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3.0 - 7.0 years

6 - 10 Lacs

Chennai, Bengaluru

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Site Specialist II - Office Based - India ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Site Specialist II to join our diverse and dynamic team. As a Site Specialist II at ICON, you will play a key role in maintaining critical clinical systems, supporting site activation activities, and contributing to the smooth delivery of trials through effective technical coordination, system management, and regulatory compliance. What you will be doing Manage and support ICON s Investigator Database across production, development, and test environments, ensuring performance and system readiness. Provide application support by implementing, configuring, and testing enhancements and new releases, working closely with end users and IT teams. Resolve user issues and service requests via ServiceNow, manage user access, and maintain system and training documentation. Support the Investigator Survey Tool and ensure successful integration with ICON systems, including Salesforce. Collaborate with Site Partners to facilitate site activation, ensuring timely collection and tracking of regulatory and start-up documentation in accordance with ICH/GCP and local regulatory requirements. Your profile Experience in application support, technical operations, or system administration within clinical research, life sciences, or healthcare. Prior experience working with Salesforce systems , including managing user access, troubleshooting, and maintaining data integrity. Strong problem-solving skills and the ability to communicate effectively across cross-functional teams and global stakeholders. Knowledge of regulatory processes related to clinical trial start-up and site activation, including documentation and TMF compliance. Working knowledge of ICH/GCP guidelines, country-specific regulations, and service management tools such as ServiceNow. #LI - KT1 What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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3.0 - 6.0 years

5 - 9 Lacs

Chennai, Bengaluru

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Site Specialist II - Office Based - India We are currently seeking a Site Specialist II to join our diverse and dynamic team. As a Site Specialist II at ICON, you will play a key role in maintaining critical clinical systems, supporting site activation activities, and contributing to the smooth delivery of trials through effective technical coordination, system management, and regulatory compliance. What you will be doing Manage and support ICON s Investigator Database across production, development, and test environments, ensuring performance and system readiness. Provide application support by implementing, configuring, and testing enhancements and new releases, working closely with end users and IT teams. Resolve user issues and service requests via ServiceNow, manage user access, and maintain system and training documentation. Support the Investigator Survey Tool and ensure successful integration with ICON systems, including Salesforce. Collaborate with Site Partners to facilitate site activation, ensuring timely collection and tracking of regulatory and start-up documentation in accordance with ICH/GCP and local regulatory requirements. Your profile Experience in application support, technical operations, or system administration within clinical research, life sciences, or healthcare. Prior experience working with Salesforce systems , including managing user access, troubleshooting, and maintaining data integrity. Strong problem-solving skills and the ability to communicate effectively across cross-functional teams and global stakeholders. Knowledge of regulatory processes related to clinical trial start-up and site activation, including documentation and TMF compliance. Working knowledge of ICH/GCP guidelines, country-specific regulations, and service management tools such as ServiceNow.

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5.0 - 10.0 years

7 - 11 Lacs

Kochi

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As a Senior MDM Developer, you will play a critical role in designing, developing, and optimizing Master Data Management (MDM) solutions. You will work closely with business and technical teams to ensure data integrity, efficient integration, and compliance with enterprise standards. Your expertise in MDM platforms, data modeling, and integration technologies will be key to delivering high-quality solutions. Key Responsibilities: Design, develop, and implement MDM solutions based on business requirements. Ensure data quality, consistency, and governance across multiple domains. Collaborate with architects and business analysts to define MDM strategies and best practices. Develop integrations between MDM platforms and enterprise applications using APIs and ETL tools. Optimize data models, workflows, and MDM performance for scalability and efficiency. Troubleshoot and resolve data-related issues, ensuring system reliability and integrity. Stay updated with emerging MDM technologies and trends to enhance technical capabilities. Required Qualifications: Bachelor s degree in Computer Science, Engineering, or a related field. 5+ years of experience in MDM development and implementation. Hands-on experience with platforms such as Reltio, Informatica, DataBricks, Azure, Oracle, and Snowflake. Strong expertise in data integration, ETL processes, and API development. Solid understanding of data governance, quality management, and compliance standards. Experience working with multiple data sources, country-specific data models, and life sciences MDM implementations. Excellent problem-solving skills and the ability to work in a fast-paced environment. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at Save this job LEARN ABOUT HOW WE WORK Join our Global Talent Network Let s stay connected. Sign up to receive alerts when new opportunities become available that match your career ambitions.

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5.0 - 10.0 years

11 - 15 Lacs

Bengaluru

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Job Overview Provides high quality, on-time input to client projects in the life sciences field. Assignments range in complexity from basic analysis and problem solving to assisting in the development of more complex solutions. May serve as project leader for small teams or work streams. Essential Functions Assists with the review and analysis of client requirements or problems and assists in the development of proposals and client solutions. Assists in the development of detailed documentation and specifications. Performs quantitative or qualitative analyses to assist in the identification of client issues and the development of client specific solutions. Assists in the design/structure and completion of presentations that are appropriate to the characteristics or needs of the audience. Develops, and may present, complete client deliverables within known/identified frameworks and methodologies. Proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities. Engagement based responsibilities are assigned and managed by Senior Consultants, Engagement Managers or Principals. Qualifications Bachelors Degree Req 5-10 years of related experience Req Works willingly and effectively with others in and across the organization to accomplish team goals. Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline. Knowledge of consulting methods, tools and techniques, related to one s functional area. Knowledge of current events and developments within an industry and major competitors. Knowledge and understanding of the marketplace. Knowledge of professional/trade associations, key people and companies. Effective time management skills. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at Save this job LEARN ABOUT HOW WE WORK Join our Global Talent Network Let s stay connected. Sign up to receive alerts when new opportunities become available that match your career ambitions.

