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About NOVARTIS

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Find out more at https://www.novartis.com See our community guidelines: https://go.novartis.social/4bqbjuA

Global Head Procurement - Real Estate & Facility Services

Hyderabad

10 - 15 years

INR 30.0 - 35.0 Lacs P.A.

Work from Office

Full Time

Summary The role is accountable for driving and implementing the REFS Procurement strategic goals at global level levels and successfully managing relevant KPIs regarding productivity, compliance metrics, processes, customer satisfaction, and people development. The role is also responsible for successfully managing and developing relationships and effective demand management with senior stakeholders, driving value for their business across the organization, and with key suppliers to increase value for Novartis. The Global Head Procurement REFS is the primary procurement business partner for Real Estate facility Services global organization, ensuring budget-alignment, strategy, and productivity achievement, including design and delivery of margin expansion initiatives across Novartis. The purpose of the role is to develop and maintain all organizational structures and necessary internal alignments to ensure an effective procurement process and provide high-value external solutions to the business supporting projects. The role is also responsible for the global category management of Real Estate, Facility Management, Development Construction management, etc This includes the overall governance and management of special projects across Novartis About the Role Major Accountabilities: Demand management Implement for key sourcing category plans to source fit for purpose demand from suppliers with optimal unit cost for materials / services (competitive bidding, majority of spend with new disruptive suppliers). Work on Intake Solutions and Demand Management to enable active demand management in all categories and strengthen unit cost KPIs. Analyzing specifications for optimization. Linking specification to customer value, challenging specification confidently. Conveying messages clearly and convincing stakeholders. Sourcing and supplier relationship management Executing the Source-to-Contract process including respective strategies, approaches and methods: preparing and conducting fact-based negotiations. Adapting tactics from a broad portfolio of negotiation strategies to achieve results that support business and Procurement Keep supplier base stable while focus on Supplier Diversification to foster the usage of acceptable suppliers within the updated preferred vendor concept as part of the new Global Procurement Guideline Drive and implement sustainable price/improvement initiatives Accountable for productivity/cost efficiency targets. Accountable for key compliance metrics such as PO-compliance, process compliance, internal audits. Support centrally led processes (eg, NFCM, TPRM). Successful implementation of global, regional and country projects across categories functions, ensure key stakeholder alignment and customer satisfaction. Manage quality of the REFS end-to-end Procurement process incl. compliance to policies, sourcing strategies and processes. Introduce new disruptive vendors to exchange existing ones with same quality but cheaper prices Manage relationships with senior stakeholders Serve as the key contact for senior stakeholders in the organization for all Procurement-related topics. Build effective relationships of mutual trust and understanding. Achieving results by proactively building long-term, sustainable and effective relationships, understanding the stakeholder landscape and demonstrating political astuteness across business structures and networks Manage Global/Regional/Country/NOCC Procurement team Lead the Country Procurement team and act as a role model of the Novartis Values Behaviours. Lead Procurement REFS model in the areas of responsibility. Regularly assess develop the team s capabilities (hard soft skills). Identify and develop key talents in the organisation through assignments, (above)-country projects, mentoring coaching. Minimum Requirements: >10 years of relevant business experience (industry specific experience). Preferably > 10 years of experience in Procurement or other related experience within the pharmaceutical industry, preferably in category management, supplier management, or related area, with a focus in with a focus in the Procurement domain. Strong project management or other leadership experience. University/Advanced degree needed. masters Degree/other advanced degree is preferred. Excellent spoken and written English. Other foreign languages as required.

Digital Finance, Manager (Analytics Operations)

Hyderabad

5 - 10 years

INR 20.0 - 25.0 Lacs P.A.

Work from Office

Full Time

Summary About the role: You would be an integral part of the Digital Finance team based in Hyderabad, as part of the larger Corporate BPA function shaping our financial landscape. The Business Operations team supports the Novartis vision through ensuring robustness and availability of cutting edge analytics and reporting digital solutions designed for the Finance ecosystem including CXOs, BPAs and data analysts. You will work with end users, finance leaders and product managers to deliver high impact business solutions and drive operational excellence. As a Senior Operation expert, you'll drive a state-of-the-art digital finance applications adoption amongst finance and non-finance users. You would act as the trusted business partner for our users, ranging from finance leaders to country end-users including providing First level support for user queries. This role provides a platform to drive operational excellence initiatives to further empower our community with real-time analytics. About the Role Key Requirements: Acting as first level support for our users across the globe, delivering best-in-class solutions and ensuring business continuance in our various platforms. Cross functional collaboration. Ability to translate business challenges and addressing them with our IT partners (acting as a bridge between stakeholders and IT team) Ability to work with technical team to ensure daily operations continuity Handle multiple processes and activities in parallel (experience with UAM is plus) Drive process excellence initiatives ensuring our recurring process are optimal, while keeping a user-centric mindset. Identify the scope of process improvements, automations to facilitate efficient operations. Interact each day with various business stakeholders; so, having clear and effective communication is the key. Work closely with product managers to facilitate new solutions, features by supporting data analysis, setting up standard processes and documentation. Essential Requirements: Excellent communication skills, experience to communicate with business leaders through all level of organization. Experience of working on business system analysis, process automations; data simplification using advance tools. Ability to manage multiple tasks, deadlines and adapting to continuous system changes. Desirable Requirements: 5+ Years of experience in business operations, skills and/or practical experience on basic Finance data analytics. masters/bachelors degree in business management, Finance or FinTech related field.

Territory Business Executive

Hyderabad

4 - 9 years

INR 6.0 - 11.0 Lacs P.A.

