129 Veeva Jobs

Mandatory Keywords - Veeva CRM, Salesforce, Veeva Vault SFA Veeva: Developer for Salesforce applications Responsible for the Development activities for enhancements and projects salesforce applications Interact with business to gather requirements and requests communicate and coordinate business stakeholders Key Responsibilities: Perform configuration customization and impact analysis The candidate will be responsible for delivering in a timely and accurate fashion solutions using Veeva Vault Platform Perform Code Review and Code Optimization Ensure enhancements and projects delivered with quality on time Build strong working relationships with Onsite offshore business teams and external vendors Being able to escalate issues to internal developers external vendors or to infrastructure providers Present weekly monthly metrics to respective stakeholders

Description. Sr Regulatory Associate (EU mkt exp, Module 1). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Minimum 3 years of experience in the EU regulatory environment.. Basic understanding of regulatory procedure, including authoring of Module 1 documents, cover letters, and application forms.. Strong knowledge of regulatory systems such as Veeva Vault, DMS and RIMS. Responsibilities. Essential Functions For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:. Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.. Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.. Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.. Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.. Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.. Attends client meetings as needed and builds client relationship in support of projects and deliverables.. Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.. Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.. Assists in training and mentoring of team members depending upon project requirements.. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.. Qualifications. BS/BA degree or equivalent practical experience.. Experience in a work-related area preferred.. Excellent interpersonal / communication skills.. Advanced skills in Microsoft Office Applications.. Strong analytical skills.. Ability to work independently and to understand and carry out detailed instructions.. Ability to interact with staff from multiple departments.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Description. Regulatory Consultant (Sterile Experience). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Experience in regulatory submissions for sterile drug products, including aseptic and terminal sterilization processes.. Preparation and review of Module 3.2.P sections related to sterile manufacturing, microbial control, and container closure systems.. Post approval variation experience is mandatory for EU market.. Familiarity with EU Annex 1 requirements and its application in variation, renewal submissions.. Supports in preparation and peer review of regulatory submissions including variations, renewals, and responses to queries.. Handling post-approval changes related to sterile facilities, cleanroom classification, sterilization methods, and equipment upgrades.. Preparation of regulatory assessments and submission strategies specific to sterile dosage forms.. Reviews of media fill protocols, filter validation data, sterility assurance, and cleaning validation documentation for submission readiness.. Provides regulatory support during inspections and audits related to sterile manufacturing.. Change control assessments and preparation of regulatory impact summaries.. Day-to-day execution of tasks in accordance with client SOPs and regulatory standards for high-quality global CMC dossiers.. Collaboration with cross-functional teams including QA, QC (microbiology), validation, technical, analytical, and site functions for data collection and dossier preparation.. Secondary. Acts as a point of contact for coordination of documentation across functional teams to meet submission timelines.. Effective communication through email and calls with internal and client stakeholders for updates and clarifications.. Supports and mentors junior team members depending on project needs.. Hands-on experience with RIMS/Veeva Vault.. Open to working in cross-cultural and virtual team settings.. Qualifications. Minimum 6 years of experience required for regulatory submissions for sterile drug products with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Qualifications. Experience:. At least 2 years Clinical Trial EDC (preferably EDC systems like Veeva, RAVE, or Oracle) and/or Reporting experience (preferably JReview, Spotfire, Jupyter Labs, SQL).. Technical Skills:. Familiarity with common troubleshooting tools and technologies (e.g., JIRA, Dynamics , etc.).. Familiarity with Microsoft Office products (e.g. Office, Excel, PowerPoint, Dynamics). Nice to have -. ? Understanding of web technologies and web services (e.g., RESTful APIs, SOAP, etc.).. ? Experience with understanding database technologies (Java, Python, SQL, for example) and troubleshooting issues related to cloud-based software systems.. Soft Skills:. Excellent verbal and written communication skills with the ability to explain technical concepts to non-technical audiences and vice versa.. Strong problem-solving skills. Customer-centric mindset with a passion for helping clients resolve issues.. Ability to multitask, prioritize, and manage a high volume of requests.. Education:. Bachelor's degree in Computer Science, Information Technology, Life Sciences, or related field (preferred but not required).. Show more Show less

