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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 3 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 3 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 3 months ago
5.0 - 8.0 years
4 - 7 Lacs
Chennai
Work from Office
Job Information Job Opening ID ZR_2214_JOB Date Opened 20/04/2024 Industry Technology Job Type Work Experience 5-8 years Job Title Veeva CRM City Chennai Province Tamil Nadu Country India Postal Code 600004 Number of Positions 4 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...
Posted 3 months ago
8.0 - 13.0 years
10 - 15 Lacs
Pune
Work from Office
Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and product...
Posted 3 months ago
4.0 - 9.0 years
9 - 19 Lacs
Bengaluru
Remote
Position: Clinical Programmer Experience: 4-9 Years Job Location: Remote Job Description: Minimum of 4+ years of experience in clinical programming for clinical data management in the pharmaceutical or CRO industry. Experience working with different EDC systems (e.g., Medidata Rave, Veeva, Oracle Clinical). Proficient in Python /SAS for data manipulation & automation. Experience in data cleaning , querying , and performing manual & automated data checks to ensure data integrity. Hands-on experience in data visualization and dashboard creation using Power BI , Spotfire , or other BI tools. Thorough knowledge of Data Collection and industry data standards . A person with bachelors or masters d...
Posted 3 months ago
4.0 - 9.0 years
10 - 15 Lacs
Mumbai, Pune, Mumbai (All Areas)
Work from Office
Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the informatio...
Posted 3 months ago
10.0 - 19.0 years
15 - 30 Lacs
Hyderabad, Bengaluru, Delhi / NCR
Work from Office
Job Location-- Noida/Gurgaon/Hyderabad/Kolkata/Bangalore/Mumbai/Pune/Chennai Develop tailored Veeva CRM solutions that address specific business needs and align with organizational goals. • Work closely with business analysts, stakeholders, and other technical teams to gather requirements and translate them into technical specifications. • Oversee the implementation and configuration of Veeva CRM, ensuring a seamless deployment in line with industry best practices. • Provide expert guidance on data management, system integrations, and any necessary system upgrades. • Create and maintain comprehensive documentation of system architecture, processes, and configurations for future reference. • ...
Posted 3 months ago
9.0 - 13.0 years
27 - 42 Lacs
Chennai
Work from Office
Job Summary The Sr Product Specialist (ISG) will play a crucial role in enhancing and managing our Veeva CTMS and Veeva systems within the Research and Development domain. With a hybrid work model and day shifts the candidate will collaborate with cross-functional teams to ensure seamless integration and functionality of these systems. This role requires a deep understanding of Veeva technologies and R&D processes to drive innovation and efficiency. Responsibilities Lead the implementation and optimization of Veeva CTMS and Veeva systems to support R&D activities. Oversee system configurations and ensure alignment with business requirements. Collaborate with stakeholders to gather and analyz...
Posted 3 months ago
1.0 - 6.0 years
10 - 15 Lacs
Bangalore Rural, Bengaluru
Work from Office
Hi, We are hiring for the Leading ITES Company for Medical Writing Role. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is ...
Posted 3 months ago
1.0 - 3.0 years
5 - 7 Lacs
Bengaluru
Work from Office
Overview About Role: We have an exciting role of Medical Editor - Analyst to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. About Omnicom Global Solutions Omnicom Global Solutions (OGS) is an agile innovation hub of Omnicom Group, a leading global marketing and corporate communications company. Guided by the principles of Knowledge, Innovation, and Transformation, OGS is designed to deliver scalable, customized, and contextualized solutions that meet the evolving needs of our Practice Areas within Omnicom. OGS India plays a key...
Posted 3 months ago
1.0 - 4.0 years
4 - 7 Lacs
Hyderabad
Work from Office
The Regulatory Data & Systems 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 Business Ana...
Posted 3 months ago
3.0 - 7.0 years
3 - 7 Lacs
Hyderabad
Work from Office
Role Description? This role involves working closely with Business Analyst Data architects, Data engineers, AI/ML engineers and Product Managers to ensure that Validation strategy and deliverables are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise , validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validatio...
Posted 3 months ago
2.0 - 5.0 years
3 - 6 Lacs
Hyderabad
Work from Office
About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. 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 lifecy...
Posted 3 months ago
2.0 - 5.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Job Title: Senior Associate, Labeling Compliance Overview In this pivotal role, you will support the planning, coordination, and execution of global labeling compliance initiatives within the Regulatory Affairs department. Working in a fast-paced, matrixed environment with no direct reports, you will collaborate extensively with cross-functional and regional teams—including Regulatory Affairs, Quality, Operations, and Supply Chain—to ensure that labeling meets all global regulatory requirements and maintains the highest standards of quality. This position offers a unique opportunity to lead initiatives, contribute to strategic projects, and drive continuous improvement, all while building st...
Posted 3 months ago
1.0 - 3.0 years
3 - 7 Lacs
Mumbai
Work from Office
Skill required: Marketing Operations - Digital Asset Management (DAM) Designation: Digital Content Management Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more tha...
Posted 3 months ago
1.0 - 3.0 years
2 - 6 Lacs
Bengaluru
Work from Office
Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in mor...
Posted 3 months ago
3.0 - 8.0 years
2 - 5 Lacs
Bengaluru
Work from Office
Project Role : Quality Engineer (Tester) Project Role Description : Enables full stack solutions through multi-disciplinary team planning and ecosystem integration to accelerate delivery and drive quality across the application lifecycle. Performs continuous testing for security, API, and regression suite. Creates automation strategy, automated scripts and supports data and environment configuration. Participates in code reviews, monitors, and reports defects to support continuous improvement activities for the end-to-end testing process. Must have skills : Veeva Vault Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education...
Posted 3 months ago
15.0 - 20.0 years
9 - 13 Lacs
Bengaluru
Work from Office
Project Role : Software Development Lead Project Role Description : Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills : Veeva Vault Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Software Development Lead, you will be responsible for developing and configuring software systems, applying knowledge of technologies, methodologies, and tools to support projects or clients. You will lead the software development proc...
Posted 3 months ago
3.0 - 8.0 years
5 - 9 Lacs
Bengaluru
Work from Office
Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with ...
Posted 3 months ago
3.0 - 8.0 years
5 - 9 Lacs
Bengaluru
Work from Office
Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with ...
Posted 3 months ago
15.0 - 25.0 years
5 - 9 Lacs
Bengaluru
Work from Office
Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NAMinimum 15 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will be involved in designing, building, and configuring applications to meet business process and application requirements. You will play a crucial role in developing solutions that align with organizational goals and enhance operational efficiency. Roles & Responsibilities:- Expected to be a SME with deep knowledge and experience.- Shoul...
Posted 3 months ago
3.0 - 8.0 years
5 - 9 Lacs
Bengaluru
Work from Office
Project Role : Application Designer Project Role Description : Assist in defining requirements and designing applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure c...
Posted 3 months ago
3.0 - 8.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Veeva Vault Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Offshore Migration Lead, you will oversee and coordinate offshore migration execution into the Veeva Vault platform. You will lead a team of migration specialists and analysts and BA, apply hands-on expertise in Vault migrations, SQL, and RDBMS, and collaborate with onshore counterparts to execute plans, manage timelines, resolve issues, and ensure compliance with qu...
Posted 3 months ago
5.0 - 10.0 years
15 - 20 Lacs
Bangalore Rural, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. 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 TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. ...
Posted 3 months ago
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