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3.0 - 8.0 years

5 - 15 Lacs

new delhi, pune, delhi / ncr

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Role & responsibilities Contribute to the design and implementation of AI augmented clinical data products (Protocol, ICF, CSR, etc.) and GxP-validated content generation for SDTM, ADaM, and TLG. Support development of Agentic AI solutions for specifications, data mapping, and metadata-driven workflows. Assist in delivering analysis-ready datasets for submission use cases. Collaborate in Agile projects, documenting requirements, writing user stories, and maintaining backlogs using JIRA/Retina. Participate in requirement discussions, creation of specifications, traceability, and user guides aligned with regulatory compliance. Engage with cross-functional teams to support AI-driven biometrics ...

Posted 4 hours ago

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4.0 - 9.0 years

5 - 9 Lacs

chennai, gurugram, bengaluru

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Your Role Manage and maintain IBM disk and tape storage environments, ensuring optimal performance and reliability. Set up and update SMS definitions, monitor storage groups, and perform volume initialization. Define and enforce standards for disk/tape storage, proactively monitor usage, and address potential issues. Troubleshoot performance issues in z/OS environments and support disaster recovery (DR) testing. Interface with various levels of management and business clients to resolve storage-related concerns. Maintain and manage ICF catalog structures, tape management (scratch thresholds, Tapecopy), and dataset operations (creation, deletion, recovery). Your Profile 4 to 10 years of exper...

Posted 6 days ago

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7.0 - 12.0 years

20 - 25 Lacs

mumbai

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Position Purpose India Product Control team is now 400 staff and this business management role will support India and Global business management function. The role will provide support under the four pillars of Strategy, Governance, Business Management and Projects. The individual will be responsible for the below mentioned tasks Responsibilities Direct Responsibilities Strategy o Preparation and Monitoring of budgets including monthly variance o KPI Strategy o Headcount Governance by Region/ Global o BCM and ERS coordination Governance o F24/B25 budget coordination and engagement with Global o India KPI meeting coordination (preparation, minutes, follow-up, continuous review) o Governance a...

Posted 3 weeks ago

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1.0 - 4.0 years

2 - 3 Lacs

mumbai

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Responsibilities: Prepare clinical study reports, protocols & newsletters Design medical affairs strategies Conduct literature reviews & ICH compliance checks Write scientific documents with CRF & KOL input Protocols, abstracts, posters, manuscripts Provident fund

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0.0 - 4.0 years

5 - 10 Lacs

bengaluru

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Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role As a Mainframe Storage Administrator at Kyndryl, you’ll solve complex problems and identify potential future issues across the spectrum of platforms and services. You’ll be at the forefront of new technology and modernization, working with some of our biggest clients – which means some of the biggest in the world. There’s never a typical day as...

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10.0 - 15.0 years

22 - 37 Lacs

bengaluru

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Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role As a Mainframe Strorage SME at Kyndryl, you’ll solve complex problems and identify potential future issues across the spectrum of platforms and services. You’ll be at the forefront of new technology and modernization, working with some of our biggest clients – which means some of the biggest in the world. There’s never a typical day as a System...

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4.0 - 6.0 years

8 - 10 Lacs

bengaluru

Hybrid

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eC...

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4.0 - 6.0 years

20 - 25 Lacs

gurugram

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* Exposure to Power or renewable energy sector. * Able to Publish report and newsletters * Team Handling on Project. * Support creation and visualization of outputs that will be part of client discussions and deliverables * Take ownership of project Required Candidate profile * Exp in working on M&A strategy, due diligence, and go to market plans. * Train team member on various analysis and delivery processes. * Client Engagement. * Team Management * Publish New Insides.

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8.0 - 13.0 years

15 - 27 Lacs

Bengaluru

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Job Title: Senior Medical Writer Regulatory Writing Education Requirements: MBBS / PhD / MDS / BDS / MPharm / PharmD/M.Sc/B.Pharma/B.Tech Location: Bangalore (Hybrid as applicable) Experience: 8 to12 years of experience in authoring clinical and regulatory documents supporting global filings, particularly CTD Module 2 and Module 5. Role Purpose: This role involves managing complex medical writing projects, reviewing regulatory deliverables, and mentoring junior writers. The position requires both strategic thinking and hands-on execution in support of global regulatory submissions. Key Responsibilities: Independently prepare and review regulatory documents such as clinical study reports (CSR...

