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The role of Business Development in Mumbai, India involves various responsibilities to enhance partnerships and product offerings. You will be tasked with scouting new partners/products and recommending products for consideration by senior and executive leadership. Developing comprehensive business cases across different product categories for the US and Canadian markets will be a key focus, including Institutional, Retail, and OTC segments. Your responsibilities will also include creating presentation materials for team and leadership meetings, supporting deal closure activities, assisting in drafting non-binding term sheets, and participating in agreement negotiations. You will play a crucial role in conducting due diligence on new business development deals, collaborating with internal stakeholders such as Regulatory Affairs, Project Management, R&D, Commercial, and Quality departments. Additionally, this role requires frequent travel to conferences and partner meetings. You will support the Business Development team in budget planning and long-range forecasting while establishing a network of trusted global development and manufacturing partners. The ideal candidate should have a minimum of 5 years of experience in a pharmaceutical company, particularly in portfolio and/or business development functions. Strong communication skills, both verbal and written, are essential, along with the ability to engage with global companies effectively. Proficiency in financial modeling, utilization of IQVIA, and expertise in Microsoft Excel, PowerPoint, and Word are crucial for success in this role. An intermediate understanding of the pharmaceutical life cycle, Hatch Waxman Act, and regulatory aspects related to business development evaluations is desired. Join us in this dynamic role to drive strategic partnerships and contribute to the growth of the organization.,

As an Industry & Functional AI Decision Science Consultant within the Accenture Strategy & Consulting Global Network - Data & AI practice, you will have the opportunity to work on high-visibility projects with esteemed Pharma clients worldwide. You will collaborate with leaders in strategy, industry experts, and business intelligence professionals to shape innovative solutions leveraging emerging technologies. Your role will involve supporting the delivery of consulting projects, developing assets and methodologies, and working on a variety of projects such as Data Modeling, Data Engineering, Data Visualization, and Data Science. Additionally, you will be expected to acquire new skills that are applicable across different industry groups, support strategies and operating models, and make presentations to clients when necessary. We are seeking individuals with a Bachelor's or Master's degree in Statistics, Data Science, Applied Mathematics, Business Analytics, Computer Science, Information Systems, or a related quantitative field. The ideal candidate will have proven experience working on Life Sciences, Pharma, or Healthcare projects, with a solid understanding of Pharma datasets including commercial, clinical, Real World Evidence (RWE), and Electronic Medical Records (EMR). Proficiency in Statistical Models, Machine Learning, hypothesis testing, multivariate statistical analysis, and optimization is essential, along with hands-on experience in handling datasets like Komodo, RAVE, IQVIA, Truven, and Optum. Strong programming skills in languages such as R, Python, SQL, and Spark are required, as well as experience with cloud platforms like AWS, Azure, or Google Cloud for deploying language models. Familiarity with Data Visualization tools like Tableau, Power BI, Qlikview, or Spotfire is advantageous. In this role, you must possess excellent analytical and problem-solving skills, a data-driven mindset, proficiency in Excel, MS Word, PowerPoint, and strong communication, interpersonal, and presentation skills. Your ability to solve complex business problems, deliver client satisfaction, and build points of view on industry trends will be crucial to your success in this position. Join us in a culture committed to accelerating equality for all and engage in boundaryless collaboration across the organization.,

As a Life Science Business Analyst at FocalCXM, you will collaborate closely with stakeholders in commercial domains to gather and analyze requirements, with a particular focus on leveraging expertise in Veeva Vault Promomats. Your role will involve translating business needs into clear user stories and technical specifications, supporting project delivery, collaborating with cross-functional teams, assisting in testing and training, and maintaining thorough documentation to ensure successful implementation and user adoption. Key Responsibilities - Actively liaise with business stakeholders to understand and translate business needs into technical specifications. - Engage proactively with cross-functional teams to convert unstructured requirements into well-defined deliverables. - Analyze current business processes and recommend improvements to enhance operational efficiency and effectiveness. - Lead or support the implementation of new systems or modifications to existing systems, ensuring alignment with business goals. - Conduct data analysis to gather insights and support business decision-making. - Create comprehensive documentation and provide end-user training to facilitate system adoption. - Ensure adherence to corporate IT policies and compliance standards, including data security and internal audit requirements. - Manage multiple concurrent projects, ensuring timely delivery and stakeholder satisfaction. - Collaborate with other IT teams, business units, and external vendors to deliver integrated solutions. - Provide specialized focus on Veeva Vault Promomats, Veeva CRM, and Salesforce solutions in a Healthcare/Life Sciences context. Technical & Functional Expertise The ideal candidate for this role must possess advanced-level expertise in the following areas: - Veeva Vault Promomats - Salesforce (with emphasis on Healthcare Solutions) - Business requirements gathering and documentation - Process improvement and optimization - Functional system implementation and configuration - End-user support and training Additionally, the candidate should have broad experience in: - Integration solutions - Global Data Warehouse solutions - Master Data Management (MDM) solutions - IQVIA and Accuratics software used to enhance healthcare innovation and patient outcomes. Required Skills & Experience - Bachelor's degree in a relevant field - 5-7 years of experience in business systems analysis and/or software development - Strong understanding of business requirements and ability to translate them into scalable technical solutions - Excellent written and verbal communication skills - Ability to manage multiple projects simultaneously across different scales (small, medium, large) If you are a self-starter who thrives in a fast-paced environment, eager to lead, quick to learn, and ready to take ownership, FocalCXM offers a competitive salary and benefits package, opportunities for professional development and career growth, a supportive and collaborative work environment, flexible working hours with 5 days working, and lunch and snacks provided every Friday. Join us at FocalCXM and be a part of our innovative team driving solutions for the Life Sciences industry.,

