124 Veeva Vault Jobs

Dear Candidate Greetings from Technogen !!! We thank you for taking time about your competencies and skills, while allowing us an opportunity to explain about us and our Technogen, we understand that your experience and expertise are relevant the current open with our clients. About Technogen : https://technogenindia.com/ Technogen India Pvt. Ltd. is a boutique Talent & IT Solutions company, founded in 2008, has been serving global customers for over last 2 decades,. Talent Solutions: We assist several GCCs, Global MNCs and IT majors on their critical and unique IT talent needs through our services around Recruitment Process Outsourcing (RPO), contract staffing, permanent hiring, Hire-Train-Deploy (HTD), Build-Operate-Transfer (BOT) and Offshore staffing. Job Title : Veeva Reg One/RIMS Required Experience : 5+ Years Location : PAN India Job Summary:- Veeva Reg One/RIMS Configure and customize Veeva Vault RIMS and Reg One modules, including document types, lifecycles, workflows, and security settings Develop and maintain submission document management, health authority correspondence, and commitment tracking Create and manage roles, profiles, workflow actions, entry/user actions, and notification templates Perform data migration and reconciliation using Vault Loader and other tools Preferred - Lead end-to-end implementation of Veeva Claims, Vault RIM, and Reg One modules. Life Sciences / Healthcare / FMCG / Regulatory Compliance

Veeva Vault-RegulatoryOne Administrator: The Veeva Vault-RegulatoryOne Administrator oversees the maintenance, development, implementation and roll-out of Veeva RegulatoryOne for UPL Regulatory Affairs. RegulatoryOne is the application used by Regulatory Affairs team to manage regulatory data and documents to run regulatory activities primarily. UPL adopted RegulatoryOne globally in 2022 and is continuously extending the scope and features. Our objective is to leverage RegulatoryOne for the benefit of other functions such as Marketing or Supply Chain by integrating with their IT applications (ERP, CRM, etc.). The focus for the next 12 months will be on dossier management (binders), document request workflow, and Registration Dossier Management (RDM). ROLES AND RESPONSIBILITIES : Understand the Customer business requirement and processes and translate them into a successful Application design. Collect business requirements from internal stakeholders to create and enhance innovative digital solutions or features. Administer the regulatory content management solution, i.e.: Organize, monitor, and maintain documents, data, user groups, templates, and reports as business administrator, Manage User access and security settings, document types and objects, Monitor, maintain, and troubleshoot lifecycles, workflows, atomic security and Dynamic Access Control Configure the Application or manage the contractor, if any. Manage the Product Backlog. Coordinate with IT functions regarding infra, security, system interconnexion, etc. Work on integration with other applications. Guide Data Analytics team to create dashboards. Update documentation detailing the configuration & customization Manage data and document migration to the Application when necessary. Set up and roll out training sessions to digital applications to end-users (incl. refresh sessions) to ensure a high level of adoption. CORE SKILLS Veeva RegulatoryOne / Vault configuration & customization Document management (classification, fields, field dependencies) Object management Lifecycles & Workflows Security management (incl. Matching rules, Custom Sharing Rules, etc.) Reporting & Dashboards RDM feature (Requirements, Split rules, Relational Tokens, Local Impact Assessment) Optionally SDK Running APIs (Postman) IT Application integration Business Process Management. Document and Data management. Optionally Agile Project Management methodology. Excellent oral communication in English. SOFT SKILLS High-Quality Work driven. Stakeholder/customer oriented. Autonomous (manager on remote) Rigorous. Team player IT TOOLS Veeva Vault, ideally RegulatoryOne Microsoft 365 Data visualization applications (e.g. Power BI, Qlik Sense)

Dear Candidate Greetings from Technogen !!! We thank you for taking time about your competencies and skills, while allowing us an opportunity to explain about us and our Technogen, we understand that your experience and expertise are relevant the current open with our clients. About Technogen : https://technogenindia.com/ Technogen India Pvt. Ltd. is a boutique Talent & IT Solutions company, founded in 2008, has been serving global customers for over last 2 decades,. Talent Solutions: We assist several GCCs, Global MNCs and IT majors on their critical and unique IT talent needs through our services around Recruitment Process Outsourcing (RPO), contract staffing, permanent hiring, Hire-Train-Deploy (HTD), Build-Operate-Transfer (BOT) and Offshore staffing. Job Title : Veeva Vault Developer Required Experience : 5+ Years Location : PAN India Job Summary:- Proven experience in implementing and configuring Veeva Vault applications Design and develop workflows and lifecycles for objects and documents within the Veeva Vault platform Customize object structures, fields, and relationships within the Vault data model Configure Claims Management settings including claim tiers, statement uniqueness, and local adaptations Integrate Veeva Vault with other enterprise systems ensuring data security and compliance Configure Claims Management settings including claim tiers, statement uniqueness, and local adaptations Life Sciences / Healthcare / FMCG / Regulatory Compliance

Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, FDA). Identify and resolve data inconsistencies and protocol deviations. Collaborate with clinical operations to ensure accuracy and completeness of source documentation. Support audit readiness through rigorous documentation practices and participation in quality reviews. Assist in creating source documents from protocols, CRFs, and lab manuals. Drive timely completion of data cleaning and database lock activities. Track and report key metrics for data quality and operational efficiency. Process Development & Compliance Develop SOPs, training guides, and implement process improvements. Identify inefficiencies and propose solutions to enhance workflow and team productivity. Participate in audits and collaborate on regulatory responses. Promote adherence to industry and internal standards. Cross-Functional Collaboration Serve as the point of contact for clinical data inquiries across assigned studies. Coordinate timelines and deliverables with project managers, monitors, and external stakeholders. Support all phases of the clinical study lifecycle from initiation to close-out. Qualifications and Experience Bachelor's degree in life sciences, health sciences, nursing, or a related field. Minimum 12 years of relevant experience, with at least 7 years in a Clinical Research Coordinator or Clinical Data Management role. Prior Managerial experience is a plus; must exhibit ability and willingness to take on supervisory responsibilities. Strong knowledge of CTMS (e.g., CRIO) and EDC systems such as RAVE, Veeva Vault, Clinical One, and Inform. Solid understanding of GCP, HIPAA, ALCOA-C, and clinical trial protocol standards. Must demonstrate ability to read, interpret, and operationalize clinical protocols. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to work independently while building processes and guiding others. Willingness to align with US operating hours.

Dear candidate Hiring for Top MNC Client Notice: Immediate or 10 days Location: Bangalore We are looking for a person who has experience in Veeva Vault development not an end user Job Title: Veeva Vault Application Manager-Proficient Experience Level: 10+ yrs Job Description: Mandatory Skills: *Veeva Vault , *CTMS , Quality Docs, Promo mats, RIM, eTMF, *Clinical Operations, Research & Development. Extensive knowledge on managing Quality Processes such as Deviations, CAPA, Audits, change control and Investigations. Handling Veeva features Release and Project Release activities, Impact Assessments, analyze and plan appropriate actions on data remediation/data enrichment. Own and maintenance of business and technical documentation i.e. SOP's and work instructions as per compliance requirement. Troubleshoot and resolve issues with Vault connections to ensure seamless operation. Subject Matter Expert in CTMS Payment Module, handling data remediations, cleansing, and analysis, managing document template and deployment to higher environments. Perform Change management review and approvals for Business and Veeva release for core configuration and integration areas. Provide internal leadership and work with third party vendors in case of escalations Modelled management and organizational skills and multi-tasked and prioritized in deadline driven environment. For the Application Manager role, : Minimum 7 to 8 years of relevant experience Strong technical configuration knowledge and hands-on experience with Veeva Vault CTMS / RIMS / QualityDocs / QMS Functional knowledge or exposure to business processes in any of the above Vaults Proven experience in application management, including incident management and handling change requests Experience in release management and validating applications during releases Ability to manage stakeholder communication to assess and prioritize release features Understanding of GxP validation processes, documentation, and the software development lifecycle (SDLC) Application manager - Advance beginner: 4+ years of IT exp with at least 2+ years in Veeva vault Experience in Veeva vault - Clinical Operations, Quality, RIM Experience as Functional consultant - a profound knowledge of business processes in Commercial (incl. Medical Affairs) or/and R&D (Research & Development) Veeva vault certification (Platform, eTMF, RIM etc.) added advantage Application Manager - Competent: 6+ years of IT exp with at least 4+ years in Veeva vault Experience in Veeva vault - Clinical Operations, Quality, RIM Experience as Functional consultant - a profound knowledge of business processes in Commercial (incl. Medical Affairs) or/and R&D (Research & Development) Veeva vault certification (Platform, eTMF, RIM etc.) added advantage

Primary Job Responsibilities: • Translate and prioritize business needs into technical and analytical requirements that feed into product development and overall design. • Clearly communicate technical concepts to non-technical clients and stakeholders. • Lead development efforts as a liaison with business and technical partners, including managing stakeholder expectations, requirements gathering, quality assurance, implementation, user adoption, and change management. • Work with engineers to draft requirements, statements of work, budget estimates, scope definitions, timelines, and supplier line-ups. • Set up tools and processes to facilitate communication and collaboration between team members. • Work with internal and external clients on identifying unresolved business needs to guide the teams product strategy. • Build and develop relationships with internal and external partners. Profile Looking for: • Experience leading software products from inception through launch and iteration in an Agile environment • The ability to break down problems from high-level ideas and objectives into successful products. • Experience with data-informed decision making through testing, experimentation, and analysis. • An eye for user experience and human-centered design • Experience working closely with engineers. • Communicate in a clear, convincing, and organized manner, with the ability to synthesize and summarize what matters to stakeholders. • Ability to balance priorities and make well-reasoned tradeoffs. • Eager to learn and thrive in a growing and fast-moving company. • High aptitude for collaboration and consensus building • Experience in the healthcare or clinical trial market is preferred. • Experience managing products for external stakeholders. • Familiarity with global technology trends and experience working in emerging markets. • A design or engineering background • Experience in building B2B platforms (preferred) • Product experience in data reporting and workflow tools is a plus. • Experience working with external partners in a product management role. • Design minded, empathetic and data driven. • Ability to make informed decisions while synthesizing the input of engineers, designers, external clients, and internal stakeholders