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4.0 - 5.0 years

6 - 7 Lacs

Chennai

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Senior Investigator Payment Coordinator - India, Chennai - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an Senior Investigator payments coordinator to join our diverse and dynamic team. The Sr IPC will Liaise with all other ICON departments such as Clinical, PTS, IT, Finance, legal and contracts to ensure payment queries are speedily resolved . The candidate will have a successful background of Clinical trial payments experience. What You Will Be Doing: Support Investigator Payments team with set up and maintenance of ICON s investigators payments as appropriate. Relationship Building: Utilize your exceptional relationship-building skills to collaborate effectively with both internal and external partners daily, fostering strong connections that facilitate financial processes. Client Relationship Management: Balance client relationships, ensuring their satisfaction and addressing any concerns promptly. Support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract Review payments in line with site contracts and visit data to ensure sites are being paid in a timely accurate and efficient manner and escalate delays/ issues appropriately Set up, organize and maintain clinical study/ IPG and supporting documentation as appropriate. Work with team lead/supervisor as required to quality check /review work completed by internal IPG staff and other departments Review all site contracts and accurately set up the proposed payees and budget schedule as governed by the signed Investigator contract. Ensure ICON s reputation for excellence is carried through and maintained throughout all IPG administrative processes and highlight areas for improvement as needed Your Profile: 4-5 years of experience within a similar role within Clinical trial payments. Outstanding Excel skills, if you have Oracle Financials that is preferred. Demonstrate knowledge of site & study level reconciliations. Knowledge of general accounting principles would also be a plus. Strong attention to detail and accuracy skills with the ability to coordinate and multitask What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

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4.0 - 5.0 years

6 - 7 Lacs

Chennai

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Senior Investigator Payment Coordinator - India, Chennai - Hybrid, Office-Based We are currently seeking an Senior Investigator payments coordinator to join our diverse and dynamic team. The Sr IPC will Liaise with all other ICON departments such as Clinical, PTS, IT, Finance, legal and contracts to ensure payment queries are speedily resolved . The candidate will have a successful background of Clinical trial payments experience. What You Will Be Doing: Support Investigator Payments team with set up and maintenance of ICON s investigators payments as appropriate. Relationship Building: Utilize your exceptional relationship-building skills to collaborate effectively with both internal and external partners daily, fostering strong connections that facilitate financial processes. Client Relationship Management: Balance client relationships, ensuring their satisfaction and addressing any concerns promptly. Support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract Review payments in line with site contracts and visit data to ensure sites are being paid in a timely accurate and efficient manner and escalate delays/ issues appropriately Set up, organize and maintain clinical study/ IPG and supporting documentation as appropriate. Work with team lead/supervisor as required to quality check /review work completed by internal IPG staff and other departments Review all site contracts and accurately set up the proposed payees and budget schedule as governed by the signed Investigator contract. Ensure ICON s reputation for excellence is carried through and maintained throughout all IPG administrative processes and highlight areas for improvement as needed Your Profile: 4-5 years of experience within a similar role within Clinical trial payments. Outstanding Excel skills, if you have Oracle Financials that is preferred. Demonstrate knowledge of site & study level reconciliations. Knowledge of general accounting principles would also be a plus. Strong attention to detail and accuracy skills with the ability to coordinate and multitask Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

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2.0 - 4.0 years

3 - 7 Lacs

Pune

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Description. Regulatory Associate. 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. Essential Functions. Assists with preparation of product development documents including gap analyses and clinical development plans.. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. 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. Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include the creation of submission documents to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities.. Show more Show less

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2.0 - 5.0 years

4 - 7 Lacs

Bengaluru

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Job Overview Join global organization with 82000+ employees around the world, as a Senior SQL Developer based in IQVIA Bangalore. You will be part of IQVIA s world class technology team and will be involved in design, development, enhanced software programs or cloud applications or proprietary products. Qualifications Excellent data skills (data cleansing, manipulation, analysis) Intermediate Excel skills (pivot tables, complex formulas, pivot tables) Strong SQL programming skills Detail oriented, process documentation skills Strong communication and interpersonal skills Able to work with business team to probe, understand, and execute project requirements Excellent problem-solving and analytical skills Basic to intermediate knowledge of statistics Experience with data visualization/ BI software - Tableau, MicroStrategy, etc. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

