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IT Senior Project Manager Regulatory Affairs

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Novartis

10d ago

  • Job
    Full-time
    Expert Level
  • Consulting
    Business, Operations & Strategy
  • Barcelona

AI generated summary

  • You need a relevant Bachelor's degree, 10+ years in IT project management in Pharma, strong SDLC knowledge, proficiency in tools like Jira, and experience in regulatory affairs and GxP projects.
  • You will lead projects, set goals, manage budgets, optimize processes, collaborate with stakeholders, integrate technologies, and monitor solution performance for continuous improvement.

Requirements

  • 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 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.
  • 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).
  • English.

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
  • 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
  • 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

FAQs

What is the location for this job role?

The location for this job role is Barcelona, in a hybrid/office format.

Is relocation support available for this position?

No, Novartis is unable to offer relocation support for this role.

What are the major responsibilities of the IT Senior Project Manager in Regulatory Affairs?

The major responsibilities include identifying project goals, delivering projects according to Novartis standards, managing stakeholder relationships, supporting business stakeholders in process improvements, and implementing innovative solutions.

What qualifications are required for this position?

A Bachelor’s degree in engineering, pharmaceutical, computer science, management, or a related field is required. A Master’s degree and relevant accreditations are a plus.

How many years of experience are required for this role?

At least 10+ years of experience in Project Management, preferably managing Digital & Automation projects within the Pharma domain, is required.

What skills are essential for the IT Senior Project Manager position?

Essential skills include excellent problem-solving and planning abilities, strong communication and presentation skills, stakeholder management, budget management, and knowledge of SDLC, Validation & Compliance.

Is knowledge of specific tools required for this role?

Yes, proficiency with tools such as Jira, Confluence, HPQC, and business process modeling tools is required.

What type of projects will the IT Senior Project Manager be managing?

The PM will manage digital & automation projects, data migration, system integration, and GxP projects.

Are there any desirable qualifications or experiences for this position?

Yes, implementation experience of the Veeva Submission and Registration module and experience in Regulatory Affairs business processes are considered desirable.

What languages are required for this role?

Proficiency in English is required.

What is Novartis’s commitment regarding diversity and inclusion?

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities they serve.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right