Global Labeling Manager (GLM), Safety Label Updates

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!
Provides the labeling/artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides strategic labeling input and support for global development projects and/or marketed products. Reviews labeling change information, and ensures that it is supported by the data and consistent with the application. Supports and assists the development and participates in negotiations on later stage products with regulatory agencies on approval of label. Monitors, evaluates and recommends improvements to labeling processes, quality, systems tools and/or policies.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Identifies new safety information from defined sources, e.g. health authority webpages, email received at generic mailbox and updates to reference product information.
• Pre-evaluates detected or otherwise collected information and enters it in the signal management tracking system cdsDB.
• Performs signal evaluation and assess signals under guidance of Global Labeling Manager.
• Supports timely creation of CDSs required for assigned products.
• Prepares and revises working instructions concerning safety label updates.
• Provides Guidance and has oversight on the tasks assigned to the Associates/Specialists within the Global Labelling Team.
•   Assess and Enable Digital Solutions for safety databases to improve efficiency in screening of safety information across various data sources.
•   Supports Audits/Inspection on Safety Label Screening and SOP/WP authoring as an SME (Subject Matter Expert). 
• Contribute and/or review metrics for Safety Label Screening milestone

What you’ll bring to the role:Essential Requirements:

• Degree in Health Sciences or higher, including medical degree, pharmacy, or nursing

• Minimum 10+ years in safety labelling requirements

• Cross Cultural Experience.
• People Challenges.
• Functional Breadth.
• Project Management.
• Collaborating across boundaries.

Skills:

• Cross-Functional Teams.
• Detail Oriented.
• Labeling Documentation.
• Labeling Regulations.
• Operational Excellence.
• Regulatory Compliance.
• Safety.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

The future is ours to shape!

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.

Skills Desired

Cross-Functional Teams, Detail-Oriented, Labeling Documentation, Labeling Regulations, Operational Excellence, Regulatory Compliance, Safety