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2.0 - 7.0 years

4 - 9 Lacs

Bengaluru

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Medables mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences. Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place. 1. Responsibilities Develop and integrate algorithms for data transfers, compliance reports and other analyses that are useful for measuring the performance and/or delivering a successful clinical trial Present information in a statistically valid and impactful way using data visualization techniques and tools such as R Shiny, Looker and SpotFire Represent the Data Science team in internal and external meetings to discuss data transfer and report requirements Support Data Science process improvement activities under the guidance of the Senior Data Scientists Other duties as assigned 2. Experience 2+ years working in Data Science, Statistics or Programming role or a combination of education and experience 3. Skills Highly analytical with a strength for analysis, math and statistics Critical thinking and problem-solving skills Experience in data processing and mining Analytical mind and business acumen Problem-solving aptitude Excellent communication and presentation skills Confident in data storytelling Knowledge of the drug development industry and the role data plays in clinical trials R programming language, Python, SQL, SAS required 4. Education, Certifications, Licenses Bachelor s degree in Mathematics, Statistics, Data Science or related field 5. Travel Requirements As required At Medable, we believe that our team of Medaballers is our greatest asset. That is why we are committed to your personal and professional well-being. Our rewards are more than just benefits - they demonstrate our commitment to providing an inclusive, healthy and rewarding experience for all our team members. Flexible Work Remote from the start, we believe in a flexible employee experience Compensation Competitive base salaries Annual performance-based bonus Stock options for employees, aligning personal achievements to Medables success Health and Wellness Comprehensive medical, dental, and vision insurance coverage Carrot Fertility Program Health Saving Accounts (HSA) and Flexible Spending Accounts (FSA) Wellness program (Mental, Physical and Financial) Recognition Peer-to-peer recognition program, celebrating achievements and milestones Community Involvement Volunteer time off to support causes you care about Medable is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or would like to request an accommodation due to a disability, please contact us at hr@medable.com .

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2.0 - 7.0 years

4 - 9 Lacs

Bengaluru

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Medables mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences. Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place. 1. Responsibilities Responsible for implementing visual elements that users see and interact with in a web application Develop new user-facing features Build reusable code and libraries for future use Ensure the technical feasibility of UI/UX designs Optimize application for maximum speed and scalability Ensure changes are validated before submitting to back-end Collaborate with other team members and stakeholders Develop functional and appealing web- and mobile-based applications based on usability Provide website maintenance, bug fixing, and enhancements Write functional requirement documents and specifications Create quality mockups and prototypes on tight timelines Assist back-end developers with coding and troubleshooting Create cascading style sheets (CSS) that are consistent across all browsers and platforms Other duties as assigned 2. Experience 2+ years working as a Developer or a combination of education and experience 3. Skills Proficient understanding of web markup, including HTML5, CSS3 Basic understanding of server-side CSS pre-processing platforms, such as LESS and SASS Proficient understanding of client-side scripting and JavaScript frameworks, including jQuery Good understanding of advanced JavaScript libraries and frameworks Good understanding of asynchronous request handling, partial page updates, and AJAX Basic knowledge of image authoring tools, to be able to crop, resize, or perform small adjustments on an image Proficient understanding of cross-browser compatibility issues and ways to work around them Proficient understanding of code versioning tools Good understanding of SEO principles and ensuring that application will adhere to them HTML, CSS, Javascript, Docker, Git 4. Education, Certifications, Licenses Bachelors degree in Computer Science or a related field preferred 5. Travel Requirements As required At Medable, we believe that our team of Medaballers is our greatest asset. That is why we are committed to your personal and professional well-being. Our rewards are more than just benefits - they demonstrate our commitment to providing an inclusive, healthy and rewarding experience for all our team members. Flexible Work Remote from the start, we believe in a flexible employee experience Compensation Competitive base salaries Annual performance-based bonus Stock options for employees, aligning personal achievements to Medables success Health and Wellness Comprehensive medical, dental, and vision insurance coverage Carrot Fertility Program Health Saving Accounts (HSA) and Flexible Spending Accounts (FSA) Wellness program (Mental, Physical and Financial) Recognition Peer-to-peer recognition program, celebrating achievements and milestones Community Involvement Volunteer time off to support causes you care about Medable is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or would like to request an accommodation due to a disability, please contact us at hr@medable.com .

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3.0 - 4.0 years

5 - 6 Lacs

Bengaluru

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Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision. Essential Functions Acts as a Regulatory Team Leader on more complex projects, which may include technical writing; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments; Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate; May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person; May act as reviewer for regulatory standard operating procedures, as assigned and appropriate; May prepare and deliver regulatory training to IQVIA small groups or individuals; Performs other tasks or assignments, as delegated by Regulatory management; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline Req At least 3-4 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