Work from Office

Full Time

-The Sales Representative is a leading driver of our customer interactions and sales performance. They are the face of our customer experience approach and build deep relationships that deliver value for customers and patients in order to drive sales growth in a compliant and ethical manner Major accountabilities: Drive Competitive Sales Growth -Identify and prioritize high-potential customers through data analysis (HCPs and stakeholders) who influence prescription decisions -Drive sales performance through the skillful orchestration of positive customer experiences -Engage and Build Relationships -Engage in value-based conversations (in-person and virtually) to understand critical customer challenges, decision-drivers, pain points and opportunities -Personalize and orchestrate customer engagement journeys for target HCPs by reflecting customer preferences, leveraging available content and multiple engagement channels -Build engagement by working in partnership with HCPs to develop a sustained collaboration over time for Novartis -Deliver memorable, customer-centric experiences beyond clinical differentiation by listening to their needs and understanding their healthcare environment -Establish effective working relationships with opinion leaders and top medical influencers (at territory level) and challenge current behaviors in order to improve the patient journey (right patient, right time) -Develop Deep Customer Insights and Understanding -Gather insights on the customer s business to uncover what is important to them -Follow up on customer feedback and translate responses into actions that create additional value and exceed expectations -Leverage available data sources to create, dynamically prioritize and adjust relevant territory, account and customer interaction plans -Share customer insights with relevant internal stakeholders on an ongoing basis to support the development of product-and indication-related content, campaigns and interaction plans -Deliver Value to Customers and Patients -Collaborate compliantly with cross-functional teams to design and implement solutions that address unmet customer and patient needs -Act as a trusted partner to the customer for the purpose of helping them run their business; listen to learn; strive to deepen the relationship in a compliant and ethical manner; position themselves to create value-add solutions . Act with integrity and honesty by treating customers and colleagues in a transparent and respectful manner with clear intent. When facing ethical dilemmas, do the right thing and speak up when things dont seem right. Live by Novartis Code of Ethics and Values and Behaviors. Key performance indicators: To be populated at local level, based on the guidance that will follow from IMI Field Engagement Performance Management Council outcomes. Minimum Requirements: Work Experience: Established Network to target Customer Group desirable. Sales in Healthcare / Pharma / related business. Skills: Account Management. Commercial Excellence. Communication Skills. Compliance. Conflict Management. Cross-Functional Coordination. Customer Insights. Ethics. Healthcare Sector. Influencing Skills. Negotiation Skills. Selling Skills. Technical Skills. Languages : English.

Business Data Migration Expert-Sales Management

Hyderabad

5 - 10 years

INR 12.0 - 17.0 Lacs P.A.

Work from Office

Full Time

Summary Business Data Migration expert for Order to Cash on LDC ERP program ensures data is delivered according to global/deployment/country requirements and timelines and responsible for data migration activities in a deployment (above-country) for Data objects in his/her scope. The data includes but is not limited to Customer master, Product Pricing, Contracts. Acts as the functional SPoC for data migration on the assigned objects for a given release. Job Purpose Business Data Migration expert for Order to Cash on LDC ERP program ensures data is delivered according to global/deployment/country requirements and timelines and responsible for data migration activities in a deployment (above-country) for Data objects in his/her scope. The data includes but is not limited to Customer master, Product Pricing, Contracts. Acts as the functional SPoC for data migration on the assigned objects for a given release. Major Accountabilities Perform or ensure data cleansing tasks are completed on time Complete data collection for manual/construction objects on time Work together with IT counterparts to prepare value mappings Create and maintain master lists if applicable for assigned objects Provide business insights and information to technical teams for extraction and conversion from the legacy system(s) for assigned data objects Work together with IT team and country Business Data Owners to identify objects in scope for country Ensure data readiness verify quality throughout data journey for assigned data objects Verify that data is fit for purpose (incl. alignment with internal/external stakeholders) Approve upload files before and after load for all assigned data objects (including formal approval) Perform manual (type-in) data loads into target clients where applicable for assigned objects Perform dual maintenance Execution and approval of data verification scripts Act as SPoC for assigned objects as part of defect management process during Hypercare Key Performance Indicators / Measures Of Success Data Cleansing completion for relevant data objects on project(s) within the region based on given data migration schedule Data Loads completion for relevant data objects on project(s) within the region based on given data migration schedule All major issues related to data quality for relevant data objects resolved based on given project(s) schedule IDEAL BACKGROUND Education Qualifications Bachelor or Master degree preferred Languages Fluent English (additional languages preferred) Experiences 5+ years in country global roles (ERP project implementation experience preferred) Competencies Good communication and negotiation skills, good stakeholder management Strategic and hands on way of working (running meetings, tracking progress, managing issues) Strong Excel Skills Technical/Functional Skills Knowledge Strong knowledge about the business processes in the area of Order to Cash, Contract management, Order to Cash, Pricing and good visibility to Customer master and sales view of Material master data Data Migration experience preferred

Director - Gen AI Applications

Hyderabad

15 - 20 years

INR 50.0 - 55.0 Lacs P.A.

