44 Veeva Vault Jobs - Page 2

Role: EDC Programmer (Veeva Vault) Loc: Mumbai, Pune, Bangalore, Indore, Ahmedabad | Exp: Int’l BPO | No TCS rehires Skills: Veeva Vault EDC, CQL, CDB, JSON, C#, SAS/R/Python, Medidata Rave, Oracle Inform, CTMS, Data Warehouses Required Candidate profile Responsibilities: Design & program eCRFs in Veeva, configure SDV/SDR, edit checks Develop/test study rules, manage UAT, eTMF docs Post-go-live changes, impact analysis, QC

Role & responsibilities Role : Third Party Data Acquisition Study Analyst * Collaborate closely with the Third Party Data Acquisition Study Analyst to facilitate the setup and acquisition of external clinical data at the study level during study startup, conduct, and closeout phases. * Ensure data accuracy, completeness, and consistency through effective cleaning, validation, and transformation processes. * Monitor data feeds regularly to uphold data quality and accuracy. * Support the setup of infrastructure enabling external data integration into client's clinical data pipelines. * Provide guidance and coordination to vendors on data acquisition systems, including GlobalScape, Veeva FTP, Veeva training, and IP whitelisting. * Review incoming data from multiple sources to confirm compliance with Data Transfer Agreements (DTA) regarding format, file extensions, and field requirements. Validate all third-party data generated during clinical trials for integration into Clients clinical data ecosystem. * Assist the Third Party Data Acquisition Study Analyst in conducting periodic Trial Master File (TMF) reviews per the study TMF plan. * Adhere to procedural documents and participate in their review and updates to ensure alignment with industry standards, regulatory requirements, and best practices. * Coordinate with and review deliverables from external partners (e.g., labs, eCOA providers, technology vendors) performing services for Client. * Appropriately escalate issues to the Third Party Data Acquisition Study Lead. * Routinely monitor proprietary applications for scanned mail and distribute documents to relevant teams.Perform regular quality checks to ensure optimal system performance and data integrity. Preferred candidate profile

Veeva Platform Engineer - Payments 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 business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. An Enterprise Business Platforms Engineer focuses on the development, deployment, and integration of software platforms that support our business processes and operations. This role involves a blend of technical expertise, business acumen, and a deep understanding of Veeva Clinical Platform. The goal is to ensure these platforms are optimized to support business goals, enhance efficiency, and drive growth. You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field. Essential Job Responsibilities: Platform Development and Configuration: Design, develop, and configure business platforms to meet the specific needs of our organization. This could involve programming, configuring settings, and integrating various software solutions. System Integration: Ensure seamless integration between different business platforms and systems (e.g., integrating CRM and ERP systems) to enhance data flow and business processes. Performance Monitoring and Optimization: Regularly monitor the performance of business platforms, identify bottlenecks, and implement optimizations to improve efficiency and user experience. User Support and Training: Provide technical support to platform users, resolve issues, and conduct training sessions to ensure users can effectively utilize the platforms. Initiative Execution: Actively participate in and contribute to various initiatives, applying your specialized skills to achieve the objectives and expected Value. Contribute to the ongoing realization of Value from these enterprise platforms through continuous integration and deployment. Collaboration: Work collaboratively with team members within the subdivision and across other digital and business units. Continuous Learning: Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in a specific area of expertise. Innovation: Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities. Reporting: Regularly report on the progress of the various Value Teams and outcomes to your Capability Lead and team members. Problem-Solving: Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions. Quality Assurance: Ensure the highest quality and consistency in the work delivered. Requirements Qualifications: Required Bachelors degree in relevant field, e.g., Computer Science, Data Science Minimum of 3-5 years of demonstrated relevant experience Demonstrated experience in developing and configuring in the Clinical Operations space using Veeva Vault Payments Business Process Understanding: Knowledge of Clinical operations business processes and how Vault Clinical supports these processes Strong analytical and problem-solving skills Ability to work effectively in a team environment Excellent communication skills, both written and verbal Agile and adaptable to changing environments and project scopes Present technical solutions based on the business requirement of the Clinical Veeva system. Able to support technical upgrade on quarterly basis by conducting technical impact assessment, addressing any technical issues, support the environment management, support testing, and document changes per the SLC process Manage user account, create roles, and support quarterly user access review request. Support system deliverables and provide technical feedback during internal and external Veeva Clinical system audit Work closely with the internal privacy and security team to assess Personal Information requests and act according per the privacy laws Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during the technical upgrade Preferred Veeva Admin Certification 1-3 years demonstrated experience with Veeva Vault Clinical Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery Technical Proficiency: Strong coding skills in relevant tools and technologies, e.g., Java, C++, Python, R, SQL is highly beneficial