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3.0 - 7.0 years

5 - 9 Lacs

Gurugram, Bengaluru

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The Global Analyst will perform, manage, and coordinate activities associated with data analysis leveraging IQVIA Connected Intelligence Real-World Data (RWD) and clinical data assets for multiple Research & Development projects while closely working with our team of Therapeutic Analytic Leads. They will also ensure standardization in how IQVIA uses data, tools, and process to inform quality decision making at the indication, program, and study level. Responsibilities: Utilizes the IQVIA Connected-intelligence data sets and resources to define and enhance clinical trial strategy, both pre- and post-award Communicates with internal stakeholders to align on requirements, capabilities, and delivery of data analytics Drives the methodology and implementation of data analytics deliverables, including country evaluation and ranking, competitive landscape assessment, historical recruitment analysis, and patient density analytics Generates patient insights using real-world data to support site targeting activities Coordinates the collection of site outreach data to support development of the country/site strategy Qualifications: Bachelor s in Life Sciences, Information Technology, Computer Science, Statistics or related field Experience in data analytics, clinical research, or consulting in the pharmaceutical or healthcare industries Experience working with large volumes of electronic data, such as medical claims, sales, prescriptions, electronic medical records/electronic health records, or similar General knowledge of the pharmaceutical and healthcare market, as well as familiarity with drug development processes Experience working with global teams based across multiple geographies is preferred Experience leveraging business intelligence tools such as Power BI or Tableau is preferred Hands-on experience using object oriented and/or scripting languages (Python, R, Spark, or PySpark) and/or to relational databases (MS SQL Server, Oracle SQL, or PostgreSQL) would be a plus Skills Strong attention to detail Effective presentation skills Proficiency using MS Excel and MS PowerPoint Logical approach to problem solving and task prioritization Excellent communication (verbal/written) and ability to interact with dynamic, global teams Ability to acquire new skills and evolve to new systems . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

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3.0 - 7.0 years

5 - 9 Lacs

Gurugram, Bengaluru

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The Global Analyst will perform, manage, and coordinate activities associated with data analysis leveraging IQVIA Connected Intelligence Real-World Data (RWD) and clinical data assets for multiple Research & Development projects while closely working with our team of Therapeutic Analytic Leads. They will also ensure standardization in how IQVIA uses data, tools, and process to inform quality decision making at the indication, program, and study level. Responsibilities: Utilizes the IQVIA Connected-intelligence data sets and resources to define and enhance clinical trial strategy, both pre- and post-award Communicates with internal stakeholders to align on requirements, capabilities, and delivery of data analytics Drives the methodology and implementation of data analytics deliverables, including country evaluation and ranking, competitive landscape assessment, historical recruitment analysis, and patient density analytics Generates patient insights using real-world data to support site targeting activities Coordinates the collection of site outreach data to support development of the country/site strategy Qualifications: Bachelor s in Life Sciences, Information Technology, Computer Science, Statistics or related field Experience in data analytics, clinical research, or consulting in the pharmaceutical or healthcare industries Experience working with large volumes of electronic data, such as medical claims, sales, prescriptions, electronic medical records/electronic health records, or similar General knowledge of the pharmaceutical and healthcare market, as well as familiarity with drug development processes Experience working with global teams based across multiple geographies is preferred Experience leveraging business intelligence tools such as Power BI or Tableau is preferred Hands-on experience using object oriented and/or scripting languages (Python, R, Spark, or PySpark) and/or to relational databases (MS SQL Server, Oracle SQL, or PostgreSQL) would be a plus Skills Strong attention to detail Effective presentation skills Proficiency using MS Excel and MS PowerPoint Logical approach to problem solving and task prioritization Excellent communication (verbal/written) and ability to interact with dynamic, global teams Ability to acquire new skills and evolve to new systems

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5.0 - 8.0 years

7 - 10 Lacs

Mumbai

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Responsible for the on-time completion of projects or components of large, complex projects for clients in the life sciences field. Identifies and elevates potential new business opportunities and assists in the sales process. Essential Functions Participates or leads teams in the design, development and delivery of consulting projects or components of larger, complex projects. Reviews and analyzes client requirements or problems and assists in the development of proposals of cost effective solutions that ensure profitability and high client satisfaction. Provides direction and guidance to Analysts, Consultants, and where relevant, to Statistical Services assigned to engagement. Develops detailed documentation and specifications. Performs qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client specific solutions. Designs, structures and delivers client reports and presentations that are appropriate to the characteristics or needs of the audience. May deliver some findings to clients. Recommends improvements and alternative solutions to resolve problems. May identify new business opportunities of follow-on work and new leads at assigned client. Provides follow-up with client after project deliverable has been completed to ensure client satisfaction. Proactively develops broader and deeper knowledge of related consulting methodologies and life sciences market through on the job experience and participation in training opportunities. Begins to develop CoE specific subject matter expertise. When acting as Project Manager, proactively manages project timelines and manages day to day communication with the client and team members. Qualifications Bachelors Degree Req Masters Degree Business Administration Pref 5-8 years of related experience in consulting and/or life sciences industry Req Possesses solid project management skills and client influencing and relationship building skills. Works willingly and effectively with others in and across the organization to accomplish team goals. Experienced with developing consultative relationships with senior level managers and executives at clients in the life science industry. Ability to manage multiple projects, juggle priorities and deliver on tight deadlines. Knowledge of consulting methodologies, tools and techniques related to functional area. Knowledge of key issues and current developments in the life science industry. Excellent presentation, communication and client influencing skills. Has established network and referral contacts. Has necessary subject matter expertise to effectively manage projects within a given CoE.