At EY, you will have the opportunity to shape a career tailored to your unique qualities, supported by a global network, inclusive environment, and cutting-edge technology to empower you to achieve your full potential. Your distinctive voice and perspective are essential in contributing to EY's continuous improvement. By joining us, you will not only create an exceptional journey for yourself but also contribute to building a more efficient and inclusive working world for all. As the EY GDS Consulting Veeva Systems Leader in the Life Sciences sector, you will play a crucial role in driving the establishment and expansion of our Veeva capabilities. This will involve overseeing the implementation of Veeva applications in both R&D and commercial domains. Your responsibilities will include shaping the go-to-market strategy, fostering global collaboration, recruiting and leading a high-performing team, and supporting the transformation of pharmaceutical operations across R&D and Commercial functions. Veeva Systems is a preferred partner for 85% of the top 20 Pharmaceutical companies, offering strategic value in both commercial and R&D aspects. EY anticipates significant opportunities in assisting clients with Veeva platform transformation over the next 3-4 years, necessitating a strong leader to position EY as a market leader in this domain. Your role will also involve spearheading industry cloud initiatives for life sciences, providing integrated solutions encompassing clinical, regulatory, quality, safety, medical, and commercial sectors. By leveraging Veeva's platform and solutions, you will drive growth, innovation, and delivery excellence to transform client operations and outcomes. Within the expanding landscape of EY GDS Consulting across global markets, your role will be pivotal in scaling Veeva-based transformation programs across the Americas, EMEIA, and APAC regions. Collaboration with global EY stakeholders and Veeva Alliance/vendor teams will be instrumental in delivering impactful solutions to pharmaceutical, biotech, and medtech clients. Your key responsibilities will include: - Leading the Go-to-Market strategy for Veeva solutions, focusing on R&D and expanding into Commercial pharma. - Developing differentiated solutions for life sciences clients using Veeva Vault and integrated platforms. - Mentoring and leading a high-performing team responsible for Veeva GTM, operations, and continuous improvement. - Overseeing Veeva capability development across GDS locations and ensuring timely, quality delivery of Veeva implementations and enhancements. - Acting as the primary liaison between GDS Veeva teams and global Veeva Centers of Excellence to ensure alignment with overall strategies. - Demonstrating deep expertise in Veeva platforms and solutions, with a strong understanding of life sciences workflows and compliance requirements. To excel in this role, you should have: - 15-20 years of experience in technology consulting, with a focus on life sciences. - Extensive expertise in Veeva platforms and solutions, particularly in Clinical, Regulatory, Quality, Safety, and Commercial domains. - Proven track record in selling and delivering large-scale Veeva programs and engaging C-level stakeholders. - Educational background in Life Sciences, Computer Science, or related fields, with professional certifications in Veeva Vault platform being advantageous. By joining EY as the Veeva Systems Leader in the Life Sciences domain, you will have the opportunity to drive impactful transformations, contribute to the growth of our global consulting practice, and shape a better working world for all stakeholders.,

Position: Veeva Vault QMS Developer Experience 7 Years to 9 Years Employment Type: Full Time Remote Note: If a candidate is strong in Technical, Budget may increase. Key Responsibilities / Skills: Configure and customize Veeva Vault QMS applications Develop objects, workflows, lifecycles, and security policies Create and maintain system integrations (APIs, middleware) Ensure compliance with validation and regulatory requirements Provide technical support during implementation and upgrades Perform system troubleshooting and root cause analysis Create deployment documentation and user guides Collaborate with BAs, QA, and business teams for solution delivery Hands-on experience with Vault APIs and SDK Experience in pharma/clinical regulatory systems Position: Veeva QMS Business Analyst Experience: 7 Years to 9 Years Employment Type: Full Time Location: Remote Note: If a candidate is strong in Technical, Budget may increase. Key Responsibilities / Skills: Gather, analyze, and document requirements for Veeva QMS solutions Translate business needs into functional and technical specifications Conduct stakeholder workshops, requirement walkthroughs, and UAT Collaborate with QA/Validation teams for compliance Strong experience in Life Sciences / Pharma processes Knowledge of GxP, FDA, and regulatory standards Prepare BRD, FRS, and user stories for implementation Support change management and training activities Act as liaison between business and technical teams Experience in Agile/Scrum delivery methodologies Position: Veeva QDocs Business Analyst Experience: 7 Years to 9 Years Employment Type: Full Time Location: Remote Note: If a candidate is strong in Technical, Budget may increase Key Responsibilities / Skills: Gather and analyze business requirements for Veeva QDocs Document current vs future process flows Define functional requirements and configuration specifications Conduct UAT sessions with business users Support validation, compliance, and audit readiness Collaborate with developers for enhancements and fixes Provide end-user training and adoption support Strong knowledge of pharma regulatory processes Excellent stakeholder and communication skills Experience in Agile documentation and delivery

The position is based in Hyderabad and you must be available for a face-to-face interview for the second round. Your primary responsibilities will include collaborating with business stakeholders to streamline end-to-end clinical operations processes and translating business requirements into technical specifications for development teams. You will define and communicate the product feature vision, ensuring alignment with business objectives and collaborating with stakeholders to design, implement, and manage Clinical Operations solutions. As part of the role, you will create a strategic roadmap for Veeva Vault Clinical Operations applications, oversee the software development lifecycle, and lead technology initiatives using the Scaled Agile Framework (SAFe). You will also be responsible for leveraging AI/ML and cloud technologies to address Clinical Operations needs and ensuring compliance with regulatory requirements. The ideal candidate should have experience in Veeva Vault Clinical Operations implementation and management, gathering business requirements, and converting them into technical solutions. You should possess strong leadership skills, the ability to mentor and develop team members, and excellent collaboration and communication skills. Familiarity with agile project management systems like JIRA and knowledge of regulatory requirements for Clinical Trials are essential. Preferred qualifications include extensive experience in the software development lifecycle, familiarity with Scaled Agile Framework (SAFe), and strong analytical and decision-making abilities. Professional certifications such as ITIL, SAFe for Teams, and Veeva Vault platform are preferred. In addition to technical skills, soft skills such as leadership, change management, collaboration, communication, and the ability to work effectively in global, virtual teams are important for success in this role. If you are interested in this opportunity, please share your resume with the provided email address. We look forward to receiving your application.,

Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC and/or Device submissions and related communications in the document management system Initiate and maintain CMC product and/or Device timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Doctorate degree OR Master's degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor's degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience managing or hovering staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

In this critical leadership role, the Senior Manager, Global Labeling Compliance will oversee the planning and execution of global labeling compliance initiatives for our portfolio. You will lead a dedicated team of labeling professionals and work cross-functionally to ensure all labeling activities meet regulatory, quality, and operational standards. As a key liaison between regional and global stakeholders, your leadership will ensure the timely and accurate delivery of labeling across multiple markets. This role is vital to ensuring our organization remains at the forefront of compliance and innovation in the biotech industry. Key Responsibilities: 1. Leadership & Team Management: Manage and develop a team of labeling specialists, providing direction, mentorship, and performance feedback to foster professional growth. Create a collaborative environment , guiding cross-functional teams to meet global labeling objectives and deliverables. Set clear goals and priorities for the labeling team, ensuring alignment with broader Regulatory Affairs and organizational strategies. 2. Labeling Planning & Execution: Oversee end-to-end labeling projects , from content creation and revisions to final implementation, ensuring on-time, in-full delivery of labeling materials. Coordinate across functions (e.g., Regulatory Affairs, Quality, Operations, Supply Chain) and regions to manage complex labeling changes and meet international requirements. Develop and manage project plans , defining timelines, milestones, and resources, and proactively identifying and mitigating potential risks or delays. 3. Compliance & Inspection Readiness: Ensure alignment with global regulatory requirements and company standards, maintaining consistent inspection readiness across labeling activities. Implement effective controls for tracking, auditing, and updating labeling content, ensuring accurate and compliant product information. Collaborate with Quality Assurance teams to address and close any compliance gaps or findings from audits, ensuring ongoing compliance. 4. Stakeholder Management: Manage relationships with external vendors , such as translation and artwork providers, by setting clear Service Level Agreements (SLAs) and key performance indicators (KPIs) to ensure optimal performance. Communicate effectively with global teams, regional affiliates, and third-party partners, maintaining transparency and driving successful outcomes across labeling processes. 5. Continuous Improvement & Systems Optimization: Identify and implement opportunities to enhance labeling workflows and processes, driving efficiencies and cost savings without compromising quality or compliance. Leverage technology , including Labeling Management Systems, to improve labeling accuracy, data integrity, and cross-functional visibility. Champion best practices , developing Standard Operating Procedures (SOPs), work instructions, and training materials to ensure quality and compliance in all labeling activities. Basic Qualifications: Doctorate degree and 3 years of Pharmaceutical, Regulatory, or Quality Management experience OR Master's degree and 8 to 12 years of Pharmaceutical, Regulatory, or Quality Management experience OR Bachelor's degree and 12 to 14 years of Pharmaceutical, Regulatory, or Quality Management experience OR Diploma and 16 to 18 years of Pharmaceutical, Regulatory, or Quality Management experience. Preferred Qualifications: Proficiency in project management and vendor oversight, ideally within a global or matrixed organization. Experience with electronic Labeling Management Systems , such as Veeva Vault or similar tools. Strong knowledge of global regulatory labeling requirements , including US, EU , and emerging markets . Strong analytical skills for troubleshooting, process mapping, and implementing continuous improvement initiatives in labeling and compliance processes. Soft Skills: Excellent leadership , communication, and interpersonal skills. Ability to prioritize tasks in a fast-paced, dynamic environment. Problem-solving and decision-making skills with a focus on compliance and operational excellence. Ability to collaborate across multiple teams , aligning on global strategies and deliverables. Strong attention to detail and commitment to quality in all aspects of work. What We Offer: Opportunity to lead and shape global labeling compliance initiatives in a highly dynamic and innovative environment. A collaborative, cross-functional working atmosphere that fosters professional growth and development. Competitive compensation, benefits, and flexibility for remote or hybrid work. The chance to make an impact in the biotech industry , ensuring compliance while driving continuous improvements in labeling and regulatory processes.

Working in close collaboration with cross-functional teamssuch as Regulatory Affairs, Quality, Clinical, Operations, and Supply Chainyou will ensure that labeling processes, documentation, and systems remain accurate and inspection-ready. You will act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives and upholding high-quality standards. Key Responsibilities: Global Labeling Coordinate end-to-end labeling changes (including updates, reviews, and approvals) ensuring alignment with regional and international regulations. Maintain and refine labeling templates, SOPs, and related documentation to sustain consistency and compliance. Cross-Functional Collaboration Collaborate with local, regional, and global teamsincluding Regulatory Affairs, Quality, and Supply Chainto identify labeling requirements, address challenges, and meet project milestones. Communicate clearly and proactively with relevant stakeholders, providing expertise on labeling processes and compliance requirements. Planning & Execution Develop detailed project plans and timelines for labeling initiatives, ensuring completion within defined schedules. Monitor progress, identify potential risks, and implement corrective actions to keep projects on track. Process Improvement & Compliance Identify opportunities to streamline labeling workflows and enhance efficiency, driving continuous improvement within the labeling function. Support inspection readiness by maintaining up-to-date records, robust quality checks, and accurate documentation for audit purposes. Technical & Operational Support Perform critical reviews of artwork, translations, and labeling content to verify accuracy and adherence to regulatory standards. Troubleshoot issues related to labeling systems, ensuring timely resolution and minimal operational disruption. Mentoring & Knowledge Sharing Provide guidance and training to junior team members and new hires on labeling standards, tools, and best practices. Foster a culture of knowledge-sharing and continuous learning to build expertise within the team. Qualifications Basic Qualifications: Doctorate degree OR Master's degree and 4 to 6 years of directly related experience OR Bachelor's degree and 6 to 8 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Required Qualifications: Knowledge of: Labeling Management Systems (e.g., Veeva Vault) and related document management tools. Strong knowledge of: global regulatory labeling requirements, especially for pharmaceuticals or biologics. Proven track record in: project planning and execution, with strong organizational and problem-solving skills. Excellent communication skills, with the ability to collaborate effectively in a global, cross-functional environment. Experience in: continuous improvement methods to enhance labeling processes and efficiency. Soft Skills: Excellent written/oral communication skills and attention to detail. Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment. Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results.