Work from Office

Full Time

Summary Location: Hyderabad As the Hands-On Architect for the Novartis Generative AI platform, you will be the cornerstone of technical strategy and innovation at Novartis. Your deep industry knowledge and technical expertise will drive the development of architectures that support scalable, secure, and efficient GenAI applications across the enterprise. About the Role Major accountabilities Define and refine architectural frameworks for the Novartis Generative AI platform. Lead strategic technology initiatives, aligning them with business objectives and regulatory standards. Collaborate with business and IT stakeholders to translate business needs into technical strategies. Oversee the design and implementation of enterprise-wide systems and infrastructures. Mentor and provide technical leadership to development teams. Define and execute technology delivery strategy for business systems, platforms, and processes for business domain/function(s) in scope. Partner with senior business stakeholders and TT Strategic Business Partners for demand analysis, solution proposal/evaluation, and funding estimates. Partner with relevant Technology Service/Solutions Delivery teams to ensure that the product and platform strategy balances the sophisticated needs of Key Markets, need for reuse across other priority markets and cost, while effectively scale at speed to remaining midsize/small markets. Ensure on time, within budget, compliant, secure, and quality delivery of portfolio. Define and evolve SI Partner Strategy and effectively manage and govern engagements to jointly deliver business value. Pro-actively engage with Technology and Platform partner to jointly strive for innovation and engage in Design Partnerships. Ensure services, solutions, platforms, products are fit for purpose and achieve the desired business value and impact. Run efficient DevSecOps for platforms, products, or systems ensuring availability and optimal performance. Establish governance structure for projects, operations, etc with right stakeholder representation. Ensure enterprise grade and state of the art Solution Design and Architecture with maximizing re-usability, configurability and scalability. Track, report, and deliver against agreed success factors and KPIs for various stakeholders in TT and business. Follow industry trends and emerging practices to drive agility, speed, efficiency, and effectiveness. Ensure the overall user experience is taken into account when designing deploying new solutions and services. Ensure adherence to Security and Compliance policies and procedures as we'll as with other Novartis guidelines and standards. Minimum Requirements: Advanced degree in Computer Science, Software Engineering, or related field. Over 20 years of experience in software architecture and development. Profound knowledge of Python, NodeJS, AWS, Azure, and full-stack technologies. Proven ability to architect enterprise-scale solutions. Exceptional leadership, communication, and analytical skills. Launch of innovative technology solutions across Novartis at scale. Business impact and value generated from TT solutions. Adoption and development of Agile, Productization and DevSecOps practices. Operations stability and effective risk management

Associate Analyst - Master Data Management

Hyderabad

2 - 4 years

INR 6.0 - 10.0 Lacs P.A.

Work from Office

Full Time

-Responsible as a specialist for warehouse logistics whilst meeting Pharmaceutical Regulatory and Corporate Guidelines. About the Role: Responsible for the site Master Data processes aimed to ensure accurate and timely creation and maintenance of the master data in the ERP System, in accordance with local and global requirements. -The Material Planner drives the tactical purchasing process for all materials to ensure materials availability and execution plan feasibility in accordance with Site inventory policy. Key Responsibilities: Master Data -Set up and perform complex local And global master data set up And establish process, guidelines, business matrix and SLA time lines in in GxP environment in adherence to Novartis compliance. Be SME in the assigned area of work -Support data collection and reporting of important metrics -Logistic, WAndD -Responsible that all logistic processes are proceed in a timely, high quality, efficient and effective manner and in full compliance with all laws and supply chain management policies and procedures. Identify and drive continuous improvement projects. Ensure material availability in line with the approved production plan. Ensure daily MRP oversight for all BOM material, analysis of requirements and Purchase Orders management. Ensure daily MRP oversight for all BOM material, analysis of requirements and Purchase Orders management. Own, in ERP System, MRP relevant data and materials technical specifications and ensure no Purchase Orders are past due in the ERP System. Management of purchased item Complaints/Returns to supplier. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) -Provide expertise and system support for returns, rebates and credit/debit notes -Define and decide on priorities for physical deliveries in collaboration with other functions (eg LEX) for 3rd party customers and cross divisional supplies -Act as SPOC for partner concern issues for assigned customers -Influencing and connecting relevant partners to speed up (system) issue resolution -Material Planner -Ensure management of daily MRP exception messages And appropriate follow up. Provide a load balanced dispatch list for incoming materials to the warehouse and Quality department that ensures these activities are completed in line with the production needs. Essential Requirements: Collaborating across boundaries. Operations Management and Execution. Project Management. Inventory Management, Gap Analysis, Cost Efficiency and efficiency of supply processes -Standard Master Data KPIs eg Completeness, Consistency and Accuracy. Desirable Requirements: Bachelor / Masters Degree with experience in Pharmaceutical Industry/ specifically GMP background.

Business Data Migration Expert - Procurement

Kota, Jaipur, Bikaner, Jodhpur

5 - 10 years

INR 13.0 - 17.0 Lacs P.A.

Work from Office

Full Time

Summary Business Data Migration expert for Procurement (Direct and Indirect) on LDC ERP program ensures data is delivered according to global/deployment/country requirements and timelines and responsible for data migration activities in a deployment (above-country) for Data objects in his/her scope. The data includes but is not limited to Vendor master, PO, PR, SL, PIR in both Direct and Indirect Procurement. Acts as the functional SPoC for data migration on the assigned objects for a given release. About the Role Location - Hyderabad Key Responsibilities: Perform or ensure data cleansing tasks are completed on time Complete data collection for manual/construction objects on time Work together with IT counterparts to prepare value mappings Create and maintain master lists if applicable for assigned objects Provide business insights and information to technical teams for extraction and conversion from the legacy system(s) for assigned data objects Work together with IT team and country Business Data Owners to identify objects in scope for country Ensure data readiness verify quality throughout data journey for assigned data objects Verify that data is fit for purpose (incl. alignment with internal/external stakeholders) Approve upload files before and after load for all assigned data objects (including formal approval) Perform manual (type-in) data loads into target clients where applicable for assigned objects Perform dual maintenance Execution and approval of data verification scripts Act as SPoC for assigned objects as part of defect management process during Hypercare Commitment to Diversity Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Desirable Requirements: Data Cleansing completion for relevant data objects on project(s) within the region based on given data migration schedule Data Loads completion for relevant data objects on project(s) within the region based on given data migration schedule All major issues related to data quality for relevant data objects resolved based on given project(s) schedule Education Qualifications Bachelor or Master degree preferred Languages Fluent English (additional languages preferred) Experiences 5+ years in country global roles (ERP project implementation experience preferred) Competencies Good communication and negotiation skills, good stakeholder management Strategic and hands on way of working (running meetings, tracking progress, managing issues) Strong Excel Skills Technical/Functional Skills Knowledge Strong knowledge about the Direct and Indirect Procurement business processes in the area of Material management, Vendor master, Supplier Contracts, PO lifecycle. Data Migration experience preferred

Marketing_Marketing Servcies

Hyderabad

8 - 13 years

INR 9.0 - 13.0 Lacs P.A.