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6.0 - 11.0 years

8 - 13 Lacs

Bengaluru

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Medables mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences. Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place. 1. Responsibilities Identify opportunities to build data science solutions that address complex business problems Lead cross-functional teams in the implementation of Data Services tools Support and lead the creation of relevant dummy data to test algorithms based on clinical study protocols and client needs Collaborate with internal stakeholders to implement data standardization across our products Communicate key insights and findings Lead/Collaborate on deep-dives to identify root causes of data issues in systems owned by Data Services/Other Departments Represent Data Science/Data Services at internal and external meetings with no oversight from Data Services leadership Mentor junior team members to drive development of the Data Services team to always produce High Quality Data Services deliverables Other duties as assigned 2. Experience 6+ years working with data analyses/reports to provide data-driven conclusions / direction, of which at least 50% is directly related to clinical trials (especially DCTs) within the pharmaceutical industry Practical experience in defining and maintaining Data Quality/Integrity Demonstrated expert knowledge of the role that decentralized trials (DCTs) and data play in clinical drug development Experience in leading cross-functional teams and representation of the data component Ability to read and interpret clinical study protocols and other internal/external documents that define products / solutions / implementation plans, particularly where data form the key component of the deliverable 3. Skills High attention to detail in order to draw insightful and data-driven business-relevant conclusions Excellent communication and presentation skills with experience presenting to both internal and external stakeholders Critical thinking and problem-solving skills 4. Education, Certifications, Licenses Bachelor s Degree in related filed i.e. Data Science, Computer Science or Mathematics 5. Travel Requirements As required At Medable, we believe that our team of Medaballers is our greatest asset. That is why we are committed to your personal and professional well-being. Our rewards are more than just benefits - they demonstrate our commitment to providing an inclusive, healthy and rewarding experience for all our team members. Flexible Work Remote from the start, we believe in a flexible employee experience Compensation Competitive base salaries Annual performance-based bonus Stock options for employees, aligning personal achievements to Medables success Health and Wellness Comprehensive medical, dental, and vision insurance coverage Carrot Fertility Program Health Saving Accounts (HSA) and Flexible Spending Accounts (FSA) Wellness program (Mental, Physical and Financial) Recognition Peer-to-peer recognition program, celebrating achievements and milestones Community Involvement Volunteer time off to support causes you care about Medable is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or would like to request an accommodation due to a disability, please contact us at hr@medable.com .

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1.0 - 3.0 years

4 - 8 Lacs

Pune

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Description. Sr Medical Writer (CTT). 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. Mentors and leads less experienced medical writers on complex projects, as necessary.. Acts as lead for assigned writing projects.. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. -Develops or supports a variety of documents that include, but not limited to:. Clinical study protocols and clinical protocol amendments;. Clinical study reports;. Patient narratives;. Clinical development plans;. IND submissions and annual reports;. Integrated summary reports;. NDA and (e)CTD submissions;. Investigator brochures, as well as;. Clinical journal manuscripts, clinical journal abstracts, and client presentations.. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team providing review commentson draft and final documents.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.. Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Trial transparency deliverables, protocol registration, protocol maintenance task, result posting for(CT.gov and EudraCT). Redaction of protocol and SAP (Statistical Analysis Plan). Qualifications. Minimum 7 years of experience in Medical Writing and atleast 5+ years of experience in Clinical Trial Transparency(CTT). Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. 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. Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus. Leading the clear and accurate completion of medical writing deliverables. Managing medical writing activities associated with individual studies. Coordinating these activities within and across departments. Completing a variety of documents, adhering to established regulatory standards. Coordinating quality and editorial reviews. Acting as peer reviewers for the internal team. Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs. Performing online clinical literature searches and complying with copyright requirements. Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff. Mentoring and leading less experienced medical writers on complex projects. Developing deep expertise on key topics in the industry and regulatory requirements. Working within budget specifications for assigned projects. Show more Show less

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0.0 - 5.0 years

2 - 5 Lacs

Kolkata, Mumbai, New Delhi

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Commitment: 10-20 hours/week for 1–2 months (with potential extension).. Compensation: Among the highest in the industry, aligned with experience and expertise.. Who should apply. We are not looking for general translators, freelancers, or content writers. We are looking for the top 1% of academic and cultural experts who meet all the following:. Native fluency in one or more of the following (reading and writing):. Bengali, Gujarati, Hindi, Kannada, Malayalam, Marathi, Odia, Tamil, Telugu, or Punjabi. Strong command of English (for prompt interpretation and evaluation). Deep academic or research expertise in History or Literature & Linguistics. PhD, MPhil, or Master’s degree is preferred, but credible, extensive experience in the field is also valued.. Passion for precision, language, and cultural nuance. Based in the respective state/region where the language is natively spoken. Comfortable using AI tools like ChatGPT, Claude, Gemini, etc.. Your Role? Challenge and Teach AI Models to Understand the Depth of Indian History and Literature in Your Language. Design advanced, historically and culturally rooted prompts in your regional language that challenge state-of-the-art AI models. Evaluate model outputs for factual accuracy, literary nuance, historical context, tone, and regional relevance. Identify blind spots and weaknesses in current AI understanding within your domain. Collaborate with an international team shaping how AI understands Indian languages, history, literature, and knowledge systems. This is not a translation or content-writing gig. We're seeking true experts to shape the next generation of language models.. Show more Show less

