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:

• Candidate must have medical background and a good understanding of medical and pharmacological fundamentals
• Understanding of fundamentals of drug development and drug life-cycle management
• 2-3 years of medical writing/ regulatory medical writing experience; responding to HA queries/ deficiency letters; exposure to writing for peer reviewed journals is valuable to have
• Experience of working in a matrix set-up as an individual contributor,
• d

📌 Medical Manager (India)
🏢 Sandoz
📍 India