Work from Office

Full Time

Summary Located in Hyderabad and part of the Insights and Analytics, International business, this role provides comprehensive guidance and operational support in relation to insights and analytics for a designated product or group of products within a particular disease area. The Senior Integrated Insights Manager (Sr IIM) is the go-to contact for the international brand teams and their nominated Single Point of Contact (SPOC), playing a crucial role in supporting Int l TAs and Customer market activation function, top markets and regions. About the Role Partner with teams as mentioned above to provide strategic insights that shape/develop program/brand strategy Drive comprehensive outside-in strategic perspective bringing value adding insights on patients, customers, competitors, payers and regulators Analyzing and evaluating information from research, intelligence and analytics, making connections between the information found, and combining the recently acquired information with prior knowledge to create new insights that enable fact-based decision making Comfortable in interpreting market data - including Patient analytics, Physician analytics, Customer engagement - to make business recommendations and actions. Design and plan all facets (key Business and intelligence Questions) to enable execution of market research, competitive intelligence and analytics based on a sound understanding of the research tools, techniques and datasets Develop insight storylines and narratives that guide strategic decisions and optimizes market activation Proactively Investigate solve for strategic business challenges Ideal Background: Education: Graduate / Postgraduate in Engineering / Pharmacy / Medicine / Science / Statistics / Business or related fields (including MBBS/MDs/MS/MPH) Languages: Superior verbal and written communication skills mandatory. English proficiency is essential. Experience/Skills: A sound understanding of the Therapeutic Disease Area, disease state and product expertise including market dynamics and commercialization strategies. 8+ years of pertinent experience in pharmaceutical companies and/or strategic, marketing, or healthcare consultancy companies and preferably experience in two areas of either Market Research/Analytics role with a leading pharmaceutical or Fast-Moving Consumer Goods (FMCG) company/solution provider. Superior analytical skills, with proven experience in using tools such as Excel for analyzing and visualizing data. Must be comfortable transforming data into visually understandable formats using standard tools/charting methods. Demonstrated proficiency in storyboarding and applying behavioral science with human insights. Proven expertise in project management, and in facilitating, cross-functional teams within a matrix environment. Values and Behaviors: Ability to thrive in ambiguous, fast-paced environments that are led by leadership requests and the evolving needs of the franchise. Capability to manage workload with limited supervision and support in prioritization; effectively managing expectations and able to independently scope/prioritize work. Demonstrates accountability, initiates action, takes responsibility for execution, and voices opinions when appropriate. Advocates for open communication, constructively addresses issues or lets them go. Operates with mutual respect, integrity, and embraces diversity, collaboration, and candor.

Associate Director, ERC Data Analytics and Insights

Hyderabad

15 - 20 years

INR 30.0 - 35.0 Lacs P.A.

Work from Office

Full Time

The Associate Director in the Corporate ERC Data Analytics and Insights team will partner with ERC process owners and colleagues across countries to enhance operational oversight and strategic decision-making through data and insights. The role involves formulating an integrated analytical approach from data discovery, building data pipelines, connecting databases, and uncovering actionable insights through both descriptive and advanced analytics, including statistical analysis, AI, machine learning models, and GenAI solutions. About the Role Major Accountabilities: Collaborate with process owners and ERC analytical product users to understand their complex and critical compliance priorities, enabling them through data and actionable insights. Work with team members such as data engineers, data scientists, business analysts, UX designers, and developers to create actionable insights published on insights products like Control Room and Control Tower for various ERC personas. Conceptualize, design, and develop data science projects and proof of concepts on prioritized ERC use cases. Drive data-driven innovation and support operational excellence through simplification and automation initiatives. Promote a data-driven decision-making culture through coaching, mentoring, and introducing industry best practices and external perspectives. Essential Requirements: Masters or bachelors degree in Data Analytics, Data Science, Business, or Engineering is required; an MBA from a reputed institute is preferred. 15+ years of experience in Data Analytics or related fields, with specific experience in producing insights for senior management and building statistical models to address business issues. Experience in Risk or Compliance Analytics in the Pharma or Life Sciences industry is preferred. Demonstrated experience in designing and delivering insights using AWS, Snowflake, Databricks, and Python libraries for industrialized analytics solutions leveraging statistical models, AI/ML, including GenAI. Proven experience with web analytics tools such as Google Analytics on user insights to identify improvement opportunities. Ability to work with a multi-functional and multi-national team in a matrix environment. Identify trends, patterns, and anomalies leveraging data to inform strategic decisions and optimize user experience. Strong analytical skills with the ability to interpret complex data and generate actionable insights. Proficiency in data visualization tools (eg, Power BI, Web-mashup). Excellent communication skills with the ability to present data insights to non-technical stakeholders. 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.

Solution Architect (M365)

Jamnagar, Ahmedabad, Rajkot, Surat, Vadodara

18 - 20 years

INR 35.0 - 40.0 Lacs P.A.

