Senior Transparency Associate for Clinical Trial Data

Novartis

5 - 10 years

Hyderabad

Posted: 01/08/2025

Job Description

Summary

-Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets & enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

About the Role

Major accountabilities:

Manages medium to small level global regulatory submission projects.
Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
Frequent internal company and external contacts.
Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

Adherence to Novartis policy and guidelines -Project & stakeholder feedback

Minimum Requirements:
Work Experience:

Cross Cultural Experience.
Functional Breadth.
Collaborating across boundaries.
Operations Management and Execution.
Project Management.

Skills:

Clinical Study Reports.
Data Analysis.
Documentation Management.
Lifesciences.
Operational Excellence.
Regulatory Compliance.

Languages :

English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

About Company

Novartis is a leading global healthcare company headquartered in Basel, Switzerland. It specializes in the research, development, manufacturing, and marketing of innovative pharmaceuticals. Formed in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis focuses on areas such as oncology, neuroscience, immunology, cardiovascular diseases, and gene therapies.With a strong commitment to scientific innovation, Novartis invests heavily in R&D and collaborates with biotech companies and academic institutions worldwide. The company operates in over 140 countries and serves millions of patients globally. Novartis is also known for its efforts in access to medicine, using programs like Novartis Access and Novartis Foundation to support underserved populations.