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 Corporate Groups
It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.
Description
The Principal Application Lead, Digital Platform - Veeva is responsible for the application operations, governance, roadmap execution, lifecycle management, vendor management and continuous improvement of BioMarin’s Veeva RIM Vault capabilities, including Submissions, Submissions Archive, Registrations, and Publishing.
This role partners with Regulatory Affairs, Regulatory Operations, R&D, Quality, DTA, Veeva, and managed service resources to translate regulatory needs into scalable, validated, and supportable solutions. The role connects regulatory documents, data, submissions, registrations, publishing, and archival processes across the broader Veeva and enterprise technology landscape.
Responsibilities
- Application Leadership and Governance
- Drive the regulatory digital Veeva roadmap: Maintain a business-aligned roadmap for the RIM Vault that supports regulatory strategy, operational effectiveness, and platform scalability.
- Connect business and technology strategy: Translate regulatory needs into technology capabilities that connect documents, data, publishing, registration management, submissions, archival processes, integrations, and reporting.
- Facilitate governance and prioritization: Oversee application-level governance forums with Regulatory, R&D, Quality, DTA, and other business partners to align 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 Veeva RIM platform.
Application Ownership and Delivery
- Lead lifecycle management: Support a business-approved release management cycle, including Veeva release impact 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.
- Oversee solution delivery: Guide business analysis, solution design, configuration, testing, deployment, hypercare, and support activities for RIM Vault capabilities and related integrations.
- Lead product-oriented delivery: Apply product management and agile delivery practices to backlog shaping, prioritization, sprint/release planning, value tracking, and iterative delivery.
- Direct managed service resources: Provide day-to-day direction to consultants and managed service partners supporting configuration, support, enhancements, reporting, documentation, and release activities.
- Resolve complex issues: Partner with support teams, business process owners, vendors, and technical resources to investigate and resolve high-priority or complex production issues.
- Use AI as a knowledge-work accelerator: Leverage 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 Veeva AI, Vault AI capabilities, analytics, automation, and adjacent enterprise tools can responsibly support regulatory workflows, data quality, knowledge retrieval, and operational efficiency.
Regulatory Process Enablement
- Enable business processes through technology: Partner with Regulatory to design, configure, integrate, and sustain platform capabilities that support Regulatory processes, including submission planning, submission document management, publishing, dispatch, health authority correspondence and response, registration tracking, active dossier maintenance, regulatory change management and submission archival.
- Assess fit/gap and solution options: Evaluate options, document impacts, and challenge assumptions before major configuration, process, or integration decisions.
- Advance operational efficiency: Identify opportunities for simplification, automation, reuse, analytics, AI-enabled capabilities, and platform standardization across regulatory capabilities.
- Partner with Veeva: Collaborate with Veeva to understand roadmap opportunities, assess applicability to BioMarin, and drive appropriate capabilities into the enterprise Veeva platform model.
Cross-Functional Collaboration
- Build strong partnerships with Regulatory stakeholders, R&D, Quality, R&D Technology Strategists, Cybersecurity, Enterprise Architecture, Validation, and managed service partners.
- Communicate platform priorities, risks, dependencies, release impacts, and decisions clearly to business and DTA stakeholders at multiple levels.
- Collaborate across Veeva platform team to standardize support practices, release management, documentation expectations, vendor engagement, and continuous 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 scalable, 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, SaaS/cloud application controls, and compliant system support expectations.
- Practical understanding of AI, automation, analytics, and knowledge-work tools, including how to evaluate AI-enabled capabilities in regulated enterprise application environments.
- Strong analytical skills, including ability to evaluate process gaps, operational metrics, support trends, value realization, and business impact.
- Excellent communication, facilitation, negotiation, and presentation skills with the ability to engage technical and non-technical audiences.
- Strong vendor and managed service oversight skills, including performance management, prioritization, escalation, and delivery accountability.
- Ability to challenge assumptions constructively, identify risk, and force clarity around scope, dependencies, trade-offs, and decision ownership.
Experience
- 8+ years of overall professional experience in IT, digital platforms, enterprise applications, regulatory technology, or related business technology functions.
- 5+ years of successful experience supporting full lifecycle system development, configuration, implementation, validation, release management, and support of enterprise SaaS applications.
- 4+ years of experience with Regulatory Information Management systems
- Experience supporting Regulatory Operations processes such as submission planning, publishing, document management, registration tracking, active dossier maintenance, submission archive, 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
- Direct experience as an application owner or platform lead for Veeva RIM preferably including capabilities such as Submissions, Submission Content Planning, Submission Publishing, Active Dossier, Submissions Archive, Registrations, Regulatory Change Management using Events and Activities, RIM-QMS integration, RIM-PromoMats integration, and Direct 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-related concepts, submission metadata, structured content, or regulatory intelligence integrations.
- Experience with regulatory publishing processes and publishing tools or services integrated with Veeva 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 related field; equivalent relevant experience may be considered.
Veeva Vault certification preferred.
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.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