Description. Mgr, Regulatory Consulting (Portfolio Management -EU). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Works independently to formulate and lead regulatory strategy for a portfolio of products. Manages end-to-end regulatory lifecycle activities such as new MAAs, renewals, RA/CMC variations, HAQs, annual reports, xEVMPD activities, site renewals/GMP clearances, periodic safety reports and safety updates for global markets with extensive experience in EU procedural submissions.. Acts as a representative of the regulatory department with other departments. Manages liaison with cross functional teams and acts as the point of contact for client counterparts. Provides strategic and operational advice to clients.. Acts as a key point of contact for client and regulatory authorities. Arranges, leads, and reports on client and regulatory agency meetings.. Responsible for day-to-day management of project teams and projects. Provides regulatory advice to junior team members.. Participates in quality improvement efforts to increase overall operational efficiency. Lead process improvement initiatives for client projects.. Develops solutions to complex problems. Acts as a resource for technical knowledge.. Robust risk identification, mitigation and escalation. Provide resolution for all kind of risks.. Appreciable experience in RIMS/DMS preferably Veeva.. Provides internal training in appropriate areas of expertise to junior team members and other departments.. Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.. Monitors personal utilization and utilization of direct reports.. Supports business development, including generation of repeat business from existing clients and proposal development.. Conducts regulatory research on projects as needed.. Contributes to the building of regulatory systems and infrastructure needed for GRAS.. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.. Other Responsibilities:. Performs other work-related duties as assigned.. Qualification Requirements. Master’s degree in pharmaceutical sciences. Above 10 years of demonstrated experience in end-to-end portfolio management for drug products with Subject matter expertise in managing EU markets. Comprehensive regulatory knowledge and understanding of pharmaceutical product development.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management and budgeting skills.. Good people management, project management, problem-solving, and decision-making skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Summary. Responsible for leadership of major assignments and client relationships. Responsible for organizing and managing project teams and for the quality and timeliness of assignments. Provides advice and assistance to clients and other associates in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies, Standard Operating Procedures, and governmental regulations. Contributes to business development for regulatory functions.. Show more Show less

Job title: Global stability management specialist. Location: Hyderabad. % of travel expected: As per business needs. Job type: Permanent. About The Job. Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.. Main Responsibilities. Attach supplementary materials that support the report's content. Check the report is consistent in appearance and adheres to style guidelines. Evaluate and adjust user access rights to system documentation to ensure security and validity. Launch and manage the review workflow in CMS. Receive report approval, final reviewer agreement and initiate approval workflow in CMS/ Veeva. Regularly update and maintain records of document ownership and ensure compliance with access protocols. Review the report to correct any language or typographical errors. About You. Experience: Experience in pharmaceutical quality. Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments. Technical skills: LIMS, Word, Excel, Power Point; Experience in a Pharmaceutical GxP environment, preferred experience in stability management or activities. Education: Bachelor's degree in stability science, biology, chemistry, or a related field. Advanced degree preferred. Languages: Excellent English communication and writing, French or other Languages in addition preferred. null. Show more Show less