Devops SME Experience8+ Years Relevant Experience5+ Years Interview Mode: Virtual Work Mode: Remote Immediate Joiners PreferredShift Timings: 2 PM TO 11 PM Description: DevOps Subject Matter Expert (SME) with deep expertise in process and tool chain assessments to support the Veeva Development Cloud (Quality, Regulatory, Safety). The SME will lead the discovery phase from offshore, providing recommendations on DevOps processes, tools, and compliance alignment, and then support the execution phase to implement the roadmap. 8+ years of experience in DevOps, CI/CD, and automation frameworks. Hands-on expertise with tool chains such as GitHub/GitLab, Jenkins, Azure DevOps, Terraform, Kubernetes, Docker, and monitoring solutions. Experience in life sciences / pharma industry with exposure to Veeva Vault (Quality, Regulatory, Safety). ¢ Strong knowledge of compliance-driven DevOps practices (GxP, validation, audit readiness). ¢ Proven track record in process assessments, toolchain recommendations, and roadmap definition. Strong communication and stakeholder management skills to lead from offshore.

Your responsibilities will include supporting regulatory teams by ensuring seamless data entry, document management, and workflow automation. You will assist in the preparation, submission, and tracking of regulatory filings through Veeva RIM. It is essential to stay updated on Veeva Vault enhancements and industry trends. Additionally, you will assist with data migration and integration tasks and document processes and procedures for Veeva Vault RIM implementations. Generating reports and dashboards for regulatory performance tracking and compliance monitoring will also be part of your role. Building and maintaining good working relationships with relevant RA, non-RA stakeholders, and Health Authorities is crucial. You may also support the creation and maintenance of relevant training materials, work instructions, and SOPs, ensuring documentation is archived appropriately. Alternatively, you will support initiatives to improve and harmonize business processes in the area of ROPS and ensure updated processes are followed. Timely implementation of new or updated business processes on local and global levels will be coordinated by you, along with providing essential reports and information to enable informed decisions by internal stakeholders. Monitoring and ensuring the application of RA business intelligence to internal processes and systems in a timely manner is key. Furthermore, you will play a role in onboarding new associates into the organization and their tasks. In terms of essential requirements for this role, you should have a University or College Degree in any field or life science with relevant industry experience or a comparable degree. A minimum of 3 years of work experience in RIMS is required, along with good knowledge of Regulatory Affairs processes. Knowledge of Regulatory guidelines would be a plus. The ability to work under pressure, demonstrate initiative and flexibility, attention to detail, quality focus, team spirit, and embracing diversity of cultures and personalities are important characteristics. The desired skills for this position include proficiency in Veeva Vault, documentation management, and operational excellence. Sandoz is a leader in the Generic and Biosimilar medicines sector, providing over 900 million patient treatments across 100+ countries in 2024. With a commitment to shaping the future of Sandoz and expanding access to low-cost, high-quality medicines sustainably, the organization is investing in new development capabilities, production sites, acquisitions, and partnerships. The collaborative culture at Sandoz, driven by talented and ambitious colleagues, offers impactful, flexible-hybrid careers where diversity is welcomed, personal growth is supported, and a commitment to diversity and inclusion is hard-coded. If you are looking to be part of an inclusive work environment and contribute to diverse teams serving patients and communities, Sandoz welcomes you to join their team.,

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ensure consistency and scientific accuracy across deliverables. Experience with post-approval changes, tech transfers, and product lifecycle management will also be valuable in this role. In addition to primary skills, deep understanding of CMC regulatory requirements for biologics/biosimilars and experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics are secondary skills required for this position. Ideally, you should possess a minimum of 8 years of experience in CMC-Biologics along with a Master's degree in pharmaceutical sciences or other life sciences. Your ability to work independently, manage multiple priorities in a fast-paced consulting environment, and attention to detail are crucial for success in this role. Experience with RIMS/Veeva Vault for submission management and regulatory compliance is preferred. At Syneos Health, we are dedicated to developing our employees through career progression, supportive line management, training programs, and a total rewards program. Our Total Self culture fosters an environment where authenticity is encouraged, and diversity of thoughts and perspectives are valued. Join us in our mission to accelerate the delivery of therapies and change lives. Learn more about Syneos Health and the impactful work we do across 110 countries with 29,000 employees.,

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process, while ensuring compliance with regulatory regulations and guidance. The ideal candidate will have a strong background in system analysis and data science/AI in a regulated industry. Roles & Responsibilities: Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements. Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices. Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives. Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates. Required Knowledge and Skills: Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors. 5+ years" experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies. Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner. Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction. Familiarity with GxP requirements and systems validation. Life Sciences, Biotech, or pharmaceutical industry experience. Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault. Familiarity with global regulatory processes and standards. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. Basic Education and Experience: Bachelors degree and 2 years of directly related experience. Associates degree and 6 years of directly related experience. High school diploma/GED and 8 years of directly related experience. Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP. 5+ years experience in data management, machine learning, or related fields.,