Work from Office

Full Time

The M365 Solution Architect is a critical leadership role responsible for designing, implementing, and managing Microsoft 365 solutions that align with organizational business objectives. This position necessitates an in-depth understanding of Microsoft 365 architecture, encompassing Office 365, SharePoint Online, SharePoint Embed, MS Team, MS VIVA, Azure, Windows 11, and Enterprise Mobility + Security. About the Role Major accountabilities: Design and Implementation: Develop and implement M365 solutions that meet business goals and objectives. Functional Expertise: Deep expertise in the following areas is desired. ie, Content Management, Workplace Productivity, Employee experience, Collaboration tool kits. Technical Leadership: Provide technical direction and leadership for the M365 platform, guiding teams through complex implementations and migrations. Stakeholder Engagement: Collaborate with business stakeholders to understand requirements and translate them into effective M365 solutions. Security, Compliance and Governance: Ensure M365 solutions are secure and complaint with industry regulations and standards. Define and drive the governance for M365 solutions and Pharma domain specific ISRM and Appsec compliance. Performance Optimization: Monitor, tune and optimize the performance of M365 solutions, ensuring all non-functional requirements are met (Performance, Usability, Reliability, Security, Maintainability, availability). Innovation: Stay updated with the latest M365 features and capabilities, continuously improving solutions to leverage new functionalities. Identifying and implement innovation / automation / digitalize opportunities for the business requirements to simplify the solutions. Best practices: define and drive the best practices to be followe'd and implemented in all M365 solutions. Minimum Requirements: Overall 18+ Years of experience in IT solution design and delivery. Experience with M365: 10+ years proven experience in architecting M365 solutions in large enterprise environments. Cloud Computing: 10+ Years of experience with cloud computing technologies, including Azure and other Microsoft cloud services. Security and Compliance: Experience in ensuring security and compliance in M365 implementations, including knowledge of industry standards and regulations. Migration Projects: Experience in leading M365 migration projects for MA, including email, SharePoint, and OneDrive migrations. Technical Expertise: Comprehensive knowledge of Microsoft 365 architecture, including Office 365, Windows 10 11, and Enterprise Mobility + Security. Power Platform and Microsoft Co-pilot knowledge would be additional advantages. Project Management: Strong project management skills, capable of leading complex projects from conception to completion. Ability to drive the vendor partners. Communication Skills: Excellent verbal and written communication skills, with the ability to convey complex technical concepts to non-technical stakeholders effectively. Problem-Solving: Strong analytical and problem-solving skills, with the ability to troubleshoot and resolve complex technical issues. Collaboration: Ability to work collaboratively with cross-functional teams and build strong relationships with stakeholders. Certifications: TOGAF, IASA for architecture, Relevant Microsoft certifications, in M365 and Azure are highly desirable

Technical Product Lead

Mumbai

10 - 15 years

INR 15.0 - 20.0 Lacs P.A.

Work from Office

Full Time

Data42 is hiring a Technical Product Manager to lead the design, development, and delivery of its Data Analytics products, requiring a strong understanding of various data technologies and analytics tools. Excellent leadership, communication, and project management skills are needed, along with the ability to strategically interact with multiple teams across the company Job Description: Data42 is seeking a dynamic Technical Product Manager to spearhead the efficient design, development, and delivery of our Data Analytics products. The individual should illustrate superior leadership, communication, and project management skills. It is essential to have expertise in catalyzing product strategies, backed by a robust knowledge of diverse data technologies and analytics tools. Interaction across various functional and development teams across the company is crucial to this role. Responsibilities: 1. Strategize, develop, and implement the product roadmap aligned with market insights, customer needs, and business objectives. 2. Partner closely with the data42 Technology lead to manage the Product Portfolio Council" 3. Lead product roadmap development and execution for the Data42, aligning with company goals and strategy. Evaluate and incorporate appropriate technology solutions to meet business and product goals. 4. Analyze user feedback, market trends, and business indicators to define product enhancements or novel features. 5. Establish effective communication channels with stakeholders ensuring alignment in product development and delivery. 6. Lead cross-functional teams to ensure product initiatives are conceived, monitored, and delivered as per agreed timelines. 9. Foster innovation by keeping updated with contemporary trends, tools, and technologies in data analysis and product management. 10. Ensure data security and compliance with best practices, privacy laws, and regulations. 11. Mentor and guide junior staff to promote a highly productive, engaging, and inclusive work environment. Qualifications: 1. bachelors degree in computer science, Engineering, or a related field. 2. 10+ years of experience in managing technical products with strong technical background; 3. Demonstrable experience as a Technical Product Manager, or comparable role, within a data focused company. Strong experience in project management, preferably with Agile methodologies. 4. Excellent leadership, team management, and communication skills. 5. Strong decision-making skills with a demonstrated ability to drive product strategy based on competitive analysis, market, and product research. 6. Ability to communicate effectively with teams and clients. 7. 8. Great organizational and time-management skills with the ability to multitask. 9. Ability to stay current with technological developments and advancements in the field of data and analytics.

Assoc. Director - Mulesoft Lead

Hyderabad

9 - 14 years

INR 30.0 - 37.5 Lacs P.A.

Work from Office

Full Time

This is an exciting opportunity for you to shape how digital services are designed and delivered in a high impact environment, helping us to reimagine medicine! About the Role Major accountabilities: Ensure adherence to Security and Compliance policies and procedures. Lead MuleSoft development teams in designing and implementing scalable, high-performance Mulesoft integration solutions. Provide technical mentorship to junior developers, ensuring adherence to coding standards and fostering continuous learning. Collaborating with cross-functional teams to gather requirements and implement integration solutions. Ensuring the security, scalability, and performance of Mulesoft applications. Developing Mulesoft integration applications using Anypoint Studio. Creating API specifications and implementing API designs. Translate complete and accurate requirements into detailed technical designs, develop and unit test robust integration services. Collaborating with stakeholders to understand integration requirements. Conduct peer reviews of developed solutions and maintain formal documentation, promoting code review processes and knowledge sharing Take accountability for the quality of the software build ensuring alignment with both security and compliance policies and procedures. Utilize DevOps practices to support deployment of your software into project environments. Minimum Requirements: Proven experience in Mulesoft development and integration projects. Strong knowledge of Mulesoft Anypoint Platform and API management. Understanding of RESTful APIs, JSON, and XML. Expertise working with Mulesoft Cloudhub and RTF, persistence gateway, API Manager Familiarity with OAuth and JWT authentication mechanism Familiarity with DevOps practices and CI/CD pipelines, ensuring smooth and efficient software delivery and deployment. Has working experience with Salesforce/AWS connectors. Familiarity with Agile development methodologies, promoting collaboration, adaptability, and continuous improvement. Commitment to best practices, code quality, and maintainability, ensuring the long-term success of the software applications. Proactive attitude and ability to work independently, with excellent problem-solving skills and attention to detail. Excellent communication and interpersonal skills, enabling effective collaboration and teamwork. bachelors or masters degree in computer science or a related field is preferred, demonstrating a strong academic foundation in software engineering principles. Mulesoft developer certification is a must .

