129 Veeva Jobs - Page 3

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 strong partnerships across the organization. Key Responsibilities 1. Labeling Strategy and Execution Coordinate day-to-day labeling activities, ensuring timely updates and compliance with global regulatory requirements. Serve as a key contact for cross-functional teams, providing operational support and guidance on labeling procedures, formats, and timelines. Execute labeling change requests, track progress, and maintain accurate documentation in labeling management systems. 2. Cross-functional Collaboration in a Matrix Organization Collaborate with global and regional stakeholders (Regulatory Affairs, Quality, Operations, Supply Chain) to streamline labeling processes and ensure alignment across multiple time zones. Identify and escalate potential compliance risks or delays in labeling updates, partnering with relevant teams to resolve issues efficiently. Proactively engage with global affiliates to gather requirements, clarify expectations, and facilitate smooth implementation of labeling changes. 3. Process Improvement and Compliance Contribute to continuous improvement initiatives, optimizing labeling processes, templates, and workflows to enhance efficiency and compliance. Support the maintenance of inspection readiness by ensuring that documentation, SOPs, and labeling processes adhere to quality standards and internal policies. Collect and analyze data on labeling operations, recommending improvements to enhance transparency, speed, and accuracy. 4. Stakeholder and Vendor Coordination Collaborate with vendors involved in labeling activities (e.g., translation services, artwork vendors) to ensure they meet quality and timeline requirements. Assist in monitoring vendor performance against established SLAs, promptly highlighting any gaps or issues to internal partners. Participate in regular meetings with internal and external partners to align on project deliverables, address operational challenges, and drive timely completion of milestones. 5. Training and Knowledge Sharing Provide guidance and operational support to junior staff and peers on labeling compliance processes, best practices, and quality standards. Help develop or refine training materials and job aids, promoting consistent understanding and application of labeling procedures across teams. Stay updated on emerging regulatory requirements and industry trends, sharing insights that could impact labeling strategies and practices. Basic Qualifications: Doctorate degree OR Master’s degree and 2 to 4 years of directly related experience OR Bachelor’s degree and 4 to 6 years of directly related experience OR Diploma and 8 to 10 years of directly related experience Equivalent combinations of education and experience may be considered. Preferred Qualifications Experience working with labeling management systems (e.g., Veeva Vault) or other document management platforms. Familiarity with global labeling regulations and end-to-end labeling processes. Demonstrated ability to plan and manage projects in a matrix organization, meeting deadlines and handling multiple tasks effectively. Strong collaboration and communication skills, comfortable working with international teams across time zones. Proven problem-solving capabilities, with an analytical mindset and attention to detail. Experience in vendor coordination, ensuring quality and compliance with established metrics.

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 than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Responsible for uploading and managing assets with standard Taxonomy (correct metadata tagging) and correct Digital rights management in Digital Asset Management system making it available for reuse. Subject matter expert in key concepts, process flows and defined scope of librarian tasks. Suggest workarounds and highlight anomalies when faced with technical challenges in the toolWork effectively with team members and requestors, understand the requirements and provide appropriate solutionsAssist users in concerns around the upload process. Take initiatives to learn new skills What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationshipGraduate required.Minimum 2-3 year of experience in upload and download of digital assets, content management, ensuring quality of content and meeting the minimum requirements of content standards as set by the clientBasic knowledge of Pharma industry and marketing operationsExperience in working on DAM platform (Digital Asset Management)Experience in any of the DAM platform (example Aprimo, Veeva)MSOffice - Able to effectively use MS Excel, MS Outlook, MS PowerPointHas excellent verbal and written communication skillsExperience participating in a collaborative team environmentHighly organized, detail oriented, and results focusedDemonstrate ability to think strategically Roles and Responsibilities: Perform quality checks on assigned daily tasks.Refer to the process change log and QC checklist for daily updates to ensure adherence to the latest guidelines.Perform QC on documents per process updates and checklistComplete the daily BAU tracker accurately, including correct verdicts in Workfront, and close tickets promptly.Ensure daily accuracy in the BAU tracker and correct verdicts in Workfront tickets.Possess end-to-end knowledge of all documents.Avoid client escalations and errors identified by leads, as these are considered external errors. Qualification Any Graduation

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 more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com 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 - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs LCM with Veeva skill set of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to perform under pressureProblem-solving skillsDetail orientationResults orientationStrong analytical skillsLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

