349456BR
Jul 22, 2022
India

Job Description

26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.

The Labeling Artwork Associate Manager is a subject matter expert for ‘US’ &
‘Universal Presentation’ related artwork activities for Novartis Innovative Medicine
products, and in addition, drives process improvement initiatives and provides
strategic guidance and training to Labeling Artwork Specialists. The main activities
are preparation, review, and approval of US & Universal Artwork, in coordination with
Country Organization (CO), CO QA, IPL authors and other stakeholders. This
position will also provide support for the required operational activities related to Global
Labeling. This position will support new product teams in planning and launching new
products and/or new indications to ensure compliance with artwork requirements.

Your Responsibilities:
Your responsibilities include but not are limited to:
• Responsible for end-to-end project management of new US & Universal artwork
creation for new product launches. Liaise with GLM, GPRM/GPRD, IPL authors, and relevant stakeholders to obtain required content and information for development of artwork.

• Lead, initiate and coordinate mock-up and text change requests, including safety label changes, for artwork in the ‘Artwork Change Request Tool’ based on the labeling/artwork standards, regulatory and requestor requirements.

• Support GPRMs/Product Managers and other stakeholders to align on regulatory. labeling artwork strategy in order to fulfil business objectives and smooth launch of new products.


• Review and approve Artwork in artwork tool using both manual and electronic methods. Approve the Printed Packaging Material Sheet (PPMS). Ensure final artwork accurately represents the approved text. Ensure consistency of across artwork (e.g., regulatory content, branding, as applicable) within a product family.

• Lead artwork projects affecting multiple products where collaboration and coordination across functions is required.Serve as Subject Matter Expert (SME) for issues and query resolution related to
Artwork Presentations.

• Ensure timely communication on projects and issues to key stakeholders and higher management.
Provide training and mentorship to new associates. Serve as SME in process development/improvement related to Artwork (e.g. SOPs, Working Practices, Working Instructions, etc.)

• Liaise with RA GPRDs, GPRMs and GLMs; Sub-Region Heads, CMC/TRD;Marketing; Package Engineers; Production Planning; Strategic Sourcing; third party co-marketing partners; and customer representatives concerning projects,scheduling, contracts, or operations, as required.

Diversity & Inclusion / EEO

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

Minimum Requirements

What You’ll bring to the role:

What You’ll bring to the role:

• Proficiency in English as a business language
• Science based BS or MS with requisite experience and demonstrated capability
• Experience: 6-8 years.
• Effective planning, organizational, and interpersonal skills. Computer skills (i.e., MS
• Office, etc.).
• Strong written and verbal skills. Ability to work with and/or lead project
• teams; multi-task. Knowledge/experience of regulations, guidelines.

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, 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 brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

https://talentnetwork.novartis.com/network
Global Drug Development
REG AFFAIRS GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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349456BR

Labeling Artwork Associate Manager

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