Specialist - Quality Operations

Hyderabad

6 - 11 years

INR 7.0 - 8.0 Lacs P.A.

Work from Office

Full Time

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. About the Role: This position is responsible for quality oversight of contract manufacturers for drug product/drug substance/intermediate product/raw material of ADACAP. Key Responsibilities: Develops and maintains a Quality Assurance Agreement in cooperation with the external partners. Responsible for the initial qualification and onboarding of contract manufacturers as we'll as for performing regular quality risk assessments. Ensures that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable ADACAP and Novartis standards, the effective Quality Assurance Agreement, relevant guidelines and the Quality Management System of the external partners. Manages and oversees contract manufacturer s activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc according to the Quality Assurance Agreement and the Novartis Quality Manual. Ensures investigations are appropriately executed within agreed timelines, including documentation and effective measures to prevent recurrence. Support the Novartis audit of contract manufacturers and act as QARP and or FURP as required. Ensures that change requests, either from contract manufacturer or from ADACAP, are managed according to the Quality Agreement and ADACAP change control procedures from receipt, through to the implementation and closure. Reviews third party documents from a quality point of view (ie product test methods, specifications, and protocols/reports for activities such as stability, analytical method transfer, manufacturing process transfer, product comparability, process characterization, process validation, etc). Performs, coordinates or archives GMP documentation as defined by the Quality Agreement and ADACAP SOPs. Responsible for compiling product quality reviews in cooperation with external partners. Initiates and drives quality improvement projects as required. Supports the quality function on general topics as assigned. Writes and maintains general concept descriptions of the assigned topics and presents the assigned topic in audit situations. Develops related procedures or provides input as needed. Escalates significant quality incidents and supply risks as per ADACAP and Novartis escalation policies to management. Responsible for reporting and trending of defined key performance indicators per assigned contract manufacturers. Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers. Commitment to Diversity Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Commitment to Diversity Inclusion: : Essential Requirements: At least 6 years of experience in pharmaceutical quality assurance, quality control or manufacturing At least 3 years of experience in a Quality Assurance function Thorough knowledge of cGMP requirements and their practical application in routine biological manufacturing Proven track record of maintaining quality oversight on external partners Experience with biological manufacturing would be an additional asset Good communication skills Team and consensus builder, with definitive and authoritative decision making ability. Desirable Requirements: Higher university degree (Masters, PhD or equivalent) in Pharmaceutical, Chemistry, Biochemistry, or another related science Languages: Fluent in speaking and writing in English

Senior GCP/PV Auditor

Hyderabad

7 - 12 years

INR 10.0 - 14.0 Lacs P.A.

Work from Office

Full Time

Lead, support and report independent GCP/PV audits according to the NVS Quality Sys-tem and the current GCP/PV regulations to assess compliance with applicable regula-tions, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. Ensure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to NVS business units through risk based assessments. Act as SME for assigned areas of responsibility. Key Responsibilities: Support the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan. Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as we'll as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence. Provide technical guidance, leadership, mentoring and training of other auditors on audit related activities.Prepare audit reports according to NVS requirements and timelines. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).. Identify and communicate quality and regulatory compliance issues to Quality Management through appropriate channels as we'll as recommend remediation. Lead compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement as requested. Support Mock Pre-Approval Inspections (PAIs) and Health Authority (HA) inspections as needed. Proactively research local and global initiatives, trends and events that impact maintenance of compliance.Complete any other requests from Global GxP Audit. Review and approve audit reports as required. Commitment to Diversity Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Essential Requirements: 7+ years of GCP/PV/Pharmaceutical. Industry/Health Authority experience or equivalent. 3 years of GCP/PV auditing experience; 5 years preferred; experienced in both GCP and PV auditing is ideal. Willingness to travel approximately 60% of the time. Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision. Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving. Experience with Health Authority inspections and interaction. Excellent quality and compliance leadership and facilitation skills. Excellent verbal and written communication, organizational and interpersonal skills. Desirable Requirements: Good knowledge of computer systems validation and 21CFR Part 11 requirements. Ability to lead audit teams and operate successfully in various team capacities.

Director Enterprise Architect, Development- TRD

Hyderabad

10 - 15 years

INR 50.0 - 55.0 Lacs P.A.

