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3.0 - 8.0 years

10 - 14 Lacs

Bengaluru

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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...

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3.0 - 8.0 years

5 - 9 Lacs

Bengaluru

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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 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...

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8.0 - 12.0 years

10 - 14 Lacs

Hyderabad

Work from Office

About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Man...

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8 - 10 years

12 - 15 Lacs

Hyderabad

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Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality sta...

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4 - 8 years

17 - 22 Lacs

Bengaluru

Hybrid

Platform Engineer / Business Analyst - Veeva R&D Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Purpose and Scope: As a Platform Engineer of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components Digital Capability and Digital Execution. Digital Execution are about aligning multiple missions around b...

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6 - 8 years

14 - 17 Lacs

Hyderabad

Work from Office

The Senior Associate, Global Submission Management – Americas, 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 North American 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 and Regulatory submissi...

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5 - 10 years

4 - 7 Lacs

Hyderabad

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The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information. As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and system use. You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving deman...

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7 - 11 years

8 - 13 Lacs

Hyderabad

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The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. ...

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5 - 8 years

7 - 10 Lacs

Hyderabad

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The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

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10 - 15 years

30 - 45 Lacs

Mumbai, Gurugram, Delhi / NCR

Work from Office

Entity :- Accenture Strategy & Consulting Team :- Global Network Data & AI Practice :- Life Sciences Title :- Ind&Func AI Decision Science Manager Job Location :- Delhi, Gurgaon, Mumbai, Bangalore About S&C - Global Network :- Accenture GN's Data & AI (AI Hub India) practice helps our clients grow their business in entirely new ways. Analytics enables our clients to achieve high performance through insights from data - insights that inform better decisions and strengthen customer relationships. From strategy to execution, Accenture works with organizations to develop analytic capabilities - from accessing and reporting on data to predictive modeling to outperform the competition. WHAT'S IN I...

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3 - 7 years

20 - 25 Lacs

Bengaluru

Work from Office

Entity :- Accenture Strategy & Consulting Team :- Global Network Data & AI Practice :- Life Sciences Title :- Ind&Func AI Decision Science Manager Job Location :- Delhi, Gurgaon, Mumbai, Bangalore About S&C - Global Network :- Accenture GN's Data & AI (AI Hub India) practice helps our clients grow their business in entirely new ways. Analytics enables our clients to achieve high performance through insights from data - insights that inform better decisions and strengthen customer relationships. From strategy to execution, Accenture works with organizations to develop analytic capabilities - from accessing and reporting on data to predictive modeling to outperform the competition. WHAT'S IN I...

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1 - 6 years

3 - 8 Lacs

Gurugram

Work from Office

Research & Development Consultant – Life Sciences and Health Join our team in Strategy consulting to find endless opportunities and solve our clients toughest" challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Life Sciences & Health, Industry Consulting, Capability Network I Areas of Work: Research & Development (R&D) | Level: Consultant | Location: Delhi, Gurgaon, Mumbai, Bangalore Years of Exp: 3 -6 years Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your...

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5 - 7 years

17 - 22 Lacs

Bengaluru

Hybrid

Specialist, Records and Information Management (RIM) Purpose and Scope: Under the direction of the Lead of Global RIM, responsible for planning, developing, and administrating the Records and Information Management (RIM) program for our company. Provides consistent RIM guidance and leads RIM initiatives to ensure compliance with relevant regulatory, legal, and business requirements. Independently coordinates the resources necessary for successful execution of RIM projects, meets business objectives and ensures outstanding customer service. Requirements Responsibilities and Accountabilities: Job responsibilities cover various facets of the comprehensive Global RIM program across the company, ...

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7 - 10 years

30 - 40 Lacs

Bengaluru

Hybrid

Advisor, Records and Information Management (RIM) Purpose and Scope: Under the direction of the Lead of Global RIM, responsible for planning, developing, and administrating the Records and Information Management (RIM) program for our company. Provides consistent RIM guidance and leads RIM initiatives to ensure compliance with relevant regulatory, legal, and business requirements. Independently coordinates the resources necessary for successful execution of RIM projects, meets business objectives and ensures outstanding customer service. Job responsibilities cover various facets of the comprehensive Global RIM program across the company, including affiliates and sites. Responsibilities and Ac...

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3 - 5 years

13 - 19 Lacs

Bengaluru

Hybrid

Job Description Analyst, Records and Information Management (RIM) Purpose and Scope: Under the direction of the Lead of Global RIM, responsible for planning, developing, and administrating the Records and Information Management (RIM) program for our company. Provides consistent RIM guidance and leads RIM initiatives to ensure compliance with relevant regulatory, legal, and business requirements. Independently coordinates the resources necessary for successful execution of RIM projects, meets business objectives and ensures outstanding customer service. Responsibilities and Accountabilities: Job responsibilities cover various facets of the comprehensive Global RIM program across the company, ...

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1 - 6 years

0 - 3 Lacs

Bengaluru

Hybrid

Key Responsibilities: Participates in the estimation of activities, owns technical implementation of the SaaS application, and responsible for the design, configuration and integration for new and modified features for CTMS/eTMF and other Veeva Vaults. This role will have a keen focus to detail through ensuring Veeva applications is deployed using the framework of the Veeva Vault configuration standards and best practices. Works closely with business to understand the business requirements. Thinks critically to help them design the solution they actually need; not just the solution they think they need. Participates in the requirements workshops, design, prototype, configure and document Vee...

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3.0 - 8.0 years

5 - 15 Lacs

hyderabad, pune, chennai

Work from Office

Veeva Vault Exp: 5 to 8 Years Location: Bangalore Should have experience in Veeva QMS Veeva QDocs and RIMS Good experience in workflows and comprehensive audit trails for quality management of change controls CAPA deviations as well as supplier quality management and internal audit Understand complete workflow of authoring documents approval workflows and integrated repository to SAP SuccessFactors validated Support requirements Manage all Service Requests and Incidents troubleshooting the application and product related errors and issues Debugging and troubleshooting Interface related errors and issues Boomi and Java Providing application and business process related SME assistance on desig...

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5.0 - 8.0 years

4 - 8 Lacs

bengaluru

Work from Office

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Master of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes b...

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3.0 - 7.0 years

0 - 1 Lacs

hyderabad, pune, bengaluru

Hybrid

Veeva RIM L1 & L2 Support Tasks General User Management Provision User access requests & update requests including inactivation and profile updates Login/SSO issues Missing notifications Troubleshooting record level access control Periodic User Dormancy Bulk data creation/update/deletion User Education Related Queries Integration Data discrepancy(Inbound/outbound sync issues, Integration job failures) Monitor scheduled jobs Object records state change request Constraints/Control Vocabulary updates Content Plan template Creation/Updates/Deletion Submission Import activities Upload submission documents using loader Content plan generation issues Troubleshooting Permission issues related to doc...

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