Medical Manager

Job Description Summary Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Medical and clinical documentation during maintenance phase (e.g. Renewals, Variations, deficiency letters), including product Life Cycle Management activities. Providing Medical support to cross-functional teams viz, Global Labelling team for harmonization of Product labels. Providing a robust, scientific response document to support the Health Authority queries.

Job Description Your Key Responsibilities: Your responsibilities include, but not limited to:

• Timely renewal of the Marketing Authorizations as a part of the life cycle management activity of the products by providing documents viz.
• Clinical expert statements, non-clinical expert statements, addendum to clinical overviews.

• Providing support to the respond to the Deficiency letters received from the HA by preparing a literature-based robust scientific response document.
• Supporting the Global Labelling team in activities viz. harmonization of Product labels and Indication expansion activities.
• Providing quality documents with up-to-date scientific rigor supporting marketing authorisations; with minimal follow-up queries from stakeholders including HAs.

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