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1.0 - 3.0 years

3 - 7 Lacs

Pune

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Description. Medical Writer II (CTT). 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. Mentors less experienced medical writers on projects, as necessary.. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Working knowledge of drug development process and regulatory guidelines.. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned.. Minimal travel may be required (less than 25%).. Qualifications. Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing.. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries.. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. 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

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15.0 - 19.0 years

50 - 100 Lacs

Bengaluru

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Medables mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences. Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place. 1. Responsibilities Strategic Leadership Develop and execute the India strategy in alignment with Medable s global vision and business objectives. Identify and drive growth opportunities within the GCC to enhance its strategic value and operational impact. Serve as a key voice in shaping global strategies with localized expertise and insights. Operational Management & Delivery Excellence Oversee end-to-end service delivery across all functional areas based in India. Ensure the India team meets or exceeds expectations for quality, productivity, compliance, and innovation. Drive adoption of best practices and continuous improvement across all operational processes. Talent Strategy & Development Lead efforts to attract, retain, and develop top-tier talent in India. Promote a high-performance culture anchored in Medable s mission and values. Champion employee engagement through inclusive programs, leadership development, and career growth opportunities. Financial Performance & Cost Optimization Own and manage the GCC budget, including cost controls, financial forecasting, and resource allocation. Ensure operational efficiency and continuous improvement to maximize ROI and profitability. Stakeholder Management & Global Collaboration Act as the primary liaison between Medable India and global leadership teams. Foster strong partnerships across departments to enable seamless global operations. Communicate India s contributions and needs effectively to Medable s executive team. Compliance, Risk & Regulatory Adherence Ensure that all operations within the GCC comply with local laws and global regulatory standards. Build and maintain a robust risk management framework to identify and address operational challenges. Lead internal compliance audits and ensure alignment with Medable s quality and security protocols. Market Expansion & Industry Engagement Represent Medable India in industry forums, government panels, and regulatory discussions. Build strategic partnerships with Indian and global stakeholders to strengthen Medable s market presence. Position the India GCC as a leader in decentralized clinical trials and eCOA (electronic Clinical Outcomes Assessment). Employer Branding & Workforce Development Drive initiatives to make Medable a recognized employer of choice in the Indian healthcare tech space. Develop academic and institutional partnerships to build a future-ready talent pipeline. ESG and Corporate Social Responsibility (CSR) Align India operations with Medable s global ESG goals. Design and implement CSR programs focused on digital health equity, clinical research education, and community engagement. Other duties as assigned. 2. Experience 15+ years of experience in operations, or general management roles, preferably within the healthcare, technology, or clinical research sectors, or a combination of education and experience. Demonstrated experience leading global capability centers or international teams. Proven success in operational excellence, talent leadership, and financial management. 3. Skills Strong understanding of India s regulatory landscape, employment practices, and industry dynamics. Strategic thinking with a global mindset. Operational discipline and financial acumen. Inspirational leadership and team building. Executive presence with strong communication skills. Change management and growth orientation. 4. Education, Certifications, Licenses Bachelor s degree required Master s degree (MBA or equivalent) preferred. 5. Travel Requirements As required. At Medable, we believe that our team of Medaballers is our greatest asset. That is why we are committed to your personal and professional well-being. Our rewards are more than just benefits - they demonstrate our commitment to providing an inclusive, healthy and rewarding experience for all our team members. Flexible Work Remote from the start, we believe in a flexible employee experience Compensation Competitive base salaries Annual performance-based bonus Stock options for employees, aligning personal achievements to Medables success Health and Wellness Comprehensive medical, dental, and vision insurance coverage Carrot Fertility Program Health Saving Accounts (HSA) and Flexible Spending Accounts (FSA) Wellness program (Mental, Physical and Financial) Recognition Peer-to-peer recognition program, celebrating achievements and milestones Community Involvement Volunteer time off to support causes you care about Medable is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or would like to request an accommodation due to a disability, please contact us at hr@medable.com .

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3.0 - 6.0 years

8 - 11 Lacs

Bengaluru

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Job Description:. Weekly Hours:. 40. Time Type:. Regular. Location:. IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge CityAdm: Argus Building, Sattva, Knowledge City. It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.. Show more Show less