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 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 quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

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 process from end-to-end or for specific product lifecycle stages. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Lead and mentor junior team members.- Drive innovation and continuous improvement in software development processes. Professional & Technical Skills: - Must To Have Skills: Proficiency in Veeva Vault.- Strong understanding of software development lifecycle.- Experience in leading software development projects.- Knowledge of agile methodologies.- Excellent communication and leadership skills. Additional Information:- The candidate should have a minimum of 12 years of experience in Veeva Vault.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

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 quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

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 quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText. -The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

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.- Should have Influencing and Advisory skills.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Lead the development and implementation of Veeva Vault applications.- Collaborate with cross-functional teams to gather requirements and design solutions.- Provide technical guidance and mentorship to junior team members. Professional & Technical Skills: - Must To Have Skills: Proficiency in Veeva Vault.- Strong understanding of data security and compliance.- Experience in integrating Veeva Vault with other enterprise systems.- Knowledge of Veeva Vault configuration and customization.- Good To Have Skills: Experience with Veeva CRM. Additional Information:- The candidate should have a minimum of 15 years of experience in Veeva Vault.- This position is based at our Bengaluru office.- A 15 years full-time education is required. Qualification 15 years full time education

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 compliance with quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

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 quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

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. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 95 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 98

Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data lake and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Pune ) Type : Job Code # 89 b) To Apply for above Job Role ( Mumbai ) Type : Job Code # 90

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. • Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. • Associate should be able to manage communication with customers, track and ensure quality on-time deliverables • Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. • Experience in SDTM, ADAM & TLF • Experience in EDC & VEEVA • Expertise in Base and Advance SAS programming. • Expertise in developing macros and developing generalized programs. • Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. • Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. • Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 91 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 92

Hi, We are hiring for Leading ITES Company for Clinical Data Management Profile. Plz apply and we shall call back the relevant profiles. Role & responsibilities: Minimum 3 years experience is required as a Leading Clinical Studies/ Clinical Data Management 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 regulatory 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. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 95 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 98

Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data lake and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 87 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 88

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 quality standards. Roles & Responsibilities:-Lead and mentor a team of offshore migration specialists handling execution of document and metadata migration tasks.-Review deliverables and ensure adherence to migration standards, best practices, and compliance expectations.-Manage work allocation, backlog tracking, and progress reporting for offshore migration tasks.-Monitor the completion of daily/weekly migration targets, ensuring on-time and accurate delivery.-Perform root cause analysis on migration errors and coordinate with technical teams to resolve Vault Loader or API issues.-Validate output quality through spot checks, sampling, and test case validations.-Provide hands-on support when needed for migration jobs, SQL-driven data transformation, and validation checks.-Troubleshoot migration errors using Vault logs and work with developers or Vault SMEs to resolve blockers.-Act as the primary offshore contact for the onshore Migration Lead or Project Manager.-Ensure the offshore team follows controlled migration procedures and documentation protocols.-Maintain audit trails, job trackers, and version-controlled artifacts. Professional & Technical Skills: Must To Have Skills: Hands-on experience with Vault Loader and Vault REST APIs for document and object migration.-Strong command of SQL for data extraction, transformation, and validation.-Experience working with CSVs, XML, JSON payloads, and migration packaging.-Strong leadership and coordination skills in an offshore delivery model.-Excellent communication skills for daily sync-ups, reporting, and issue escalations.-Attention to detail, quality orientation, and ability to manage workload under deadlines.-Familiarity with regulatory requirements in GxP, 21 CFR Part 11 contexts.-Familiarity with Vault metadata models, document types, lifecycles, and object structures.-Experience with PromoMats / MedComms / Quality Suite / RIMS / Clinical and other Vault domains.-Proficiency in working with RDBMS like Oracle, SQL Server, PostgreSQL, or MySQL.-Experience in writing complex joins, subqueries, case statements, and data cleansing scripts.-Familiarity with legacy content/document systems such as Documentum, SharePoint, Calyx Insight, OpenText.-The candidate should have experience leading offshore migration teams for Veeva Vault projects.-Prior experience in regulated environments (GxP, 21 CFR Part 11) is required.-A minimum of 3-5 years of experience in Vault migrations is expected. Additional Information:-The candidate should have a minimum of 3 years of experience in Computer System Validation (CSV).-This position is PAN-INDIA based.-A 15 years full-time education is required. Qualification 15 years full time education

