Medical Manager

IN04 (FCRS = IN004) Sandoz Private Limited; Telangana; Presencial; INR 900 000 - 1 500 000; Tempo integral

Resumo da oferta

Sandoz is seeking a Medical Writer to support regulatory medical writing activities during maintenance phases, including renewals, variations, and deficiency letters. You will contribute to lifecycle management, respond to Health Authority queries, and assist the Global Labelling team with label harmonization and indication expansion.

Essentially, you will deliver scientifically rigorous documentation and support cross-functional teams to ensure timely approvals, while maintaining strong MS

Qualificações

• Medical regulatory writing experience
• Experience with regulatory labeling
• Analytical thinking and problem solving

Responsabilidades

• Timely renewal of Marketing Authorizations as part of lifecycle management
• Prepare literature-based robust scientific responses to deficiency letters from Health Authorities
• Support Global Labelling team in product label harmonization and indication expansion
• Produce quality documents with up-to-date scientific rigor to minimize HA queries

Conhecimentos

Medical regulatory writing

Regulatory label updates

Critical-path thinking

MS Office

Descrição da oferta de emprego

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.

Your Key Responsibilities

• 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 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)

Our Purpose here at Sandoz

Here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!