IT Senior Project Manager Regulatory Affairs
Job ID REQ-10033823
Jan 17, 2025
Spain
Summary
Location: Barcelona (Hybrid / Office)
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
The Project Manager for Regulatory Affairs (RA) team is responsible for capturing and addressing both global and local demands and projects from the RA business. This role involves close collaboration with other DDIT functions to ensure the delivery of high-quality services and innovative solutions to stakeholders. As a key contributor to the organization's strategy, the Project Manager will implement objectives related to technology strategy development, solution discovery, service management, risk management, and relationship management. In this role, the PM has to drive the development and implementation of cutting-edge solutions that leverage best-in-class technologies to enhance our products and services. PM is required to manage stakeholders and act as a strategic business partner.
About the Role
Major accountabilities:
* Identify project goals, objectives, and direction. Lead the project team by clearly setting expectations related to quality and performance.
* Deliver projects as per Novartis Standards.
* Follow the established IT Controls.
* Keep the costs within the approved budget.
* Support business stakeholders in identifying opportunities to streamline or improve processes through the implementation of innovative solutions to gain efficiencies.
* Stay up to date with the latest advancements in the IT Domain.
* Identify and evaluate opportunities to integrate technologies into our existing products and services.
* Work closely with the Business and DDIT stakeholders to understand their priorities and collaborate on the implementation of the defined roadmap for innovative solutions.
* Work closely with stakeholders to understand their needs and translate them into actionable projects.
* Be curious and engaged with our business stakeholders to establish a trustful and solid partnership.
* Manage relationships with internal and external stakeholders, including executives, business units, and partners.
* Act as a strategic business partner, providing guidance and insights on how the adoption of technologies can drive business growth and competitive advantage.
* Collaborate with external partners and stay engaged with the wider innovation community to leverage industry best practices. Monitor and evaluate the performance of implemented solutions, making iterative improvements as necessary.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
* Bachelor’s degree in engineering, pharmaceutical, computer science, management, or a related field. A Master's degree in a relevant discipline (MBA, MS, etc.) and related accreditations (IIBA, Veeva, Agile certifications, etc.) is a plus.
* At least 10+ years of experience in Project Management, preferably managing Digital & Automation projects within the Pharma domain.
* Excellent problem-solving and planning skills. A passion for innovation and a curiosity to explore technologies.
* Strong communication and presentation abilities, with the ability to effectively convey complex ideas to both technical and non-technical stakeholders.
* Experience in stakeholder management and strategic business partnering; working with cross-functional teams.
* Demonstrated ability to work in a fast-paced, dynamic environment and adapt to changing priorities.
* Must have proven strong knowledge of SDLC, Validation & Compliance.
* Proficiency with tools such as Jira, Confluence, HPQC, Business process modelling tools.
* Experience in Data migration and System integration related projects.
* Experience in managing GxP Projects and related fields.
* Multi-national global experience in interacting with senior management, collaborating across boundaries and relationship management, and influencing without authority.
* Budget Management, Commercial Acumen, Influencing Skills, Performance Management (PM), Risk Management, Service Delivery Management, Strategic Planning, Waterfall Project Management.
* Implementation experience of Veeva Submission and Registration module is a plus.
* Experience in Regulatory Affairs business processes is a plus (e.g. Registration Management, Submission Management, Submission Content management, Submission Publishing & Clinical Publishing, Product Labelling).
Languages:
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world.
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