Job Title: Veeva Vault Clinical Engineer Experience: 5+ Years Location: Bengaluru, India (Hybrid 2 days/week in office) Note: Immediate to 30-day joiners preferred. About the Role: We are looking for an experienced Veeva Vault Clinical Engineer with a strong background in CTMS, eTMF, and CDMS (EDC) . The ideal candidate will have hands-on experience in Veeva Vault configuration, integration, and support activities. Youll work closely with cross-functional teams to support and enhance clinical trial systems, contributing to the smooth execution of clinical operations. Key Responsibilities: Configure and support Veeva Vault Clinical applications including CTMS , eTMF , and CDMS (EDC) . Perform system integrations, connections, and enhancements within the Veeva Vault ecosystem. Required Skills: Minimum 5 years of experience working with Veeva Vault Clinical Suite , particularly CTMS , eTMF , and CDMS . Strong hands-on experience in EDC build , configuration , integrations , and technical support . Familiarity with clinical trial processes and how they align with clinical systems is a strong advantage. Proven ability to demonstrate both technical and functional expertise in Veeva Vault systems. Excellent problem-solving, communication, and collaboration skills. Location: Bangalore, India – Hybrid model (2 days/week from office) Note: Immediate to 30-day joiners preferred.

The ideal candidate will have experience in graphic design with a focus on regulated environments and a strong understanding of pharma-specific packaging components such as labels, cartons, leaflets, and blister packs.

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

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 Veeva solutions. Implements Veeva suite of application to meet the business, functional, security and integration requirements either via configuration or custom development using Veeva Vault SDK. Participates in the testing and validation activities by helping in the creation and review of test scenarios, data staging, test executions and validation documents. Works with the Veeva support teams to provide technical solutions to production issues/integration issues. Experience: Experience working with or for Life Sciences companies; including, Pharmaceutical, Biotechnology, Healthcare, or Medical Device organizations with knowledge of drug development processes and regulatory submissions Solid experience in configuration in Veeva Vault and a strong learning attitude towards other vaults in Veeva. Exposure in Veeva Vault Data Model - Understanding of Products, eTMF, Clinical Studies, Sites. System implementation experience as developer for Veeva application. Desirable experience working with Veeva Vault SDK to deliver custom solutions by extending the application capabilities. Fair understanding of Veeva Vault data model, data loader and migration tools and technologies Understand and implement Veeva integrations (Vault to Vault / Vault to other systems or middleware like MuleSoft) Understanding of health care regulations, international regulations, and privacy controls Basic Qualifications : Bachelors Degree (or equivalent work experience) 3+ years of experience in Veeva application configuration/development Strong teamwork, self-management, problem-solving abilities Excellent oral and written communication skills Trained and Certified in Veeva Vault

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

EY- GDS Consulting Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation for pharma or medical devices and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers and Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in pharmaceutical industry in the areas of Quality Management System - Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix, Data Migration strategy and report etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written, oral and presentation skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA), ISO 13485:2016 – Medical Devices – Quality Management System Information Security (ISO 27001) or Risk Management certifications What we look for A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What working at EY offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you

Hi We are Hiring for ITES Company for the Pharmacovigilence Aggregate Reporting Role Job Location - Pune / Mumbai Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

About the department Regulatory Affairs CMC play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs CMC are involved throughout all phases of product development and roll-out. Our people in Regulatory Affairs come from many different academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities. The Position As a Senior Regulatory Professional, the candidate will be responsible for providing strategic input to RA CMC activities. One should have demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc. The professional will be required to handle most situations independently but will seek advice and guidance on complex issues. Further responsibilities include handling the change requests, query responses and provide strategic input at various forum representing RA CMC. Support preparation and submission of regulatory files, response to questions from health authorities and maintenance of marketing authorization globally. Negotiate with the regional affiliates on HA requirements and timelines. Manage stakeholders from across the organization including product supply. Hands on experience with Veeva vault and RIMS. The candidate will play a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders. Experience 9+ years of experience within Regulatory affairs CMC with Graduate / Postgraduate degree in science/ pharmacy/ medicine etc. Experience of working in a Biologics company is preferred. Good understanding of end to end regulatory processes and life cycle management. Strategic mindset with proven negotiation skills. Should be able to convince and put forward the facts confidently. Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results. High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones. Excellent written/spoken communication skills.

Job description Good experience in Veeva Vault CRM, Objects configurations and Access Control Management. Strong experience in Veeva vault API integrations and Authentication mechanisms. Good understanding of HCP Engage Services, Data Integrations and Publish expertise. Review of asset metadata and related configurations in Veeva DAMS Experience in Packaging, Completeness and follow internal specifications (naming conventions, size, etc..). Good understanding of Veeva vault best practices and integration standards. Maintenance of Digital Assets/Objects in Veeva vault • Tracking of expired assets • Expiry management • licensing extension • Keyword management A White belt certified On Veeva Vault platform will be a plus.

