Novartis

Job Description Summary

• 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 must 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.

Job Description

Roles and Responsibilities:

• 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 and Keeping the costs within the approved budget.
• Support business stakeholders on 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 IT Domain and Identify and evaluate opportunities to integrate the 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.

Essential Requirements:

• At least 10+ years of experience in Project Management, preferably managing Digital & Automation projects within 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.
• Excellent communication skills.
• Must have proven strong knowledge of SDLC, Validation & Compliance, Agile methodology
• Proficiency with tools such as Jira, Confluence, HPQC, MS Project, Smartsheets and other project management 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

Desirable:

• 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)

Education & Qualifications:

• 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 in project management, agile, quality and compliance is a plus.

Skills Desired

Change Management, Decision Making Skills, Project Finance, Project Risk Management, Project Team Management, Stakeholder Engagement, Waterfall Model