Job responsibilities • Coordinates all key project meetings, phone calls, meeting rooms, etc. • Works with business stakeholders and vendors to finalize and get signoff on detailed scope of the project in line with the high level scope set forth in any Statements of Work (SoW) & project charters • Develops and gains signoff on the Project Strategy document, the plan of plans”, including, but not limited to, the communications plan, project team structure, recurring meeting (including steering) frequency, etc. • Develops project timeline / schedule using Microsoft Project, following all STS standards, working with the appropriate STS teams (e.g. Application Engineering, Digital & Business Technology Innovation, Infrastructure, Security, etc.), vendor teams, and business teams • Ensures all required deliverables as set forth in the STS RACI are included in the overall project schedule • As necessary for applicable projects, collaborates with the STS Validation Manager to ensure the system’s validation needs are assessed and defined • Prepares for, and conducts, project kickoff presentation • Begins preparations for Service Readiness Planning (handoffs to Production Support) at the onset of the project • Manages overall scope of projects as defined in the project charter, including the scope, schedule, financials, etc. of any project-related SoWs • Manages overall project communications, including communications to executive stakeholders, STS colleagues, vendors, business stakeholders, and clients as needed • Maintains issues & risks logs, ensuring issues & risks are categorized and prioritized appropriately, working with project stakeholders on risk mitigation strategies and action plans for issues, and escalating / raising at appropriate times • Manages the project schedule, baselining it and getting sign-off on it when scope is finalized, and always managing actuals vs. forecast vs. baseline • Conducts regular (e.g. weekly), action-oriented, project status meetings with all key project stakeholders • As dictated by the scope of different projects, works in close collaboration with vendor resources, multiple business units, and all STS teams to ensure the project is getting executed and will deliver the baselined scope within budget and schedule • Ensures all key deliverables are being produced, stored in the appropriate repository, and when applicable, signed-off on • Prepares weekly status reports and monthly / bi-monthly steering committee presentations • In coordination with Finance, ensures purchase orders are closed • Ensures all project deliverables are housed in the project document repository • Manages all activities required for production cutover including a smooth handoff to Production Support and the associated decommissioning of any legacy systems / contracts • Obtains business acceptance of newly released production systems • In coordination with Finance, setup POs, track invoices, track actual / committed spend / accruals, etc. • Ensures cross-functional resources assigned to tasks for a given project are executing those tasks Job Description What we’re looking for • Bachelor’s Degree, preferably with a technical concentration (e.g. Computer Science, etc) • Relevant Pharmaceutical / CRO industry experience • Ability to operate with limited oversight and needs to command the respect of a broad range of business and technology stakeholders. • Considered an expert at risk mitigation, being able to not just develop mitigation plans for already known risks, but continually “peeling the onion” to find the risks in the project that have not yet been identified. • Effective written and verbal communication skills • Proficient with Microsoft Project and common Microsoft Office applications (e.g. Excel, Power Point, Word, One Note)• Past IT experience in other, hands-on capacities (e.g. developer, database administrator, etc.) • Experience working with Sharepoint (or similar) project workspaces / document repositories • Experience managing Commercial Off the Shelf (COTS) and / or Software as a Service (SaaS) projects, including integrations into and out of these systems, data migrations, etc • Technically skilled Project Management professional comfortable managing the tasks of application engineers, database administrators, data architects, infrastructure, security, and other technical functions • Must have experience working with local and virtual teams. • Must have experience managing mixed internal/vendor and vendor-only project delivery teams • Preferred – Systems Integration Consulting / Management Consulting experience • Preferred - PMP Certification • Preferred - Agile / Scrum system development lifecycle experience

Are you an expert in content insights with experience in Veeva Vault and Power BI Novo Nordisk is seeking a Project Manager-Content Insights to join the Commercial GBS department. If you are ready for a new challenge, read on and apply today for a life-changing career. As a Project Manager for Content analysis, you will act as an expert within analytics of content usage across digital channels. Your responsibilities include interpreting data, reporting on important KPIs, and assessing content performance for global and local teams. You will drive a data-driven approach in the internal content production hub, ensuring actionable insights that can drive business change. Your role involves collaborating with global and local teams to enhance content use and re-use. Key responsibilities include: - Establishing a high-quality reporting foundation with a deep understanding of digital content creation, reuse, localization, and usage in Veeva Promo mats. - Analyzing content module data, generating insights, and effectively communicating findings to a broad audience. - Showcasing expertise in data methodology, availability, and validity. - Creating dashboards overview and providing advisory on content usage to colleagues and stakeholders. - Demonstrating a commercial mindset and basic understanding of business objectives to enhance the digital experience through content excellence. Qualifications for this role include: - Degree or above in a relevant area. - Over 7 years of relevant pharma work experience. - Expertise in VVPM with a focus on content insights and analytics. - Hands-on experience in front-end visualization tools like Power BI or QlikSense. - Strong storytelling skills in dashboard building. - Good presentation skills and commercial understanding of KPIs. - Ability to analyze data and offer evidence-based recommendations. - Proactive, solution-oriented, with excellent time-management skills. - Strong interpersonal and communication skills. The Commercial GBS department at Novo Nordisk is responsible for creating insights for product launches, market intelligence, customer engagement planning, and global brand strategy. Located at the headquarters, this dynamic department plays a crucial role in driving the success of the business. Novo Nordisk is a leading global healthcare company committed to defeating serious chronic diseases. With a strong legacy in diabetes, we impact over 40 million patient lives daily. Join our team of over 63,000 employees worldwide as we work together toward something bigger than ourselves. Apply now and be part of our life-changing mission. To submit your application, please upload your CV online by the deadline of 30th June 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants.,