Description. Sr Regulatory Consultant (Biologics/Biosimilars). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Primary Skills required. Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses.. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications.. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH).. Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development.. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables.. Experience with post-approval changes, tech transfers, and product lifecycle management.. Excellent written communication, scientific writing, and document organization skills.. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars.. Secondary Skills Required. Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance.. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics.. Qualifications. Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Role & responsibilities Key Accountabilities: Good experience as a Data Engineer with Veeva and Clinical Data Management, Experience building data pipelines for various heterogenous data sources. Must have hands-on experience in Veeva and Clinical Data Management CDMS. Identifying, designing and implementing scalable data delivery pipelines and automating manual processes Building required infrastructure for optimal data extraction, transformation and loading of data using cloud technologies like AWS, Azure etc., Develop end to end processes on the enterprise level for use by the clinical data configuration specialist to prepare data extraction and transformations of raw data quickly and efficiently from various sources at the study level Coordinate with downstream users such as statistical programmers, SDTM programming, analytics, and clinical data programmers to ensure that outputs meet requirements of end users Experience creating ELT and ETL to ingest data into data warehouse and data lakes Experience creating reusable data pipelines for heterogenous data ingestions Manage and maintain pipelines and troubleshoot data in data lake or warehouse Provide visualization and analysis of data stored in data lake Define and track KPIs and provide continuous improvement Develop and maintain, tools, libraries, and reusable templates of data pipelines and standards for study level consumption by data configuration specialist Collaborate with various vendors and cross functional teams to build and align on data transfer specification and ensure a streamlined process of data integration Provide ad-hoc analysis and visualization as needed Ensure accurate delivery of data format and data frequency with quality deliverables per specification Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business. Collaborate with system architecture team in designing and developing data pipelines as per business needs Network with key business stakeholders on refining and enhancing the integration of structured and non-structured data. Provide expertise for structured and non-structured data ingestion Develop organizational knowledge of key data sources, systems and be a valuable resource to people in the company on how to best integrate data to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including assisting with the definition, build, and validation of application program interfaces (APIs), data streams, data staging to various systems for data extraction and integration Experience in creating data integrity and data quality checks for data ingestion Coordinates with data base builders, clinical data configuration specialists and data management (DM) programmers ensuring accuracy of data integration per SOPs Provide technical support / consultancy and end-user support, work with Information Technology (IT) in troubleshooting, reporting, and resolving system issues Develop and deliver training programs to internal and external team, ensure timely communication of new and/or revised data transfer specs Continuous Improvement/Continuous Development Efficiently prepare and process large datasets for various end users for downstream consumption Understand end to end requirements for stakeholders and contribute to process and conventions for clinical data ingestion and data transfer agreements Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations Ensure compliance with own Learning Curricula, corporate and/or GxP requirements Assists with quality review of above activities performed by a vendor, as needed Assess and enable clinical data visualization software in the data flows Performs other duties as assigned within timelines Performs clinical data engineering tasks according to applicable SOPs (standard operating procedures) and processes. Experience in data engineering, building data pipelines to manage heterogenous data ingestions or similar in data integration across multiple sources including collected data. Experience with Python/R/ RShiny, SQL, NoSQL Cloud experience (i.e. AWS, AZURE or GCP) Experience with GitLab, GitHub Experience with Jenkins, GitLab Experience deploying data pipelines in the cloud Experience with Apache Spark (databricks) Experience setting up and working with data warehouse, data lakes (eg: snowflake, Amazon RedShift etc.,) Experience setting up ELT and ETL Experience developing and maintaining data pipelines for large amounts of data efficiently Must understand database concepts. Knowledge of XML, JSON, APIs. Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively. Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Ability to work independently, take initiative and complete tasks to deadlines. Preferred candidate profile

Work Location: Pan India Experience: 8-12yrs Job Description: Perform configuration customization and impact analysis The candidate will be responsible for delivering in a timely and accurate fashion solutions using Veeva Vault Platform Perform Code Review and Code Optimization Ensure enhancements and projects delivered with quality on time Build strong working relationships with Onsite offshore business teams and external vendors Being able to escalate issues to internal developers external vendors or to infrastructure providers Thanks & Regards Suganya R suganya@spstaffing.in

Description Principal Clinical Programmer (Rave/Veeva) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Provides application administration and technical support as the subject matter expert on all core business packages, including but not limited to: Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supplemental packages such as migration mentoring/review, reporting tools, customfunctions, etc Utilizes primary development tools and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures, Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports Monitors applications proactively for workflow alerts, system errors, performance issues and troubleshoot programming deliverable defects, Performs system integrations activities, application updates, and user acceptance testing, Serves on project teams to coordinate and lead development activities for clinical programming projects Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner Balances multiple task assignments and communicates needs to supervisor to obtain needed resources, Participates in and provides input at project review and departmental review meetings Participates in bid defenses, Ensures high quality deliverables by providing senior review of program level/multi-study core deliveries for accuracy Attends sponsor audits and assists with in-progress audits, Reviews and provides input on study budgets, manages project level metrics, progress, and status, for large programs of studies from key sponsors Monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion Assists with the creation of change orders, Provides leadership, mentorship, training, guidance, and support to other department members based upon expertise in specific skill sets Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications and uses expanded technical skills to meet evolving project needs, Attends Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies, Provides leadership/oversight of five (5) to twenty (20) concurrent studies depending upon scope, similarity, program, and resourcing requirements This may include the oversight of other lead programmers and their associated studies, Manages project resources, proactively alerting management of delivery and resourcing needs, Assists with management of application vendors and serves as an initial escalation contact Monitors vendor service level agreements (SLAs) and reports metrics to upper management, Supervises the implementations of upgrades and new modules ofremotely hosted vendors, acquiring all documentation and storing in the relevant areas, Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc Contributes towards the update of standard operating procedures and work instructions in line with department and company process and policy As required, oversees program level clinical programming operations by providing supervision for a team of clinical programmers Responsibilities may include professional development performance appraisals, and employee advising for junior staff Assigns project work and reviews workload for all direct reports Manages staff development by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level Resolves conflicts/priorities at the program level prior to making any recommendations to management Advises on administrative policies and procedures, technical problems, priorities, and methods, Qualifications Bachelors degree, Masters degree preferred, In lieu of Bachelors degree, equivalent related education and experience, Minimum 8 years of experience in End-to-End clinical programming in Rave OR Veeva, with hands-on with EDC build, Study/DB Build, eCRF Build, Edit Checks programming, Migrations & PPC experience Strong Custom Functions programming experience with Rave EDC, Must have Lead experience, The ability to deal effectively with sponsors and internal customers at all levels, Excellent communication and interpersonal skills, both written and spoken, with an ability to inform, Demonstrated experience in managing multiple priorities in a highly dynamic environment Experience working in a matrix-structured environment is preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred, Ability to travel as necessary (up to 25%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job, Show more Show less