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6.0 - 8.0 years

8 - 12 Lacs

Vellore

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As A Medical Coding Associate (MCA) at WWS you will be responsible for assigning the appropriate code to describe a particular type of service to a patient. Ensuring that the codes are appropriately applied during the insurance process of billing, including removing the information from documentation, assigning the appropriate codes, and creating a claim for reimbursement.. What We Expect. Any Life Science Graduate.. Proficient computer skills.. Ability to understand Medical Terminologies (Physiology and Anatomy) is a great advantage.. Good communication and analytical skills.. Should have 3+ years of experience in medical coding.. Flexibility in shifts is appreciated.. A Medical Coder’s Ideal Day at WWS. Review patient information.. Converging compliance.. Input medical codes.. Audit codes.. What You Can Expect. Full-time, salaried position creamed with welfare programs.. Competitive salary and module specific training in the core space with recognition potential and annual bonus.. Performance appraisals.. Attendance Incentives.. Working with the best talent in the industry. Conducive intangible environment with dynamic benefits.. Why Consider a Medical Coding Career With WWS?. With a very appealing work environment at WWS, our setting made it easier to build relationships with other staff members and clients. You may also have an opportunity to learn other aspects of medical office work on the job, which can enhance your experience and qualifications.. The U.S. Bureau of Labour Statistics (BLS) projects that employment of medical secretaries, including medical coders, will grow 34% between 2016 and 2026, which is much faster than the average for all professions. This strong job outlook can make it easier for qualified coders to find work.. Benefits. Competitive salary and benefits package. Opportunity to lead a team. Chance to make a real impact. Contact us on recruiter@wonderws.com / 9047477375.. Show more Show less

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6.0 - 11.0 years

9 - 13 Lacs

Gurugram

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We are seeking a highly analytical and strategic Senior Analyst to join our CI team, supporting business-critical decisions across the pharmaceutical product lifecycle.Key Responsibilities:Monitor and analyze competitor activities across pipeline, clinical trials, regulatory, commercial, and corporate developments in assigned therapeutic areas.Synthesize findings into clear, concise, and impactful deliverables such as landscape assessments, competitor profiles, war games, SWOT analyses, and executive briefings.Contribute to CI deliverables supporting brand planning, forecasting, launch readiness, and lifecycle management.Maintain and evolve CI processes, databases, and tools for improved efficiency and insight generation.Present insights to internal stakeholders and senior leadership with strategic recommendations. Qualifications Bachelors degree in a relevant field such as Life Sciences (Pharma, Biotechnology) Job Location

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2.0 - 5.0 years

5 - 8 Lacs

Kolkata, Mumbai, New Delhi

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We are a company dedicated to the audit and certification of national and international standards of quality and sustainability in products and processes.. We have an interdisciplinary team of professionals specialized in each industry and sector, committed to providing the highest quality service in a personalized way, generating long-term relationships with our clients and the community.. Our wide service offer, our extensive network of producers, processors and traders, our presence in fairs and seminars in different countries and our growing internationalization, make LETIS a link to the world.. Brief Job Description:. Audit preparation. Audit report preparation. Responding to technical queries.. Sending Audit Packs to Certifying office within stated timeline. Submission of Updated Audit Logs. Technical accuracy as per guidelines of audits packs. Client Satisfaction. Sociable with good market recognition and understanding. Technical Knowledge on the food sector audited. Presentable with the right mix of authority and convincing capability. Analytical capability and prompt decision making capability. Qualifications:. Essential:. Graduate/ Post Graduate in careers related to Agronomy Engineering or registered Rural Administration Technician, etc.;. To have knowledge and skills in organic production and handling techniques. At least 2 years of experience as an organic inspector in another Certifying Body (preferably in NOP regulations). Intermediate-advanced level of English (B2-C1). Desirable:. Food industry work experience with knowledge/ experience in auditing food safety management systems. with good Communication Skills , pleasing personality and proficient in computer usage. Please note it is mandatory to attach an audit log of audits conducted during your career, as well as professional references.. Show more Show less

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1.0 - 4.0 years

5 - 9 Lacs

Hyderabad

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About The Job. Our Team:. Sanofi Global Hub (SGH) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. SGH strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally.. Main Responsibilities. The overall purpose and main responsibilities are listed below:. Create HEVA communications deliverables (including manuscripts, posters, abstracts, slide decks) aligned with HEVA strategy and global HEVA communication plan across relevant business units and product teams. Manage core HEVA communication processes, templates, and products across the portfolio in accordance with the scientific and value messages aligned with Core Value Dossier, the US AMCP Dossier, and HEVA contributions as appropriate to other submissions. Ensure Core Value Decks for key products are established and maintained, making available a regularly updated synthesis of critical HEVA evidence on the value of products. Maintain accountability for adherence to the publication standard operating procedure (SOP) and other compliance expectations relevant to HEVA communication processes. Seek opportunities to innovate HEVA value communications to increase the relevance and impact of HEVA evidence and inform optimal access and reimbursement decisions. Develop and maintain therapeutic area expertise. Coach junior HEVA writers and develop and review content created by them. Manage end to end process through iEnvision (previously, Datavision/Matrix). Collaborate effectively with stakeholders: HEVA, RWE, and Scientific communication global and/or local teams.. People: (1) Maintain effective relationships with the end stakeholders within the allocated GBU and product – with an end objective to develop education and communication content as per requirement for HEVA communications; (2) Interact effectively with healthcare professionals on publication content; and (3) Constantly assist other writers (junior) in developing knowledge and sharing learning. Performance: (1) Create HEVA communications deliverables (including manuscripts, posters, abstracts, and slide decks) aligned with HEVA strategy and global HEVA communication plan across relevant business units and product teams as per agreed timelines and quality; and (2) Provide strategic support with individuals and institutions, which may serve as resources for publications purpose, etc. Process: (1) Develop complex publications material; (2) Act as an expert in the field of medical communication for the assigned therapeutic area; (3) Assist the assigned scientific communication team in conducting comprehensive publication-needs analysis; (4) Manage core HEVA communication processes, templates, and products across the portfolio in accordance with the scientific and value messages aligned with Core Value Dossier, the US AMCP Dossier, and HEVA contributions as appropriate to other submissions; (5) Ensure Core Value Decks for key products are established and maintained, making available a regularly updated synthesis of critical HEVA evidence on the value of products; (6) Maintain accountability for adherence to the publication SOP and other compliance expectations relevant to HEVA communication processes; (7) Maintain accountability for adherence to the publication SOP and other compliance expectations relevant to HEVA communication processes; (8) Implement relevant element of publication plan and associated activities for the year identified for the region; (9) Work with selected vendors within the region to deliver the required deliverables as per defined process; and (10) Design an overall plan of action based on end-user feedback and improve course content and delivery. Stakeholder: (1) Work closely with HEVA global and local teams, RWE global and local teams and scientific communication teams in regions/areas to identify publications needs and assist in developing assigned deliverables; and (2) Liaise with HEVA global and local teams to prepare relevant and customized deliverables. About You. Experience: >4 years of experience in content creation for the pharmaceutical/healthcare industry, or academia. Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment. Technical skills: Relevant training/experience in health economics, public health, epidemiology, or other relevant health-related scientific discipline (including but not limited to therapeutic area/domain knowledge exposure; knowledge of Good Publication Practice; publication submission; and/or project management). Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree. Languages: Excellent knowledge of English language (spoken and written). Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!. null. Show more Show less