Work from Office

Full Time

Summary This role is to provide operational and technical management for the TRD Architecture team and become the trusted partner for our Business, business facing teams and IT leads to provide best in class services to our organization. This is a key role to continue to shape the future of our IT landscape and to support strategic business goals. The purpose of the role is to drive technology standards definition in close collaboration with Enterprise Architects by bringing teams together and driving the design of the best solution to meet the business needs and deliver business outcomes. Handle the development of architectural standards, and the direction and design of architecture for a business or technical domain. About the Role Key Responsibilities: Oversee architectural activities for Technical Research and Development (TRD) and handle the development of solution architectures for projects or programs within TRD. Coordinate with other teams to ensure right business and technical capabilities are incorporated into the solution with appropriate scaling model for future increase in capacity Define standards and direction of architecture for TRD and ensure business processes, business requirements outcomes are defined to drive the architecture definition Define and develop the logical design and information management plans necessary to store, move and handle data in a new target state. Utilize architecture patterns to suggest the most adequate utilization of technical platforms in support of the holistic solution architecture design. Contribute and ensure adherence to Enterprise standards, Architecture Governance (eg architecture methods, tools, practices and standards) for DDIT, supporting the Architecture Governance team / Community of Practice Contribute to DDIT Level Architectural initiatives, including Architecture Simplification and Enterprise Level technology evaluations. Lead the integration of emerging technologies and innovative solutions into the TRD architecture to support digital transformation and business growth. Ensure overall user experience is taken into account when designing and deploying new solutions and services and adherence to ISC, Legal, ethics and other compliance policies and procedures in defining architecture standards, patterns, and solutions. Drive end2end overview and governance of standard solution portfolio for Technical Research and Development Domain and support business partners when discussing with the business topics related to technology architecture Essential Requirements Education Qualifications bachelors degree in computer or IT related field or technical discipline, MBA optional Experience 10 years experience working in an IT environment with experience working in Pharmaceutical industries, preferably in Drug Development/ Clinical space Advanced knowledge of Lean/ Six Sigma, Design Thinking, Agile methodology Extensive project management and change management experience Leveraging digital technology in Drug Development space Track record delivering global solutions at scale, and interactions with senior management Delivery of validated IT solutions and collaborating across boundaries Experience delivering and managing manufacturing IT system landscape in pharmaceutical industry. Experience in delivering and managing manufacturing IT system landscape of pharmaceutical industry Deliver data driven recommendations to improve efficiency and add value.

Business Data Migration Expert - Manufacturing

Hyderabad

5 - 10 years

INR 14.0 - 18.0 Lacs P.A.

Work from Office

Full Time

Business Data Migration expert for Manufacturing on LDC ERP program ensures data is delivered according to global/deployment/country requirements and timelines and responsible for data migration activities in a deployment (above-country) for Data objects in his/her scope. The data includes but is not limited to Material master, BOM s, Routings, Equipments and Task lists. Acts as the functional SPoC for data migration on the assigned objects for a given release. About the Role Job Purpose Business Data Migration expert for Manufacturing on LDC ERP program ensures data is delivered according to global/deployment/country requirements and timelines and responsible for data migration activities in a deployment (above-country) for Data objects in his/her scope. The data includes but is not limited to Material master, BOM s, Routings, Equipments and Task lists. Acts as the functional SPoC for data migration on the assigned objects for a given release. Major Accountabilities Perform or ensure data cleansing tasks are completed on time Complete data collection for manual/construction objects on time Work together with IT counterparts to prepare value mappings Create and maintain master lists if applicable for assigned objects Provide business insights and information to technical teams for extraction and conversion from the legacy system(s) for assigned data objects Work together with IT team and country Business Data Owners to identify objects in scope for country Ensure data readiness verify quality throughout data journey for assigned data objects Verify that data is fit for purpose (incl. alignment with internal/external stakeholders) Approve upload files before and after load for all assigned data objects (including formal approval) Perform manual (type-in) data loads into target clients where applicable for assigned objects Perform dual maintenance Execution and approval of data verification scripts Act as SPoC for assigned objects as part of defect management process during Hypercare Key Performance Indicators / Measures Of Success Data Cleansing completion for relevant data objects on project(s) within the region based on given data migration schedule Data Loads completion for relevant data objects on project(s) within the region based on given data migration schedule All major issues related to data quality for relevant data objects resolved based on given project(s) schedule IDEAL BACKGROUND Education Qualifications Bachelor or Master degree preferred Languages Fluent English (additional languages preferred) Experiences 5+ years in country global roles (ERP project implementation experience preferred) Competencies Good communication and negotiation skills, good stakeholder management Strategic and hands on way of working (running meetings, tracking progress, managing issues) Strong Excel Skills Technical/Functional Skills Knowledge Strong knowledge about the business processes in the area of Manufacturing: Production planning, Supply chain, Plant maintenance Data Migration experience preferred

Manager, Labor Rights

Mumbai, Nagpur, Thane, Nashik, Pune, Aurangabad

6 - 11 years

INR 25.0 - 30.0 Lacs P.A.

Work from Office

Full Time

We are seeking a confident, collaborative, and solutions focused Manager, Labor Rights to support the execution of Novartis global labor rights program, with a focus on India and the broader Asia Pacific Middle East and Africa (APMA) region. This role will support labor rights and raw material certification risk assessments due diligence for external partners; drive mitigation efforts and contribute to the development of the Labor Rights (LR 2.0) program. The role will also support in meeting our corporate responsibility under Corporate Sustainability Due Diligence Directive (CSDDD), particularly focused on supply chain risks beyond primary Tier 1 partners. This is an execution-focused position, requiring strong project management, stakeholder engagement, and hands-on experience in operationalizing labor rights standards in Novartis value chain. About the Role Key Responsibilities Lead risk assessments due diligence on labor rights and raw material certification for all in-scope external partners, including creating, tracking and closing mitigation actions/corrective action plans (CAPAs), in line with Novartis global labor rights risk management protocols and international human rights standards. Deliver capability-building programs for external partners using a maturity model framework. Provide targeted training and guidance to internal stakeholders viz. Procurement, Business Owners, Legal and other relevant functions to embed labor rights due diligence into business processes. Support the deployment of risk tools (eg, worker voice, grievance mechanisms) to enhance labor rights risk assessments remediation. Investigate and resolve relevant SpeakUp cases related to external partners. Track and report relevant program KPIs and maintain labor rights data for reporting and continuous improvement. Support implementation of labor rights-related projects and activities identified through CSDDD gap analysis, especially in the APMA region. Contribute to relevant CSDDD workstreams especially Assessments, Risk Mitigation, Remedy, and Stakeholder Engagement. Actively support the broader Human Rights team strategy and cross-functional projects. Qualifications Experience Degree or equivalent experience in law, human rights, supply chain management, international relations, international development, or related fields. Experience in labor rights risk management, including hands-on engagement with external partners on labor rights compliance with international labor standards. Familiarity with international labor standards (eg, ILO Core Conventions, UNGPs, OECD Guidelines) and CSDDD. Strong analytical skills to translate data into clear, actionable insights. Fluency in English; additional languages relevant to the APMA region are a plus. Key Attributes Strategic Analytical: Comfortable interpreting risk data and identifying trends to inform decisions. Collaborative: Builds strong partnerships across internal stakeholders and external partners. Agile and proactive : Responds quickly to evolving priorities, anticipates issues, and drives practical solutions. Effective Communicator: Clear, persuasive, and audience appropriate. Results-Oriented: Owns deliverables end-to-end and thrives in a fast-paced environment. Structured: Manages multiple workstreams with clarity and discipline. Commitment to a people-first, risk-based approach that prioritizes worker we'll-being

Specialist-Quality Operations

Hyderabad

1 - 6 years

INR 7.0 - 8.0 Lacs P.A.