Design, build, Configure and support Veeva Vault based applications to meet business process and application requirements.Prepares communications and makes presentations on system enhancements and/or alternatives. Evaluates, optimizes, harmonizes, and standardizes existing systems. Create and update system documentation. Monitors quality standards and ensures failure-free operation. Considers compatibility of different systems. Solves a range of straightforward problems through knowledge and technical experience in own discipline with a moderate level of guidance. Analyzes information and possible solutions and makes independent judgments, decisions, and recommendations. Support the on-going regulatory compliance of the IT components for defined services. Review and approve regulatory system changes and documentation. Support periodic reviews, audits, security reviews of the entire system and compile related reports during operation phase. Support the qualification, validation, testing and documentation related to IT solutions delivery Understands how the team integrates withing teams and other teams to achieve overall objectives of the area and builds knowledge of the organization, processes, customers, and key business drivers. Understands how the team integrates withing teams and other teams to achieve overall objectives of the area and builds knowledge of the organization, processes, customers, and key business drivers. Working knowledge of Information security and best practices Who you are Experience in Configure and support Veeva Vault

Role & 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. Preferred candidate profile

Role & responsibilities Validation Engineer • Expertise in preparing end-to-end validation documentation including protocols and reports. Collaborates closely with the testing team to ensure execution aligns with requirements. • Should utilize a risk-based approach for validation/testing. Veeva tool Preferred candidate profile

Role & responsibilities Understand the project scope for QA, clarify the requirements prior to execution and deliver to execution plans. Develop and execute QA plans to meet the business objectives; adopt best practices and track KPIs/SLAs. Responsible for setting processes, documentation (Checklist) and quality assurance standards. Log defects against brand guidelines, themes, technical specifications, functionality verification with details, perform validation upon bug fix and track the defects towards closure. Communicate with the team and collaborate with other stakeholders on project requirements, deliverables, and challenges. Ensure compliance to defect tracking and management processes. Ensure trainings (technical and non-technical) are taken up and completed on time as per the timelines to meet business requirements. Must be able to prioritize tasks and ensure that schedules are adhered to with high quality assets being delivered. Must be a self-starter requiring minimal supervision for day-to day task management and project delivery. Preferred candidate profile Candidates should have worked in complex, agile production environments. Experience in QA & application testing, regression and user-acceptance testing. Should have good exposure working on digital assets like websites, videos, emailers (responsive), interactive detail aid. Good knowledge in implementing test scenarios and test processes. Experience in defect logging and management tools like JIRA and testing methodologies. Should have good understanding of the review process, and check-list creation. Good knowledge on VEEVA CRM digital products like edetail/idetail, is desirable. Experience with Web Accessibility standards, is desirable Experience in Cross browser testing, multi-OS, multi-device testing Experience with using plug-ins to minimize defects across digital assets High attention to details and a zero-defect mindset Must work with Team to build & implement an improvement mechanism to reduce defects internal and external QA must have a good understanding of the business requirement and how it fits into the overall project. Must have skills Production planning and team scheduling and Functional Requirements Checklists & Documentation and UI & Compatibility Testing Functional, Performance and UAT Testing and Quality Lifecycle management Good communication skills and able to coordinate with onsite/cross functional team. Hands-on experience in testing for print, web and mobile (responsive design) delivering high quality assurance. Experience on Litmus, Email on Acid, Pre-flight and Browserstack

