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 Join our Novartis Network Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up https talentnetwork novartis com network Advantages 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 Division Development Business Unit Innovative Medicines Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Alternative Location 1 Telangana India Functional Area Research Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to email protected and let us know the nature of your request and your contact information Please include the job requisition number in your message Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve

📌 Senior Transparency Associate For Clinical Trial Data (Telangana)
🏢 Novartis
📍 Telangana