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 good to have
• Experience of working in a matrix set-up as an individual contributor,
• demonstratable learning agility and ability deliver in tight timelines

 Skills:

• Medical regulatory writing.
• Regulatory label updates.
• Critical-path thinking.
• Good working knowledge of MS-office suite

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

 

With investments in new development capabilities, 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 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 supported! 

 

Join us!

Skills Desired

Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)