RA CMC Senior Manager Data & Digital

Oct 05, 2021

Job Description

582! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients’ lives and we need your help.

5,000 years of human history and yet more data was created in the last two years than ever before. Here at Novartis, our vision is to become the leading medicines company in the world powered by data and digital and transform our Regulatory Affairs CMC way of working.

Global RA CMC is at the forefront of the data and digital revolution in RA with major initiatives underway to evolve the way we manage our regulatory data and generate our dossiers in collaboration with the technical line functions as well as preparing for the implementation of ISO IDMP, PQ/CMC and the future of Structured Product Quality Submissions.

The RA CMC Senior Manager (Data & Digital) is a key organizational position which partners with colleagues across RA CMC, Regulatory Affairs, line functions and external interfaces to contribute to the implementation of disruptive digital technologies, digital roadmap and regulatory data standards and governance of RA CMC systems.

The RA CMC Senior Manager (Data & Digital) is a core team member of RA CMC and holds direct responsibility in the execution of relevant projects and activities ensuring implementation of the strategy. This requires the ability to influence and lead multi-disciplinary teams across a variety of subject matters and project management, to deliver with high quality, and in accordance with approved strategy.

Your Responsibilities include but are not limited to:

• Work with RA CMC members to help implement the strategy and governance of systems, data standards and automation
• Lead and contribute to projects and coordinating their activities with assigned SMEs and Technology Transformation partners to ensure the best fit to the RA CMC priorities and digital program strategy
• Ensure the successful adoption and scale-up of digital technologies across RA CMC
•Develop and nurture relationships with other functions and external partners to ensure the successful outcome of the assigned projects
• Contribute to opportunities where digital solutions can positively impact RA CMC operations and develop new or improved processes to increase efficiency, automation and quality of deliverables

Minimum Requirements

What You’ll Bring To The Role:

• Ability to communicate and influence effectively in a matrix environment, manage issues, resolve conflicts, and mitigate risks
• Good presentation skills with a proven track record of effectively communicating complex initiatives
• Good project management, planning, negotiation, organizational and interpersonal skills.
• Graduate degree or equivalent in life sciences (or MBA with bachelor’s degree, or equivalent experience in life science)
• Fluent English (oral and written)
• 5+ years industry experience
• 2+ years or equivalent multi-/cross-functional leadership experience
• Digital savviness and good understanding of technologies (e.g. big data, advanced analytics, AI, machine learning)
• Good understanding and direct relevant experience with digital technology and technical Pharmaceutical development
• Working knowledge/experience in regulatory CMC submission and approval processes
• Basic understanding of ISO IDMP, PQ/CMC and structured data submissions

Why consider Novartis?
799 million and counting. That’s how many lives our products touch, and while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.
Global Drug Development
Research & Development
Full Time
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RA CMC Senior Manager Data & Digital

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