QMS Consultant & Veeva Vault Project Support Analyst Role Overview We are seeking a professional with expertise in Quality Management Systems (QMS) and Veeva Vault to support the implementation, migration, and optimization of quality management processes. This role will focus on document and data migration, regulatory compliance, system integration, and ongoing support for Veeva Vault applications. The candidate will work from 5:30 PM IST 2:30 AM IST to align with the US time zone . Key Responsibilities Quality Management & Compliance Provide subject matter expertise on Vault R&D migration and quality management . Ensure quality standards, GxP compliance, and regulatory requirements (e.g., ISO 9001) are met. Conduct risk assessments to identify compliance gaps and inefficiencies. Define document classification and approval workflows aligned with industry best practices. Develop, implement, and maintain standard operating procedures (SOPs) and workflows for quality management. Manage change control processes , ensuring minimal disruption to quality standards. Implement post-migration quality checks to ensure document integrity. Provide ongoing monitoring and support for quality management tools and systems integrated with Veeva Vault. Track quality metrics, risks, and issues in compliance reports. Veeva Vault Implementation & Support Assist in migrating data and documents into Veeva Vault , ensuring accuracy and compliance. Collaborate with cross-functional teams to gather requirements and align migration activities with project goals. Provide technical expertise on Veeva Vault functionalities, workflows, integrations, and best practices . Conduct data quality checks post-migration to validate completeness and integrity. Troubleshoot technical issues and provide system support. Optimize automation, reporting, and regulatory compliance tracking within Veeva Vault. Communicate with both technical and non-technical teams to bridge business needs with system specifications. Identify, assess, and escalate potential risks related to migration and system integration. Training & Stakeholder Engagement Develop and update training documents and job aids for new Veeva Vault practices. Work alongside the Training & Procedures Team to provide comprehensive end-user training. Conduct product demonstrations and stakeholder engagement sessions to ensure seamless adoption. Gather and address stakeholder feedback to improve system functionalities and compliance adherence. Required Skills & Experience Technical & Functional Expertise 3+ years of experience in Veeva Suite, Veeva Vault, and Quality Management Systems (QMS) . Prior experience with Veeva migration support, data/document migration, and metadata mapping . Experience working with Veeva Vault Quality Suite , including workflows, document types, reports, dashboards, and notifications. Strong understanding of GxP, ISO 9001, and software validation regulations . Hands-on experience in testing, script execution, and system troubleshooting . Experience in configuring and resolving issues in multiple Veeva Vaults . Soft Skills & Qualifications Veeva Admin Certification is required . Bachelors degree in life sciences, computer science, or a related field . Strong analytical, problem-solving, and attention to detail skills. Excellent communication and interpersonal skills to work collaboratively across teams. Ability to influence stakeholders and manage change control processes effectively. Highly organized and detail-oriented with strong documentation skills. This role is ideal for candidates who can blend technical expertise with quality management practices while ensuring seamless regulatory compliance, data integrity, and system optimization within Veeva Vault.

Job purpose The ideal candidate will be responsible for compiling, managing, and maintaining critical documents and data related to batch records, assay records, and other essential documentation in a highly regulated environment. This role is crucial for ensuring the accurate tracking, trending, and compliance of data. Duties and responsibilities Compile Data from Batch Records: Collect and organize information from batch production records, ensuring all relevant data is accurately recorded and easily accessible. Ensure batch records are compliant with Good Manufacturing Practice (GMP) standards and relevant regulatory guidelines. Compile and Review Assay Records: Gather and manage assay data, ensuring it is consistently and accurately recorded. Collaborate with laboratory teams to ensure timely and correct documentation of assay results. Data Tracking and Trending: Monitor and track production and assay data over time to identify any variations, trends, or issues. Develop and maintain data tracking systems to ensure that trends and variations are documented, evaluated, and reported effectively. Prepare and present regular trend analysis reports to management and other stakeholders. Document Control: Maintain a system of organized, up-to-date documentation related to batch and assay records, ensuring compliance with all regulatory requirements. Review and approve documents for accuracy, completeness, and consistency in line with established protocols and SOPs (Standard Operating Procedures). Compliance & Quality Assurance: Ensure all documentation adheres to regulatory requirements such as FDA, EMA, ICH, and GMP guidelines. Participate in internal audits, inspections, and document reviews to ensure compliance with industry standards. Qualifications • Master degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, or related field. • 5+ years of experience in document management or quality control within the biopharma. • Strong knowledge of GMP, GLP (Good Laboratory Practice), and relevant industry regulations. • Experience in compiling and managing batch records, assay records, and production data. • Proficiency in Microsoft Office Suite and document management systems (e.g., Veeva Vault). • Excellent organizational skills with a keen attention to detail. • Ability to manage multiple priorities in a fast-paced environment. • Strong analytical skills and experience with data trending and report generation.