Ready to build the future with AI At Genpact, we don't just keep up with technology-we set the pace. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges. If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what's possible, this is your moment. Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook. Inviting applications for the role ofConsultant, Veeva CRM Responsibilities Develop tailored Veeva CRM solutions that address specific business needs and align with organizational goals. . Work closely with business analysts, stakeholders, and other technical teams to gather requirements and translate them into technical specifications. . Oversee the implementation and configuration of Veeva CRM, ensuring a seamless deployment in line with industry best practices. . Provide expert guidance on data management, system integrations, and any necessary system upgrades. . Create and maintain comprehensive documentation of system architecture, processes, and configurations for future reference. . Support regulatory compliance initiatives, ensuring adherence to data governance policies. . Co-ordinate with business and technical teams for Veeva CRM and integration . Experience in working with the Life Science industry and understanding of Veeva CRM applications . POC from the project team for customer . Ability to address salesforce platform specific questions and work with the integration team to support the build integrations, Veeva (CRM) integrations, and API client integrations. . To be able to work on current problems while thinking of future solutions. . Ability to drive creative and efficient use of technology and thrive in a team environment. . Highly skilled technologist who can strategize the full lifecycle of product production - from conception through to release. . You have strong communication skills and can translate technical concepts to non-technical terms and partners. . Strong knowledge of Veeva CRM and Veeva Vault Promomats . Qualifications we seek in you! Minimum Qualifications / Skills . Extensive experience in CRM architecture, implementation, and integrations, with a focus on Veeva CRM. . Strong knowledge of Veeva CRM architecture and related integrations. . Solid understanding of data management, compliance, and governance standards in the pharmaceutical industry. . Excellent communication skills to interact effectively with business stakeholders, technical teams, and other organizational levels. Preferred Qualifications/ Skills BTech/MCA Veeva CRM Certified Veeva Vault Certified Why join Genpact . Lead AI-first transformation - Build and scale AI solutions that redefine industries . Make an impact - Drive change for global enterprises and solve business challenges that matter . Accelerate your career-Gain hands-on experience, world-class training, mentorship, and AI certifications to advance your skills . Grow with the best - Learn from top engineers, data scientists, and AI experts in a dynamic, fast-moving workplace . Committed to ethical AI - Work in an environment where governance, transparency, and security are at the core of everything we build . Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up. Let's build tomorrow together. Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a %27starter kit,%27 paying to apply, or purchasing equipment or training.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 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 world s 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 tasks of building dossiers and Coordination for LCM activities accordance with ICH and Global Requirements and 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 scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example Build regulatory submission strategy, author regulatory documents, and health authority packages etc. What are we looking for Life Sciences Regulatory Services Ability to manage multiple stakeholders Ability to meet deadlines Ability to perform under pressure Ability to work well in a team Agility for quick learning Veeva Vault and Regulatory Life Sciences Requirements Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Hi, We are hiring Veeva Developer With Promomats Exp Please share us the updated profile to mahesh.mattaparthi@cerebra-consulting.com Position: Veeva Developer With Promomats Exp Location: Noida,Chennai Job Type: C2H Experience: 5+ Years Notice Period: 15 Days /Immediate joiners preferred. Job Description: Overall 5+ years of exp Veeva Developer Promomats exp

As a Senior Regulatory Associate (CMC) at Syneos Health, you will play a crucial role in ensuring regulatory compliance by leveraging your practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks such as FDA and EMA. Your responsibilities will include preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, renewals, annual reports, and RTQs. In this dynamic role, you will be expected to support change control assessment and impact assessments for global markets, as well as execute day-to-day tasks according to client processes and SOPs to build high-quality global CMC dossiers. Additionally, you will be involved in training and mentoring team members as needed based on project requirements. Your role will also entail liaising with cross-functional teams including Quality, Manufacturing, Analytical, etc., to gather necessary technical data and ensure regulatory consistency for global submissions. You should possess excellent written and verbal communication skills and be open to working in Cross-Cultural/Virtual teams, attending client meetings as required with relevant inputs. To qualify for this position, you should have a minimum of 4 years of experience in preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, preferably with a Masters degree in pharmaceutical sciences or other life sciences. The ability to work independently, manage multiple priorities in a fast-paced consulting environment, and experience with RIMS/Veeva Vault for submission management are essential qualifications for this role. Syneos Health is committed to developing its employees through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program. Join us in our mission to accelerate the delivery of therapies and make a difference in the lives of patients worldwide. Find out more about Syneos Health and our impactful work at http://www.syneoshealth.com.,