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2.0 - 4.0 years

1 - 5 Lacs

Pune

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Description. Regulatory Associate (CMCPre and post approval ). 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. Assists with preparation of product development documents including gap analyses and clinical development plans.. Minimum 2 years of relevant experience. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. Qualifications. MS in science/healthcare field, or equivalent combination of education and experience.. Minimum 2 years of relevant experience. Excellent interpersonal / communication skills.. Advanced skills in Microsoft Office Applications.. Good time and project management skills, preferred.. Strong analytical skills and attention to detail.. Ability to work both as a team member and 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 preferred.. 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

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Exploring Clinical Research Jobs in India

India has emerged as a hub for clinical research with a rapidly growing job market in this field. Clinical research professionals play a crucial role in the development of new medicines and treatments, making it a rewarding career choice for those interested in the healthcare industry.

Top Hiring Locations in India

  1. Mumbai
  2. Bangalore
  3. Hyderabad
  4. Delhi
  5. Chennai

Average Salary Range

The average salary range for clinical research professionals in India varies based on experience levels. Entry-level positions can expect to earn around INR 3-5 lakhs per annum, while experienced professionals can earn upwards of INR 10-15 lakhs per annum.

Career Path

In the field of clinical research, a typical career path may involve starting as a Clinical Research Associate, advancing to Senior Clinical Research Associate, and eventually moving up to roles such as Clinical Project Manager or Clinical Operations Director.

Related Skills

Besides clinical research expertise, professionals in this field are often expected to have skills such as: - Good understanding of regulatory requirements - Strong attention to detail - Excellent communication and interpersonal skills - Data analysis and interpretation abilities

Interview Questions

  • What is the role of a Clinical Research Associate? (basic)
  • Can you explain the phases of clinical trials? (basic)
  • How do you ensure patient safety in a clinical trial? (medium)
  • What are the common adverse events observed in clinical research? (medium)
  • How do you handle protocol deviations during a clinical trial? (medium)
  • Explain the difference between informed consent and assent. (advanced)
  • How do you ensure data integrity in clinical research? (advanced)
  • What are the key regulatory bodies governing clinical research in India? (medium)
  • Describe a challenging situation you faced during a clinical trial and how you resolved it. (medium)
  • How do you stay updated with the latest developments in clinical research? (basic)
  • What are the ethical considerations in clinical research involving vulnerable populations? (advanced)
  • How do you manage multiple clinical trials simultaneously? (medium)
  • Explain the importance of Good Clinical Practice (GCP) guidelines. (basic)
  • How do you handle conflicts of interest in clinical research? (advanced)
  • What are the key differences between observational studies and clinical trials? (medium)
  • How do you ensure patient recruitment and retention in a clinical trial? (medium)
  • Can you explain the concept of randomization in clinical trials? (medium)
  • How do you ensure data confidentiality in clinical research? (medium)
  • Describe a successful clinical trial you were involved in and the key outcomes. (medium)
  • What are the key components of a clinical trial protocol? (basic)
  • How do you ensure compliance with study protocols in a clinical trial? (medium)
  • What are the challenges of conducting clinical research in India? (medium)
  • How do you handle adverse events in a clinical trial? (medium)
  • What are the key considerations when designing a clinical trial protocol? (advanced)

Closing Remark

As you prepare for interviews in the clinical research field, remember to showcase your expertise, communication skills, and commitment to patient safety. With the right preparation and confidence, you can land your dream job in this rewarding and growing industry. Good luck!

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