Experienced analytics professional with prior Pharma commercial analytics experience in - Customer segmentation - Sales Force Effectiveness / Operations – Sizing, Alignment, call plan, technology platforms Advanced Excel/VBA, Python/R & SQL.

As an experienced Competitive Intelligence professional, your primary responsibilities will involve executing secondary CI projects and providing comprehensive summaries on competitor events across clinical, regulatory, and commercial domains. You will play a crucial role in supporting multiple projects related to competitor monitoring, including investor relations activities. Additionally, you will be tasked with developing and delivering periodic reports encompassing market landscape analyses, competitive landscape assessments, and CI news alerts. Collaboration with various stakeholder groups will be essential to ensure alignment on project objectives. The ideal candidate for this role should hold a master's degree in pharmaceuticals, life sciences, or management, or possess equivalent qualifications. You should have a solid background with 5-10 years of experience in competitive intelligence or similar roles within the pharmaceutical industry or consulting organizations. A thorough understanding of the pharmaceutical business landscape is crucial for success in this position. Your proficiency should extend to navigating pharmaceutical databases, with expertise in platforms such as Citeline, Trial Trove, IQVIA, Cortellis, Evaluate, DRG, Biomedtracker, and AlphaSense. Strong analytical skills, attention to detail, and the ability to think critically are essential attributes for this role. You should be capable of working independently while adhering to aligned strategies, as well as collaborating effectively within a global and diverse team environment. Excellent organizational skills, time management, and the ability to prioritize tasks in a fast-paced setting are vital. Leadership qualities, including demonstrated team management capabilities, will be advantageous in this role. Proficiency in written and verbal English communication is a must, along with adeptness in Microsoft applications like Excel, PowerPoint, and Word. Your language proficiency should be in English. If you meet these requirements and are ready to take on the challenges of competitive intelligence in the pharmaceutical sector, we invite you to apply for this exciting opportunity.,