Roles and Responsibilities Manage digital assets throughout their lifecycle, ensuring data quality assurance and metadata management. Collaborate with cross-functional teams to resolve issues related to asset lifecycle management and reporting documentation. Ensure effective team collaboration through clear communication channels and issue resolution processes. Provide system support for DAM tools such as Aprimo, AEM, Sitecore, Veeva, and other relevant platforms. Desired Candidate Profile 4-9 years of experience in Digital Asset Management (DAM) or a related field. Strong understanding of Data Quality Assurance principles and practices for managing large datasets. Proficiency in using various DAM tools such as Aprimo, AEM, Sitecore, Veeva etc. . Excellent organizational skills with attention to detail for maintaining accurate records and reports.

Hi, We are looking to hire someone for Study Data Manager Please go through the JD, we shall call back the relevant Profiles a) Experience in leading clinical studies. b) Experience on Study Conduct and Close Out JOB DECSRIPTION: Need exposure to Inform or Medidata Rave database Responsible & Accountable for the assigned study conduct activities, in clinical trials Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies. To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory). SPOC for the study communications Proactively highlight any risks associated with the study along with the mitigation plan. Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines. Identify process Improvement opportunities and ensure learning is shared Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality. Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas. Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 184 b) To Apply for above Job Role ( Pune ) Type : Job Code # 185 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 186

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183

Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183

Hi , We are hiring for Leading ITES Company for SDTM Programmer Profile. Please go through the JD and we will get back to the relevant profiles. Job Description: Minimum 3 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 208 b) To Apply for above Job Role ( Pune ) Type : Job Code # 209

Hi We are Hiring for the job role of Medical Writer Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57

Experienced in documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market. Or emerging market like Africa. ROW - rest of the world market Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool

Job Description: Assist and manage (as applicable) in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components. Support and delivery of submission ready packages to agreed timelines and management of information required. Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications. Prior experience in Veeva vault is preferable. Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables. Develop research skills relevant information, regulations, and guidance from different regulatory agencies. Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination. Assist in the preparation of agendas, presentations, and other supporting materials for various meetings. Contribute to the development and improvement of related business processes. Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required. Ensure the learning from own projects are shared with other colleagues/within the functions. Skills Required : Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool Good Knowledge Documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market.

Job Title/Description: Associate MPD Process AMA PHC, BB Duration: 1 year in the beginning [ basis business need & performance may be continued further] Required Qualification & experience: M. pharm. Pharmaceutics Location: GOA, Mumbai Note: Third Party Payroll Job - Ashkom Media India Pvt LTD. Required Skills: Work Experience: 3 - 5 years in pharmaceutical Formulation development + Technology Transfer. Formulation development + stability study management Roles: To assist in making QC Soft entries for report generation of various stability results compilations, Raw material samples co-ordination, protocol, report review To support to MPD Process/ADL technical team in making batch records & other MPD Technical documentation To support in indent, receive of raw material and analysis at MPD Goa lab. To support MPD - Process Team in Enovia Technical specification data management To assist in reviewing of various technical documents (e.g. PV Protocol- Reports, TT, MFR) of which draft is shared by respective project leader of MPD To assist the team in raising purchase request in Coupa software. To participate in other tasks i.e. Office administrative task assigned by MPD-GO Mumbai 8) To Help MPD Process technical team members in Change control management, Department SOP review, issuance management Responsibilities To raise Change control in Veeva GTRAQ QA system for MPD depts. in scope CCPs. Scope- CCPS to be raised for MPD teams located at different locations PAN India) To maintain track of on-going/work in progress CCPs /closer of change controls To keep track of timely completion of action items (In scope- CCPs raised by MPD )& to maintain action log of work completed/ongoing & pending action items. Support to MPD Process/ADL technical team in making batch records & other MPD documentation. QC Soft entries for report generation of various stability, Raw material samples, protocol printing. Supporting MPD/ADL Team at Goa (through email & Team space, common folders) for Sending samples for outside testing with proper documentation To participate in other tasks assigned by MPD- team members e.g., TT document review Supplier qualification technical document review, To liaison with RM suppliers for receipt of material qualification document, safety document & its review. Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pin code - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com