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9.0 - 14.0 years
12 - 17 Lacs
Gurugram
Work from Office
Role & responsibilities Understand the project scope for QA, clarify the requirements prior to execution and deliver to execution plans. Develop and execute QA plans to meet the business objectives; adopt best practices and track KPIs/SLAs. Responsible for setting processes, documentation (Checklist) and quality assurance standards. Log defects against brand guidelines, themes, technical specifications, functionality verification with details, perform validation upon bug fix and track the defects towards closure. Communicate with the team and collaborate with other stakeholders on project requirements, deliverables, and challenges. Ensure compliance to defect tracking and management processe...
Posted 4 months ago
7.0 - 12.0 years
11 - 15 Lacs
Bengaluru
Work from Office
Novo Nordisk Global Business Services (GBS) India Department – Commercial, GBS Are you an expert in content insightsDo you have experience in Veeva Vault and Power BIWe are looking for a Project Manager-Content Insights to join our team in the Commercial, GBS department at Novo Nordisk. If you are ready for a new challenge, read on and apply today for a life-changing career. The position As a Project Manager for Content analysis, you will act as an expert within analytics of content usage across digital channels by interpreting data, report to the business on important KPIs and the content performance for global and local teams. Drive and develop the agenda of a data-driven approach in Novo ...
Posted 4 months ago
7.0 - 10.0 years
10 - 20 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Experience in doing external data reconciliation Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the cli...
Posted 4 months ago
2.0 - 5.0 years
4 - 7 Lacs
Hyderabad
Work from Office
What you will do We are seeking a detail-oriented and proactive Data Steward to support our pharmaceutical data governance initiatives. The ideal candidate will ensure the quality, consistency, integrity, and security of data across our systems, particularly within commercial, regulatory, R&D, and supply chain functions. You will play a key role in managing master data, supporting compliance (e.g., GxP, GDPR), and facilitating data-driven decision-making across the organization. Maintain and monitor master data for key domains (e.g., customer, product, vendor, material) Identify, investigate, and remediate data issues using profiling tools and dashboards. Define and enforce data definitions,...
Posted 4 months ago
5.0 - 10.0 years
30 - 35 Lacs
Noida
Work from Office
Position Summary This position is part of the technical leadership in data warehousing and Business Intelligence areas. Someone who can work on multiple project streams and clients for better business decision making especially in the area of Lifesciences/ Pharmaceutical domain. Job Responsibilities o Technology Leadership – Lead guide the team independently or with little support to design, implement deliver complex cloud data management and BI project assignments. o Technical portfolio – Expertise in a range of BI and data hosting technologies like the AWS stack (Redshift, EC2), Snowflake, Spark, Full Stack, Qlik, Tableau, Microstrategy o Project Management – Get accurate briefs from the C...
Posted 4 months ago
12.0 - 18.0 years
30 - 45 Lacs
Hyderabad, Bengaluru, Delhi / NCR
Hybrid
12+ years of IT Experience 4+ years in Veeva Vault in combination with any of below combined skills Must Have combinations of Specialized application expertise in or either (Atleast 3 combinations of any three below), Veeva CRM Suite, Veeva Vault RIM - Regulatory Information Management, Veeva Quality, Veeva LIMS - Lab information Management systems, Veeva Vault - Med Inquiry, Veeva Clinical Operations, Veeva Promo Mats Should have worked in Veeva LSH/ Health cloud environment for 3+ Years in Projects Able to demonstrate solutions/walkthrough with business stakeholders Should have hands on in Estimation / Presentation/Document preparation Veeva Vault Architecture experience Technical Expertis...
Posted 4 months ago
15.0 - 18.0 years
40 - 45 Lacs
Bengaluru
Work from Office
QUALIFICATIONS Education: Advanced degree in Life Sciences, Pharmacy, or related field Experience: 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals. Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred). Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees. Skills: Proficiency in clinical trial design, statistical analysis, and regulatory writing. Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms. Global Regulatory Strategy & Submissions Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan d...