Ready to build the future with AI At Genpact, we don&rsquot just keep up with technology we set the pace. AI and digital innovation are redefining industries, and we&rsquore leading the charge. Genpact&rsquos AI Gigafactory, our industry-first accelerator, is an example of how we&rsquore scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges. If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what&rsquos possible, this is your moment. Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook. Inviting applications for the role of Principal Consultant, Veeva CRM Responsibilities Develop tailored Veeva CRM solutions that address specific business needs and align with organizational goals. . Work closely with business analysts, stakeholders, and other technical teams to gather requirements and translate them into technical specifications. . Oversee the implementation and configuration of Veeva CRM, ensuring a seamless deployment in line with industry best practices. . Provide expert guidance on data management, system integrations, and any necessary system upgrades. . Create and maintain comprehensive documentation of system architecture, processes, and configurations for future reference. . Support regulatory compliance initiatives, ensuring adherence to data governance policies. . Co-ordinate with business and technical teams for Veeva CRM and integration . Experience in working with the Life Science industry and understanding of Veeva CRM applications . POC from the project team for customer . Ability to address salesforce platform specific questions and work with the integration team to support the build integrations, Veeva (CRM) integrations, and API client integrations. . To be able to work on current problems while thinking of future solutions. . Ability to drive creative and efficient use of technology and thrive in a team environment. . Highly skilled technologist who can strategize the full lifecycle of product production from conception through to release. . You have strong communication skills and can translate technical concepts to non-technical terms and partners. . Strong knowledge of Veeva CRM and Veeva Vault Promomats . Qualifications we seek in you! Minimum Qualifications / Skills . Extensive experience in CRM architecture, implementation, and integrations, with a focus on Veeva CRM. . Strong knowledge of Veeva CRM architecture and related integrations. . Solid understanding of data management, compliance, and governance standards in the pharmaceutical industry. . Excellent communication skills to interact effectively with business stakeholders, technical teams, and other organizational levels. Preferred Qualifications/ Skills BTech/MCA Veeva CRM Certified Veeva Vault Certified Why join Genpact . Lead AI-first transformation - Build and scale AI solutions that redefine industries . Make an impact - Drive change for global enterprises and solve business challenges that matter . Accelerate your career Gain hands-on experience, world-class training, mentorship, and AI certifications to advance your skills . Grow with the best - Learn from top engineers, data scientists, and AI experts in a dynamic, fast-moving workplace . Committed to ethical AI - Work in an environment where governance, transparency, and security are at the core of everything we build . Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up. Let&rsquos build tomorrow together. Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a %27starter kit,%27 paying to apply, or purchasing equipment or training. purchasing equipment or training .

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

Job title : Data Product Analyst Quality and HSE Location : Hyderabad About Us Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in peoples hands by making self-care as simple as it should be . For half a billion consumers worldwide and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. About the job: Role Overview: The Data Product Analyst, part of the global Digital Data & Analytics team, is responsible for enabling data-driven decision-making across the Quality and HSE domains. This role focuses on designing semantic layers in Snowflake, developing insights through Power BI dashboards (KPIs) and ad-hoc reporting, and ensuring the integrity and quality of data integration across multiple systems. The analyst will act as a key liaison between business functions, data engineers, and architects to bridge business insights with enterprise data solutions. Key Responsibilities: Stakeholder Engagement: Seamlessly collaborate with the Quality and HSE Business & Digital functional team to understand business processes, data sources, and reporting requirements. Scope management and prioritization: Manage multiple scope items simultaneously, being able to accurately estimate efforts and set up priorities according to business value. Semantic Layer Design: Design and implement semantic layers in Snowflake, integrating data from our multiple enterprise systems to support scalable analytics solutions. Lead AI Use Cases: Lead the creation of AI use in the business domain involving required DA /DE / AI /ML teams. Ad-Hoc Reporting: Develop ad-hoc reports in Snowflake / Power BI by consolidating data from multiple domain systems and third-party tools, ensuring accuracy and business relevance. Dashboard Development: Build and maintain domain-specific dashboards using Power BI, focusing on KPIs and operational metrics that drive continuous improvement in quality and HSE processes. Specifications & Documentation: Write clear functional and technical specifications for new datasets to be added to the data foundation, collaborating closely with data engineers and architects. Testing & Validation: Conduct System Integration Testing (SIT) and support User Acceptance Testing (UAT) to validate data flows, transformations, and dashboard outputs for global solutions. Data Governance: Support the deployment of data governance practices, ensuring data quality, lineage, and compliance within the M&S domain. Required Skills & Qualifications: Business understanding: Deep understanding of Quality and HSE business processes, including Deviation Management, Change Control, CAPA, and Audit Management for Quality; and Incident Management, Risk Assessment, Waste and Emissions Management, and Environmental Compliance Monitoring for HSE. Functional KPI knowledge: Familiarity with key Quality and HSE KPIs. Data Architecture and Data Modeling: Proven experience in designing data models following best practices. Understanding of ETL/ELT processes and orchestration tools Technical expertise: Strong functional and technical knowledge of the following technologies: SAP QM (Quality Management) SAP HSE Veeva vault Veeva QMS Understanding of SAP MM and SAP Material Master data is recommended SAP Analytics / SAP BW in quality and HSE modules expertise is strongly recommended. Power BI: Expert-level experience in developing interactive dashboards and reports in Power BI, with a deep understanding of DAX and data modeling. Snowflake: Proficient in querying and working with Snowflake, especially for designing semantic layers and integrating diverse data sources. Data Integration Collaboration: Demonstrated ability to work with data engineers and data architects to translate business requirements into scalable data pipelines and models. Testing & Quality Assurance : Experience conducting system integration testing (SIT) and supporting UAT for data and analytics solutions. About you: Education : Bachelor’s or master’s degree in business, Engineering, Computer Science, Data Science, or a related field. Experience: 10+ years in data and analytics for Quality and HSE roles. Soft and Behavioral Skills: Team Collaboration: Proven ability to work with multiple teams to drive alignment and results. Cultural Sensitivity: Experience working with multicultural, global teams. Service-Oriented: Flexible, positive team player with a strong service orientation. Communication: Excellent written and verbal communication skills. Initiative: Self-motivated, proactive, and takes initiative. Problem Solving: Strong problem-solving and critical thinking skills.