Job Title: Regulatory Publishing Specialist SUMMARY Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs and JNDAs and their amendments and supplements in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, JP, ICH, etc). JOB RESPONSIBILITIES: • Electronically format and publish submission components in line with regional specifications. • Compile and validate electronic submissions in publishing software (Lorenz Docubridge) • Accountable for dispatching finalized submissions through the appropriate regulatory authority portal and archiving in Veeva. • Responsible for overseeing routine submissions, including the creation of submissions in Veeva. • Provides guidance on good documentation and submission practices. • Assist with developing and maintaining Regulatory document processing and Regulatory submission. publishing standards and procedures. • Identifies and communicates regulatory system enhancement needs or technical issues. • Assists with regulatory inspection activities. • Collaborates with vendors who support Regulatory submission document related tasks. • Provides support and backup to management as needed. JOB REQUIREMENTS: Education • Bachelors Degree Experience • Minimum of 2 years experience with Regulatory Operations • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). • Strong knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required. • Familiarity with Veeva Vault & Lorenz Docubridge would be advantageous. Requirements • Full-time, office-based position (5 days per week) • Working standard regional hours

Overview: Accountabilities: As the Senior Manager, you will lead the execution of the organization, verification, storage, and cataloguing of digital assets in the Content Centre (CC) DAM platform. You will partner with Content Excellence team leads to understand overall strategic direction for Content Reuse at Organization. Your role will also involve leading a librarian team that manages the day-to-day administration and execution of hosting Org content in CC. You will ensure high quality and consistency of digital assets within the CC platform, including implementation and governance of taxonomy, metadata, and other standards, aligned with regulatory guidelines. Essential Skills / Experience: Total 10+ yrs of experience with min 6+ years of work experience in operations, with direct experience in content management and content workflows Experience with Veeva Vault Very strong project management skills Experience in driving continuous process improvements and process automations Skilled proficiency in preparation of reports, presentations, summaries, and analysis Track record of effectively analysing and recommending solutions to the team/stakeholders for complex tasks Demonstrated ability to do cost benefit analysis, capacity management & business continuity management Ability to influence without authority and drive adoption/compliance Excellent written and verbal communication skills Experience in managing a team of direct reports Bachelors degree or higher Experience in pharmaceutical industry Familiarity with platforms (SNOW, JIRA Premium, Smartsheet) Experience in managing and partnering with diverse teams Experience in communicating with stakeholders in multiple geographies Strong listening and presentation skills Understanding of Omnichannel campaign workflows Understanding of Modular Content.

Veeva Vault Administrator with experience in GxP IT systems, Veeva Vault (RIMS/QMS) admin, system integration, and data migration. Responsibilities include release management, impact assessments, requirement coordination, and validation activities

Salesforce Development & Administration Develop and customize Salesforce applications using Apex, Visualforce, Lightning Components, and Salesforce APIs . Configure custom objects, workflows, validation rules, and security settings . Integrate Salesforce with third-party applications using REST/SOAP APIs and middleware. Implement CI/CD pipelines using SFDX and Azure DevOps. Provide technical support, troubleshoot issues, and ensure system stability. Veeva Vault & Veeva CRM Support Configure, maintain, and support Veeva Vault applications (Vault QMS, Vault QDocs, Vault RIM). Manage Veeva CRM user profiles, permissions, and territory management. Troubleshoot and resolve Veeva Vault and CRM issues. Assist with Veeva system upgrades, patches, and new releases. Develop reports and dashboards for performance tracking and business decision-making. Preferred Qualifications & Skills 5+ years of experience in Salesforce Development and Veeva Vault Applications. Strong expertise in Apex, Visualforce, Lightning Web Components (LWC), and Salesforce APIs. Hands-on experience with Veeva CRM and Vault applications (QMS, QDocs, RIM). Experience integrating Salesforce and Veeva with third-party applications. Knowledge of CI/CD tools (SFDX, Azure DevOps) for deployments. Strong troubleshooting and debugging skills. Excellent communication skills and ability to work in an agile environment Benefits Our robust employee benefits package includes comprehensive health insurance, and flexible paid time off, ensuring our team feels valued and supported. We prioritize work-life balance and personal well-being, fostering a positive workplace culture. By investing in our employees, we enhance job satisfaction and drive organizational success. Some of our employee benefits are listed below: Medical Benefits: Medical insurance coverage for employee and family members Earned Leave Encashment every year Gratuity