Posted 4 months ago
4.0 - 7.0 years
7 - 15 Lacs
Thane, Pune, Bengaluru
Work from Office
Experience 4-8 Years of experience in specifications, design, develop and unit test and functionally validate clinical trial setup process edit check specifications and program or modify checks at study level within EDC SME (Subject Matter Expert) for all database related activities Familiar with custom functions within EDC system Prepare, test and implement postproduction changes as per study needs Work with leaders to resolve issues affecting the delivery of clinical trials Lead technology vendor oversight activities Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks
Posted 4 months ago
4.0 - 9.0 years
8 - 12 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
We are seeking a Clinical Programmer with expertise in JReview listings, dashboards, and visualizations to support clinical data review, safety monitoring, data validation and clinical data visualization, analysis, and reporting for clinical trials. Required Candidate profile 4+ Years of experience. MS SQL Server and R, R packages e.g., Tidyverse, ggplot2, dplyr, Pipeline creation, or Oracle, SAS, Python, Elluminate, BOXI, Spotfire, Tableau, Macros, RShiny, JReview, Plotly
Posted 4 months ago
5.0 - 10.0 years
4 - 7 Lacs
Chennai
Work from Office
5 years of experience working with Veeva CRM and Veeva Vault, including implementation, configuration, and support. In-depth knowledge of Veeva platform capabilities, including object configuration, workflow design, and data management. Strong analytical and problem-solving skills, with the ability to quickly diagnose and resolve technical issues. Excellent communication and interpersonal skills, with the ability to effectively collaborate with both technical and non-technical stakeholders. Experience working in regulated industries, such as pharmaceuticals or biotechnology, is preferred. Veeva certifications, such as Veeva CRM Administrator or Veeva Vault Administrator, are a plus. Familiar...
Posted 5 months ago
1.0 - 3.0 years
3 - 5 Lacs
Hyderabad
Work from Office
Sr Associate IS Analyst - Veeva Vault Release Engineer What you will do In this vital role in Amgen Veeva Release Management team and focuses primarily on change and release management, encompassing the planning, scheduling, and deployment of changes and releases across various Veeva Vault in Amgen. You will also provide essential support and expertise to key business users for smooth transition of the releases. Roles & Responsibilities: Support in development and implementation of the release management process for Amgen Veeva Vault platform. Manage release plans, including timelines, resources, and risk assessments. Collaborate with IT and business teams to facilitate smooth and efficient ...
Posted 5 months ago
4.0 - 9.0 years
6 - 11 Lacs
Hyderabad
Work from Office
Specialist IS Bus Sys Analyst Veeva Release Analyst What you will do In this vital role you will Amgens Veeva Release Management team, collaborating with business partners, product owners, developers, and testers to develop release strategies. Your role is crucial in ensuring compliance and successful transitions of Veeva releases. You will also provide essential support and expertise to key business users for smooth transition of the releases. Roles & Responsibilities: Support in development and implementation of the release management process for Amgen Veeva Vault platform. Handle release plans, including timelines, resources, and risk assessments. Collaborate with IT and business teams to...
Posted 5 months ago
5.0 - 10.0 years
0 - 0 Lacs
Navi Mumbai
Work from Office
Veeva Vault Quality Management System (QMS) Specialist Job Overview We are seeking a skilled Veeva Vault Quality Management System (QMS) Specialist, Aboobacker, to manage and optimize our Veeva Vault QMS platform. This role ensures seamless administration, configuration, and compliance of quality processes, collaborating with cross-functional teams to enhance operational efficiency and regulatory adherence in a life sciences environment. Key Responsibilities Serve as the primary administrator for Veeva Vault QMS, managing configuration, workflows, and triggers for quality processes such as audits, deviations, and supplier qualifications. Collaborate with business process owners to design and...
Posted 5 months ago
1.0 - 3.0 years
1 - 5 Lacs
Hyderabad
Work from Office
What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of Amgen’s Learning & Development Product Team, working closely with business collaborators, product owners, business analysts, developers, and testers to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the vendor, software development and configuration teams. This position is ideal for individuals looking for a career in systems analysis and software solutions, providing opportunities for professional growth and development in a dynamic, collaborative environment. Roles & Responsibilities: Collaborate w...