Novo Nordisk Global Business Services (GBS) India Department – Commercial, GBS Are you an expert in content insightsDo you have experience in Veeva Vault and Power BIWe are looking for a Project Manager-Content Insights to join our team in the Commercial, GBS department at Novo Nordisk. If you are ready for a new challenge, read on and apply today for a life-changing career. The position As a Project Manager for Content analysis, you will act as an expert within analytics of content usage across digital channels by interpreting data, report to the business on important KPIs and the content performance for global and local teams. Drive and develop the agenda of a data-driven approach in Novo Nordisk internal content production hub by making sure insights are actionable and can drive change to the business. Your daily work-life will be as a sparring partner to relevant functions on primarily global but also local level on improving the content use and re-use. Ensuring a high-quality reporting foundation with deep understanding of digital content creation, reuse, localization and usage in Veeva Promo mats. Analyzing content module data, generating insights, and clearly communicate relevant findings to a broad audience to achieve maximum value of content across channels. Being a data specialist and showcasing deep knowledge about methodology, data availability and validity. Creating an overview of all dashboards and give advisory on content usage for colleagues and sharing dashboards to relevant stakeholders within the organization. Must have commercial mindset and basic understanding of business objectives. You are passionate about improving the digital experience through content excellence and ambitious about improving your skills within data analytics. Qualifications To be successful in this role, you should have the following qualifications: Degree or above in relevant area. Has +7 years of relevant pharma work experience. Candidate must be an expert within their field and have good understanding in VVPM particular within content insights and analytics of content usage. Substantial hands-on experience in front end visualization tools such as Power BI, QlikSense or similar. Sense of storytelling in building dashboards in tools such as QlikSense or PowerBI. Good presentation skills. Commercial understanding of KPIs. Ability to analyze data and provide evidence-based recommendations. Proactive and solution-oriented. Good time-management skills. Great interpersonal and communication skills. About the department The Commercial GBS department is responsible for creating insights to launch a product, market intelligence, forecasting, multichannel customer engagement planning, and global brand strategy and tactics. Our team consists of professionals in project management, brand management, brand communications, and life cycle management of products. Located at our headquarters, this fast-paced and dynamic department plays a crucial role in driving the success of our business.

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Experience in doing external data reconciliation 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 the 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 training 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 Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training 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 # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

What you will do We are seeking a detail-oriented and proactive Data Steward to support our pharmaceutical data governance initiatives. The ideal candidate will ensure the quality, consistency, integrity, and security of data across our systems, particularly within commercial, regulatory, R&D, and supply chain functions. You will play a key role in managing master data, supporting compliance (e.g., GxP, GDPR), and facilitating data-driven decision-making across the organization. Maintain and monitor master data for key domains (e.g., customer, product, vendor, material) Identify, investigate, and remediate data issues using profiling tools and dashboards. Define and enforce data definitions, naming conventions, and standard operating procedures Identify and correct data quality issues and anomalies using established data validation protocols. Implement data cleansing and enrichment processes Support company-wide data governance policies and frameworks. Ensure data complies with internal standards and external regulations (e.g., FDA, EMA, GDPR). Work closely with regulatory and quality teams to ensure alignment with compliance standards. Use statistical tools and modeling techniques to interpret trends, patterns, and correlations maintain data pipelines and manage data cleaning processes. Help identify data gaps and recommend solutions for improvement. ensure data accuracy, consistency, and integrity across systems Analyze large and complex datasets from internal and external sources (e.g., clinical trials, sales, market data). Serve as a liaison between business units (e.g., marketing, regulatory, supply chain) and IT. Collaborate with data owners and SMEs to define and enforce data standards. Provide training and support to end-users on data management best practices. Maintain the accuracy and completeness of master data in key systems (e.g., SAP, Veeva, Oracle). Support data migration and integration projects, ensuring clean and standardized data input. Assist in data extraction, reporting, and analytics to support business operations and decision-making. Generate periodic data quality reports and metrics Basic Qualifications: Degree in computer science, Data Management, or related field & engineering preferred with 2-5 years of software development experience 2-5 years of experience in a Data Steward, Data Analyst, or related role in the pharmaceutical industry Experience with data systems such as SAP, Veeva, Salesforce, Oracle, or Informatica is a plus. Excellent communication and collaboration skills. Preferred Qualifications: Experience with global data governance or enterprise data management initiative Knowledge of GxP, FDA/EMA guidelines, and industry-specific data compliance. Proficiency in SQL and at least one programming language (e.g., Python, R). Strong skills in data visualization tools (Power BI, Tableau, Qlik, etc.). Strong skills Postgres SQL /Mongo DB SQL database, vector database for large language models, Databricks or RDS, S3 Buckets Excellent communication skills, with the ability to present complex data in a simple, understandable way Good to Have Skills Postgres SQL /Mongo DB SQL database, vector database for large language models, Databricks or RDS, S3 Buckets design patterns, data structures, data modelling, data algorithms Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, remote teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.