Work from Office

Full Time

Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. About the Role: Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Common Accountabilities (Applicable to all service teams) Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc) to ensure appropriate execution of service deliverables Generate and analyse predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc) and perform follow-up actions if required Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes Assist the department on any other ad hoc administrative activities as per business requirements. Focus on timely completion of all relevant and assigned trainings Learn develop understanding to generate insights through data and digital Ensure responsibility and ownership of the assigned tasks Comply the accuracy and timeliness of deliverables Comply to the applicable Novartis operating procedures as per legal / IT / HR requirement Provide active support during internal and external audits by collecting and presenting the requested process data/reports Adhere to the current GxP and compliance policies of Novartis. Key performance indicators: Extract data from relevant sources in Novartis tools/ applications. Interpret and compile external supplier APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review. Collect contributory reports for product related evaluations. Interact with CMOs and / or manufacturing sites as required. Support in updating and maintenance of APQR schedule. Perform review of APQR report/ data as applicable to ensure it is complete and correct. Complete APQRs within defined timelines. Archive the approved APQR as applicable Update APQR data in e-compass file followe'd by interpretation of data to conclude product robustness. Marketing Authorization Holder (MAH) Review: Support in maintenance of MAH/BRS review schedule Coordinate with NCQ SPoCs and/ or manufacturing/ packaging/ testing/ batch releasing sites as required to draft MAH/BRS checklist Extract data from relevant sources as applicable and compile MAH/BRS as per the requirements in a predefined format Interpretation and consolidation of the data Review for accuracy and completeness of compiled data /information Submit the drafted MAH/BRS reviews for approval to respective Country quality team Archive the approved MAH/BRS review documents Education Background: M.Pharm/ MBA / Engineering/equivalent from a reputed institute. Min 1 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ Medical device. Basic awareness of GxP compliance requirements.

Associate Director Biostatistics

Mumbai

10 - 15 years

INR 45.0 - 50.0 Lacs P.A.

Work from Office

Full Time

Provide highly advanced expert support functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other RD areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and systems -Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams Key Responsibilities Study Level- Responsible for all statistical tasks on assigned clinical or non-clinical trials, and perform these tasks for high complexity trials with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, and reporting activities. Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and pricing reimbursement submission and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs and dose-finding strategies in alignment with the Lead Statistician. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, pricing agencies and other drug development activities, as required. Independently lead interactions with external review boards/ethics commit-tees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the clinical trial team and Biostatistics Pharmacometrics team. Independent oversight of all Biostatistics resources and deliverables for as-signed trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level- Responsible for strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, pricing reimbursement strategy, statistical deliverables). May be a core member of one or more early project teams representing Bio-statistics and Pharmacometrics. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful im-pact on robust drug development plans. Collaborate cross-functionally (eg, with data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables. Facilitate seamless transition of projects from early to late development. Effective partnership with other functions to ensure integrated quantitative in-put into project. Propose and implement innovative designs and methods to optimize drug development. Plan, prioritize and oversee project level statistical activities and ensure efficient resource management and effective partnership with vendors. Drive adherence to organizational standards and regulatory guidelines. Represent Biostatistics and Pharmacometrics at internal and external decision boards (eg regulators) Significantly contributes to project team preparation and may play a prominent role representing Biostatistics at HA meetings. Disease Area / TA/Indication level: As partner to clinical and scientific leadership, drive strategic statistical input and excellence to development programs within the assigned TA/DA/indications. Franchise or Global Line Function level: Lead or significantly contribute to initiatives at global line function level, or cross-functional Franchise level, requiring coordination of diverse of team members. May contribute to line function review. Enterprise level: Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Represent Biostatistics in due-diligence teams for low- to mid-complexity in-licensing opportunities with supervision. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewe'd journals, presentations and chairing sessions at professional meetings. External: Represent Biostatistics and Pharmacometrics in interactions with external re-view boards/ethics committees, external consultants and other external parties with increasing independence. Chair sessions at professional meetings. People Management: Develop and mentor statisticians. As a local manager, responsible to recruit, retain and professionally develop up to 8 biostatisticians. Role Requirements- MS (in Statistics or equivalent) with 10+ years relevant work experience or PhD (in Statistics or equivalent) with 6+ years relevant work experience Fluent English (oral and written) Strong interpersonal and communication skills bridging scientific and business needs. Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in use of statistical software packages (eg SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign. Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies. May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates. Good business ethics

QA Officer Operations

Mumbai

2 - 5 years

INR 6.0 - 10.0 Lacs P.A.

Work from Office

Full Time

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. Major accountabilities: Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person - Executes batch release in compliance with registration -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: On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration Minimum Requirements: Work Experience: Functional Breadth. QC/ QA in pharmaceutical ind./ biotech with environmental monitoring . Collaborating across boundaries. cleanliness zones. Skills: Continuous Learning. Dealing With Ambiguity. Gmp Procedures. Qa (Quality Assurance). Quality Control (Qc) Testing. Quality Standards. Self Awareness. Technological Expertise. Technological Intelligence. Languages : English.

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