Posted 5 months ago
2.0 - 4.0 years
1 - 5 Lacs
Hyderabad
Work from Office
What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of Amgen’s Learning & Development Product Team, working closely with business collaborators, product owners, business analysts, developers, and testers to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the vendor, software development and configuration teams. This role will be pivotal in ensuring compliance, efficiency, and innovation in the administration of the learning management system (LMS) and related system architecture, including reporting and integrations. This role will support continuous impr...
Posted 5 months ago
2.0 - 5.0 years
9 - 12 Lacs
Hyderabad
Work from Office
Let’s do this. Let’s change the world. In this vital role you will iscover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. About the role Role Description: The Integrations Analyst is responsible for monitoring, updating and enhancing existing integration solutions using APIs (Application Programming Interfaces). The role involves connecting various systems, applications, and platforms through APIs to ensure smooth data exchange and interoperability between system...
Posted 5 months ago
2.0 - 6.0 years
7 - 10 Lacs
Hyderabad
Work from Office
Let’s do this. Let’s change the world. In this vital role you will discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. About the role Role Description: The Salesforce Analyst role is responsible for supporting, monitoring, maintaining and enhancing software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with the product team, the Salesfo...
Posted 5 months ago
4.0 - 6.0 years
6 - 8 Lacs
Hyderabad
Work from Office
What you will do Lets do this. Lets change the world. In this vital role you will play a critical role in shaping and delivering high-impact CRM solutions within the Salesforce and Veeva ecosystem. This position requires deep technical expertise in Salesforce and Veeva CRM along with a proven understanding of the pharmaceutical or life sciences industry. The ideal candidate will drive the design, development, and enhancement of scalable CRM solutions that align with evolving business goals and compliance standards. This role will also serve as a key technical resource across teams, for technical guidance, solution design and cross functional collaboration. Roles & Responsibilities: Design an...
Posted 5 months ago
3.0 - 7.0 years
11 - 14 Lacs
Hyderabad
Work from Office
Manager, CSAR - Global Library What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The positi...
Posted 5 months ago
5.0 - 10.0 years
9 - 13 Lacs
Hyderabad
Work from Office
Specialist IS Architect - Veeva Vault What you will do The role is responsible for developing and maintaining the overall data and IT architecture of Amgen’s Veeva Vault Platform . This role involves defining the architecture vision, creating roadmaps, and ensuring that IT strategies align with business goals, in Amgen’s R&D Veeva Vault Platform Agile Team. The role will be working closely with partners to understand requirements, develop architectural blueprints, and ensure that solutions are scalable, secure, and aligned with enterprise standards. The role will be involved in defining the Veeva Vault Platform Architecture strategy, guiding technology decisions, and ensuring that all implem...
Posted 5 months ago
6.0 - 8.0 years
8 - 11 Lacs
Hyderabad
Work from Office
The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management ...
Posted 5 months ago
1.0 - 4.0 years
4 - 7 Lacs
Hyderabad
Work from Office
The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process, while ensuring compliance with regulatory regulations and guidance. The ideal candidate will have a strong background in system analysis and data science/AI in a regulated industry. Roles & Responsibilities: Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements. Regulatory Busin...
Posted 5 months ago
5.0 - 8.0 years
7 - 10 Lacs
Hyderabad
Work from Office
What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site...
Posted 5 months ago
1.0 - 3.0 years
3 - 5 Lacs
Hyderabad
Work from Office
What you will do In this vital role you will join a collaborative team implementing and supporting the Integrated case management systems on existing & future technologies. In this role, you will wear several hats including requirement gathering, implementation and analyze and resolve issues with case intake and data transfer across integrated systems. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient processing of data. Roles & Responsibilities: Design & development activities and deploy applications to support GxP system Evaluate tasks for automation feasibility using RPA (UiPath), inte...
Posted 5 months ago
0.0 - 3.0 years
3 - 5 Lacs
Hyderabad
Work from Office
What you will do In this vital role you will we are seeking a highly skilled Associate IS Bus Sys Analyst to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. Roles & Responsibilities: Maintain existing code and configuration: Support and maintain SaaS applications Development &...
Posted 5 months ago
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