The Strategy & Consulting Global Network Song Practice| Marketing Transformation | Life Science Marketing Manager Join our team of Strategy & Consulting Global Network Song who solve customer facing challenges at clients spanning sales, service and marketing to accelerate business change. Practice: Strategy & Consulting Global Network Song I Areas of Work:Digital Marketing, Creative Strategy, Brand Strategy, Campaign Management, Next Best Action Marketing, Mar-Tech Strategy, Customer Experience & Journey Development | Level:Manager| Location:Delhi, Mumbai, Bangalore, Gurgaon, Hyderabad | Years of Exp:8+ years Explore an Exciting Career at Accenture Are you passionate about scaling businesses using in-depth frameworks and techniques to solve customer facing challengesDo you want to design, build and implement strategies to enhance business performanceDoes working in an inclusive and collaborative environment spark your interest Then, this is the right place for you! Welcome to a host of exciting global opportunities within Accentures Strategy & Consulting Global Network Song practice. The Practice A Brief Sketch The Strategy & Consulting Global Network Song practice is aligned to the Global Network Song Practice of Accenture and works with clients across their marketing, sales and services functions. As part of the team, you will provide transformation services driven by key offerings like Living Marketing, Connected Commerce and Next-Generation Customer Care. These services help our clients become living businesses by optimizing their marketing, sales and customer service strategy, thereby driving cost reduction, revenue enhancement, customer satisfaction and impacting front end business metrics in a positive manner. The Life Sciences Marketing Senior Manager position is within the Marketing Transformation vertical of Accenture GN Song. The individual would work at the heart of the top global Life Sciences (Pharmaceuticals, Biotechnology and Medical Technology) and would collaborate on innovative projects while bringing in deep industry knowledge and Marketing skills. The key responsibilities will include Strong project management skills to plan, execute, and deliver content initiatives successfully. This includes managing timelines, budgets, resources, and coordinating cross-functional teams. An analytical & data driven mindset to drive result-oriented decisions Exposure and experience in roles across the marketing value chain, primarily in the life sciences or allied industries as detailed out below. Consulting & Advisory service Market Research Analysis and assessment of the pharmaceutical market across disease areas and opportunity identification for new launches, indication expansions, identify emerging trends, competitive landscapes, and new opportunities within the life sciences sector. Competitor benchmarking, patient journey mapping, segmentation & targeting Digital Marketing Develop E2E strategy & campaigns: Liaise with key client stakeholders in the marketing teams to design strategies for omni-channel marketing campaigns. Lead development of content marketing, social media, and web engagement programs for the client, ensuring that they are aligned with the overall content strategy. In-depth knowledge of branding, creative development and execution, digital marketing, and campaign deployment and optimization Provide expertise on Content design and campaign execution: Able to provide a perspective on identification and selection of the right digital channels and content types based on campaign objectives. Able to understand client requirements based on their briefs & ideate to appropriate creative designs. Support end to end campaign execution and suggest ways for optimization. Marketing Technology Lead platform assessment and solution design : Understand the marketing value chain across process, technology & people. Conduct a thorough assessment, propose a solution along with an operating model & define KPIs for different marketing technologies Adobe / SF / Veeva. Have an understanding of the regulatory, compliance and governance landscape in the industry and build frameworks for scale up. MarTech Consulting Projects: Lead projects focusing on optimizing the MarTech stack and develop use cases to improve utilization of existing MarTech stack. Research, evaluate and recommend new martech systems and suppliers. Keep a holistic understanding of existing and upcoming martech platforms and how they connect into the broader marketing technology landscape. Tools & Platforms: Hands on experience on Mar-tech tools such as Adobe campaign, Marketo, Adobe, Cloud, Google Marketing platform, Google Ads, Pega decisioning, SFMC etc. Value realization : Crafting a value tree and developing business cases for implementation and scale up Gen AI Be aware of the latest AI developments in the Life Science industry and be able to co-create customized solutions for the client to meet their objectives. Have experience in CDP tools and platforms. Design and implement GenAI use cases Sales & Business Development Generating new business engagements:Drive new business opportunities by identifying and pursuing new leads, defining GTM strategy, facilitate client discussions and presentations to drive new business and client relationships. Own and drive RFP/RFI response coming in from Life Science customers Practice Development Take on leadership role:Support overall growth of practice across all the pillars Marketing as well as sales, & service through a combination of business development, talent management, oversight of delivery work, and thought leadership. Collaborate with Salesforce, Veeva, Adobe, IQVIA etc. business groups, to enable business capabilities with agility, velocity, and quality while optimizing costs. Establish a strong network with key stakeholders in the Accenture ecosystem, across geographies to socialize and amplify the GN Song capabilities, operating model and ways of working to generate demand and meet the KPIs Lead and motivate teams with diverse skills and backgrounds. Manage and mentor talented teams of consultants and technologists supporting, providing input and guidance into the talent strategy and actively participate in engagement, capability development activities. Read about us. Whats in it for you An opportunity to work on with key G2000 clients Potential to with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your to grow your skills, industry knowledge and capabilities Opportunity to thrive in a that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. Qualification Your experience counts! MBA from a tier 1 institute with preferably bachelors degree in marketing, Journalism, Communications, or a related field Proven working experience (8+ years) in digital marketing/Advertising platforms and in delivering marketing solutions, particularly within the Life Sciences Industry In-depth knowledge of branding, creative development and execution, digital marketing, and campaign deployment and optimization Experience in working with middle to senior management levels within existing organization / client organizations Experience in working with Agencies or working in a Marketing agency for Life Sciences Clients Strong understanding of marketing, advertising technologies (with hands on) and ability to apply technology know-how to better how our clients reach out to their customers

Role & responsibilities: Candidate should have 2-5 years of experience of Clinical Data Manage (CDM) with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in 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.

Role & responsibilities: Candidate should have 2-5 years of experience of Clinical Data Manage (CDM) with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in 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.