Position Summary This position is part of the technical leadership in data warehousing and Business Intelligence areas. Someone who can work on multiple project streams and clients for better business decision making especially in the area of Lifesciences/ Pharmaceutical domain. Job Responsibilities o Technology Leadership – Lead guide the team independently or with little support to design, implement deliver complex cloud data management and BI project assignments. o Technical portfolio – Expertise in a range of BI and data hosting technologies like the AWS stack (Redshift, EC2), Snowflake, Spark, Full Stack, Qlik, Tableau, Microstrategy o Project Management – Get accurate briefs from the Client and translate into tasks for team members with priorities and timeline plans. Must maintain high standards of quality and thoroughness. Should be able to monitor accuracy and quality of others' work. Ability to think in advance about potential risks and mitigation plans. o Logical Thinking – Able to think analytically, use a systematic and logical approach to analyze data, problems, and situations. Must be able to guide team members in analysis. o Handle Client Relationship, P&L – Manage client relationship and client expectations independently. Should be able to deliver results back to the Client independently. Should have excellent communication skills. Education BE/B.Tech Master of Computer Application Work Experience Minimum of 5 years of relevant experience in Pharma domain. TechnicalShould have 15 years of hands on experience in the following tools Must have working knowledge of toolsAtleast 2 of the following – Qlikview, QlikSense, Tableau, Microstrategy, Spotfire Aware of techniques such asUI design, Report modeling, performance tuning and regression testing Basic expertise with MS excel Advanced expertise with SQL FunctionalShould have experience in following concepts and technologies Specifics Pharma data sources like IMS, Veeva, Symphony, Cegedim etc. Business processes like alignment, market definition, segmentation, sales crediting, activity metrics calculation 0-2 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company1-3 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company3-5 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company3-5 years of relevant experience in a large/midsize IT services/Consulting/Analytics Company Behavioural Competencies Project Management Communication Attention to P&L Impact Teamwork & Leadership Motivation to Learn and Grow Lifescience Knowledge Ownership Cultural Fit Scale of resources managed Scale of revenues managed / delivered Problem solving Talent Management Capability Building / Thought Leadership Technical Competencies AWS KnowHow Formal Industry Certification AWS Certified Cloud Practitioner Snowflake Data Engineering Data Governance Data Modelling Data Operations (Service Management) Data Warehousing & Data Lake Databricks Dataiku Formal Industry Certification Informatica_Cloud Data Warehouse & Data Lake Modernization Master Data Management Patient Data Analytics Know How Pharma Commercial Data - US Pharma Commercial Data - EU

12+ years of IT Experience 4+ years in Veeva Vault in combination with any of below combined skills Must Have combinations of Specialized application expertise in or either (Atleast 3 combinations of any three below), Veeva CRM Suite, Veeva Vault RIM - Regulatory Information Management, Veeva Quality, Veeva LIMS - Lab information Management systems, Veeva Vault - Med Inquiry, Veeva Clinical Operations, Veeva Promo Mats Should have worked in Veeva LSH/ Health cloud environment for 3+ Years in Projects Able to demonstrate solutions/walkthrough with business stakeholders Should have hands on in Estimation / Presentation/Document preparation Veeva Vault Architecture experience Technical Expertise in Veeva Vault

