Medical Manager

Sandoz India; Telangana; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Sandoz India is seeking a medical writer to support regulatory submissions and lifecycle management for its pharmaceutical products. You will prepare clinical/non-clinical expert statements, respond to deficiency letters, and contribute to labeling harmonization with a strong emphasis on scientific rigor.

The role requires a medical background, understanding of drug development, and 2–3 years of medical writing experience in a matrix environment, with the ability to deliver within tight

Qualifications

• 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.

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 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.

Skills

Medical regulatory writing

Regulatory label updates

Critical-path thinking

MS Office

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.

Essential Requirements

What you’ll bring to the role:

• 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

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.

Essential Requirements

What you’ll bring to the role:

• 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!