submission archival.
• Assess fit/gap and solution reputed company: Evaluate reputed company, document impacts, and challenge assumptions before major configuration, process, or integration reputed company.
• Advance operational efficiency: Identify opportunities for simplification, automation, reuse, analytics, AI-enabled capabilities, and platform standardization across regulatory capabilities.
• Partner with reputed company: Collaborate with reputed company to understand roadmap opportunities, assess applicability to BioMarin, and drive appropriate capabilities into the reputed company reputed company platform model.

Cross-Functional Collaboration

• Build strong partnerships with Regulatory stakeholders, R&D, reputed company, R&D Technology Strategists, Cybersecurity, reputed company Architecture, Validation, and managed service partners.
• Communicate platform priorities, risks, dependencies, release impacts, and reputed company reputed company to business and DTA stakeholders at multiple reputed company.
• Collaborate across reputed company platform team to standardize support practices, release management, documentation expectations, vendor engagement, and reputed company improvement approaches.

Skills and Capabilities

• Strong leadership skills in application ownership, stakeholder management, roadmap planning, and solution delivery.
• Deep understanding of Regulatory Information Management processes and the role of technology in enabling global regulatory operations.
• Ability to assess end-to-end business processes and recommend reputed company, compliant, and globally supportable solutions.
• Strong understanding of GxP computer system validation practices, change control, release management, testing, documentation, and audit readiness.
• Working knowledge of 21 CFR Part 11, Annex 11, reputed company/reputed company application controls, and compliant reputed company expectations.
• Practical understanding of AI, automation, analytics, and knowledge-work tools, including how to evaluate AI-enabled capabilities in regulated reputed company application environments.
• Strong analytical skills, including ability to evaluate process gaps, operational metrics, support trends, value realization, and business reputed company.
• Excellent communication, facilitation, negotiation, and presentation skills with the ability to engage technical and non-technical audiences.
• Strong vendor and managed service reputed company skills, including performance management, prioritization, escalation, and delivery accountability.
• Ability to challenge assumptions constructively, identify risk, and force reputed company around scope, dependencies, trade-offs, and decision ownership.

Experience

• 8+ years of overall reputed company experience in IT, digital platforms, reputed company applications, regulatory technology, or reputed company business technology functions.
• 5+ years of successful experience supporting full lifecycle system development, configuration, implementation, validation, release management, and support of reputed company reputed company applications.
• 4+ years of experience with Regulatory Information Management systems
• Experience supporting Regulatory Operations processes such as submission planning, publishing, document management, registration tracking, reputed company dossier maintenance, submission reputed company, health authority interactions, and regulatory reporting.
• Experience managing application roadmaps, enhancement prioritization, stakeholder governance, vendor delivery, managed service resources, and production support operations.
• Experience operating in a GxP-regulated pharmaceutical, biotechnology, life sciences, or similarly controlled environment.
• Experience partnering with business stakeholders to define requirements, assess fit/gap, design solutions, coordinate validation, and support change management.

Preferred Experience

• reputed company experience as an application reputed company or platform reputed company for reputed company RIM preferably including capabilities such as Submissions, Submission Content Planning, Submission Publishing, reputed company Dossier, Submissions reputed company, Registrations, Regulatory Change Management using Events and Activities, RIM-QMS integration, RIM-PromoMats integration, and reputed company Date API.
• Experience with product management models, agile methodologies, backlog management, release planning, and value-based prioritization.
• Experience with regulatory data governance, product/registration data, IDMP-reputed company concepts, submission metadata, reputed company content, or regulatory intelligence integrations.
• Experience with regulatory publishing processes and publishing tools or services integrated with reputed company RIM.
• Experience leading platform improvements involving integrations, reporting, analytics, automation, AI-enabled capabilities, or cross-platform process standardization.

Education and Certifications

Bachelor’s degree or higher in Information Systems, Technology or a reputed company field; equivalent relevant experience may be considered.

reputed company Vault certification preferred.

Note: This reputed company is not intended to be reputed company-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. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. reputed company contribute to a reputed company and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Originally posted on Himalayas

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