QUALIFICATIONS Education: Advanced degree in Life Sciences, Pharmacy, or related field Experience: 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals. Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred). Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees. Skills: Proficiency in clinical trial design, statistical analysis, and regulatory writing. Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms. Global Regulatory Strategy & Submissions Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan drug designations, and accelerated approvals. Lead NDA/MAA submissions for US FDA, EMA, and other agencies, ensuring compliance with ICH guidelines and regional requirements. Oversee clinical trial applications (CTAs/INDs) and provide input on study design, endpoints, and risk mitigation. Team Leadership & Cross-Functional Collaboration Manage a global team of regulatory professionals, fostering expertise in biologics, ophthalmology, and metabolic disorders. Partner with R&D, Clinical Development, and CMC teams to align regulatory plans with development milestones. Compliance & Audit Management Ensure adherence to GCP, GMP, and 21 CFR Part 11 standards during regulatory inspections and audits. Maintain submission timelines using eCTD formats and electronic submission gateways Team & Project Management Mentor QA leaders across sites, fostering a culture of quality and accountability. Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies. Post-Marketing & Lifecycle Management Direct post-approval regulatory activities, including variations, renewals, and safety updates. Monitor evolving regulations (e.g., FDAs Novel Drug Approvals guidance) and implement proactive compliance measures.

Experience 4-8 Years of experience in specifications, design, develop and unit test and functionally validate clinical trial setup process edit check specifications and program or modify checks at study level within EDC SME (Subject Matter Expert) for all database related activities Familiar with custom functions within EDC system Prepare, test and implement postproduction changes as per study needs Work with leaders to resolve issues affecting the delivery of clinical trials Lead technology vendor oversight activities Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks

We are seeking a Clinical Programmer with expertise in JReview listings, dashboards, and visualizations to support clinical data review, safety monitoring, data validation and clinical data visualization, analysis, and reporting for clinical trials. Required Candidate profile 4+ Years of experience. MS SQL Server and R, R packages e.g., Tidyverse, ggplot2, dplyr, Pipeline creation, or Oracle, SAS, Python, Elluminate, BOXI, Spotfire, Tableau, Macros, RShiny, JReview, Plotly

5 years of experience working with Veeva CRM and Veeva Vault, including implementation, configuration, and support. In-depth knowledge of Veeva platform capabilities, including object configuration, workflow design, and data management. Strong analytical and problem-solving skills, with the ability to quickly diagnose and resolve technical issues. Excellent communication and interpersonal skills, with the ability to effectively collaborate with both technical and non-technical stakeholders. Experience working in regulated industries, such as pharmaceuticals or biotechnology, is preferred. Veeva certifications, such as Veeva CRM Administrator or Veeva Vault Administrator, are a plus. Familiarity with related technologies, such as Salesforce.com, is beneficial. Ability to work independently and manage multiple priorities in a fast-paced environment.

Sr Associate IS Analyst - Veeva Vault Release Engineer What you will do In this vital role in Amgen Veeva Release Management team and focuses primarily on change and release management, encompassing the planning, scheduling, and deployment of changes and releases across various Veeva Vault in Amgen. You will also provide essential support and expertise to key business users for smooth transition of the releases. Roles & Responsibilities: Support in development and implementation of the release management process for Amgen Veeva Vault platform. Manage release plans, including timelines, resources, and risk assessments. Collaborate with IT and business teams to facilitate smooth and efficient Veeva releases. Assess and plan for the impact of Veeva changes and releases on partners. Assists to develop and managing communication plans to engage Veeva partners and provide clear messaging. Support designing and delivery of training programs, offering ongoing support and coaching. Be part of change impact evaluations. Oversee planning, scheduling, and coordination of Veeva releases, ensuring alignment with change management strategies. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelors degree and 3 to 5 years of Computer Science, IT or related field experience OR Diploma and 7 to 9 years of Computer Science, IT or related field experience Functional Skills: Must-Have Skills: Experience with Veeva Vault Platform and Products, including Veeva configuration settings and custom builds. 4 - 5 years of experience working in global pharmaceutical Industry Experience in building configured and custom solutions on Veeva Vault Platform. Experience in managing systems, implementing and validating projects in GxP regulated environments. Extensive expertise in SDLC, including requirements, design, testing, data analysis, creating and managing change controls. Proficiency in programming languages such as Python, JavaScript etc. Strong understanding of software development methodologies, including Agile and Scrum. Excellent written and verbal communication skills Preferred Qualifications: Familiarity with Agile methodologies for change management. Experience with change management tools and software. Knowledge of industry-specific regulations and standard processes, particularly in Life Sciences or Pharmaceuticals. Strong solution design and problem-solving skills Strong understanding of technology, function, or platform Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications: Veeva Vault Platform Administrator or Equivalent Vault Certification (Must-Have) SAFe for Teams (Preferred) Soft Skills: Excellent analytical and solving skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.