Job Description: Minimum 5 to 8 years experience in Statistical Programming in clinical domain Experience and understanding of ICH GCP principles and clinical drug development process Good knowledge of CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming Preferred Educational Qualification for the role: Bachelors or Masters degree or equivalent in statistics, mathematics, life science, engineering or computer related subject Essential Experience for the Role : Good knowledge and hands on experience in R Statistical Programming in Clinical Domain

Minimum 9 + years of experience with Pharmaceutical or CRO industry engaged in Clinical and Preclinical Research Good understanding of applied statistical principles and modeling in the design and analysis of clinical studies Good understanding of ICH and regulatory guidelines Experience in CDISC SDTM and Adam standards Good knowledge and hands on experience in Base SAS, SAS / STAT, SAS /Graph modules and R Statistical programming. Good communication and interpersonal skills Experience in handling domain interactions with the customer. Preferred Educational Qualification for the role: Masters or Doctorate level degree in Biostatistics, Statistics, Mathematics or related fields . Essential Experience for the Role : Good knowledge and hands on experience in R and SAS Statistical Programming in Clinical Domain

Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable.

Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable.

Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable.

Job Description: Active involvement in CAPA management activities within the team. Preferably must have faced Internal /Client audit. Working knowledge of the global pharmaceutical/pharmacovigilance regulations (ICH/ Good Pharmacovigilance modules) is preferable. Knowledge of TrackWise shall be an added advantage. Interpersonal and professional skills to interact at all levels including senior executives, contractors, and colleagues. Contribute to Global PV CAPA & Deviation Management implementation and documentation by completing all required processes as assigned. Audit & Inspection CAPA Management: 1. Collaborate with company departments/teams internal and external to provide oversight and ensure proper development of CAPAs from internal quality audits and support regulatory inspections, as assigned by respective stakeholders. 2. Support the Company Main Contact (CMC) responsible for the development of responses to Audit, Regulatory Inspection or Process Deviation observations. 3. Set up and coordinate the required meetings on behalf of the CMC in order to expedite the CAPA preparation and closure process. 4. Perform the role of Assigned to Finding Owner within the eQCMS in order to support the CMC and Assigned to CAPA Owner. 5. Ensure timely and effective closure of assigned Global PV CAPAs in collaboration with the CMC, Finding and CAPA Owners. 6. Contribute to Global PV CAPA Management implementation and documentation by completing all required processes - Obtain evidence of CAPA completion. Track and monitor CAPAs with assigned stakeholders. Ensure CAPA effectiveness checks, where applicable. Deviation Management: Support the Department Manager/ Designee in planning, executing and managing deviation and its associated CAPAs through eQCMS; monitor due dates and related extensions. Set up & coordinate the required meetings with concerned Otsuka stakeholders in order to expedite creation of Deviation & its related CAPAs. Collaborate with Department Manager/Designee regarding deviation related activities, including eQCMS access. Coordinate and manage effective entry/ follow ups of PV related deviations. Support the Department manager/ Designee in reviewing the deviations and its related CAPAs. Perform the role of Originator &/or Assigned To within eQCMS. Ensure timely & effective closure of deviations & its associated CAPAs. Contribute to Global PV Deviations Management implementation and documentation by completing all required processes - Obtain evidence for Deviation completion. Track and monitor Deviations and its associated CAPAs with assigned stakeholders. Ensure CAPA effectiveness checks, where applicable. Utilize company systems as provided access/training to, including but not limited to, the following: eQCMS (i.e. TrackWise etc.) SOP system(s) SharePoint Communications (e.g. Outlook, Teams).

To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills

Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation.

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

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi, We are hiring for the Leading ITES Company for Medical Writing Role. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Min 1 Year Experience in Clinical Study and Summary Writing Common Technical Document. b) Should have Experience in making Clinical Study Pharmacology Report, Clinical Study Report and Clinical Summary of Safety c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396 Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

Hi, We are hiring for the ITES Company for the Clinical SAS + SQL Programmer Profile. Job Description: Minimum 4 years of experience in any CDMS application. To perform a wide range of Clinical Data Management activities resulting in high quality database within stipulated timelines. To provide expertise in programming concepts to the Data Management team Must be able to develop the connection with the stake holders by pro-actively communicating over the calls and handling the queries by resolving them on the spot or later depending on the nature of the problem. Must be able to contribute the solutions to the DMs or Medical scientist for their New requirements either programmatically or convincing them with the technical limitations, if any, along with providing alternative solution. Must have capability to develop new Macros in SAS or modify any SAS Macros that are used globally throughout studies as a part of automation. Preferred Skills: Excellent interpersonal and communication skills Capability to lead by motivation and exle. Strong knowledge in SAS macros is required. General knowledge of Clinical Trials and Pharmaceutical Industry Oracle/PL SQL, CDMS like SAS, Inform etc Key Skills: a) Minimum 4 years of experience in any Clinical Data Management application. b) Should have Oracle/PL SQL, CDMS like SAS, Inform etc c) Any Medical Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Pune ) Type : Job Code # 483 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 484 b) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 485

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician 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 # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 95 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 98

Hi , WE are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Nagpur ) Type : Job Code # 85 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 86

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Pune ) Type : Job Code # 96 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 97