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3.0 - 8.0 years

5 - 7 Lacs

Gurugram

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3+ Years Experience in an IB School. Graduate/Postgraduate with relevant experience in student career guidance. Certification in career counseling preferred.

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2.0 - 7.0 years

3 - 7 Lacs

Nagpur

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2 yrs CRC experience/ Bpharm, Mpharm/Bpharm,MBA qualification, fresher or intern in any pharmaceutical marketing/ Worked as Placement Coordinator for pharmacy college, Good Communication, Interpersonal analytical skills , establish Relationship with colleges, their placement cell, faculties, managing relationship with hospitals Doctors/investigators, handling grievance, helping out MD of company for developing patient data base, handling placement Drive event related things, establish follow up communication with CRO's/ Sponsor/hospitals IT companies regarding same.

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7.0 years

14 - 16 Lacs

Hyderabad

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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Data Acquisition Specialist Min 5 + yrs of experience in Data Acquisition domain. Expertise in Handling Non-CRF activities, able to work autonomously on th...

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7.0 years

12 - 14 Lacs

Hyderabad

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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Data Acquisition Specialist Min 2 + yrs of experience in Data Acquisition domain. Expertise in Handling Non-CRF activities, able to work autonomously on th...

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1.0 - 5.0 years

2 - 5 Lacs

Udupi, Manipal

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Role & responsibilities Performing as Sub-investigator in the assigned clinical studies Reviewing study documents Preparation of Clinical Raw data Protocol, SOP and various Regulatory compliance Protocol/ICF/CSR review Study initiation and Execution Pre study document preparation Dosing of the subjects Monitoring the study process Preparation of confinement report, clinical updates & clinical summary report Compilation of study documents as per protocol Review study documents and handing over to QA for review. Close the QA / Sponsors observation / queries Archival & Retrieval of study documents Subject safety follow-up Serving as QC in the assigned clinical studies Performing pharmacy activi...

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2.0 - 7.0 years

10 - 20 Lacs

Bengaluru

Hybrid

Minimum Qualification Requirements: Bachelors degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing(CSR/Protocol writing/IB) Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)

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1.0 - 6.0 years

7 - 14 Lacs

Ahmedabad

Work from Office

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up * Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M.Pharm (Pharmacology) with 1-5 Yrs with relevant experience Interested candidates...

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5.0 - 7.0 years

3 - 8 Lacs

Hyderabad

Hybrid

Role & responsibilities Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews. Essential Job duties and responsibilities: 1) Participate ind...

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7.0 years

12 - 14 Lacs

Hyderabad

Work from Office

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Min 5 yrs of experience in Data Acquisition domain. Expertise in Handling Non-CRF activities, able to work autonomously on the non-CRF data strategy. In-de...

Posted 3 months ago

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8.0 years

15 - 19 Lacs

Hyderabad

Work from Office

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Skills: Min 5 yrs of experience in Data Acquisition domain. Expertise in Handling Non-CRF activities, able to work autonomously on the non-CRF data strateg...

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2.0 - 4.0 years

3 - 7 Lacs

Bengaluru

Work from Office

Responsibilities: * Prepare clinical study reports and protocols. * Ensure compliance with ICF and ICH-GCP guidelines. * Collaborate on clinical research projects. * Write medical communications for regulatory submissions. Provident fund

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3.0 - 7.0 years

7 - 10 Lacs

Hyderabad

Work from Office

Role & responsibilities: Ensures that qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical studies. Maintaining current, up-to-date curriculum vitae . Assuming responsibility for the conduct of the clinical investigation. Signing the protocol Documenting the financial aspects of the trial. Disclosing conflicts of interest as described in the regulations. Ensuring adequate number of qualified staff and adequate facilities for conductance of the study properly and safely. Ensures that all persons assisting with the study are adequately informed about the protocol, the investigational product(s), and their study-related duties and func...

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10.0 - 15.0 years

22 - 37 Lacs

Bengaluru

Work from Office

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role As a Mainframe Strorage SME at Kyndryl, you’ll solve complex problems and identify potential future issues across the spectrum of platforms and services. You’ll be at the forefront of new technology and modernization, working with some of our biggest clients – which means some of the biggest in the world. There’s never a typical day as a System...

Posted 3 months ago

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4.0 - 6.0 years

8 - 10 Lacs

Bengaluru

Hybrid

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eC...

Posted 3 months ago

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6.0 - 10.0 years

15 - 25 Lacs

Bengaluru

Work from Office

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role As a Mainframe Storage Administrator at Kyndryl, you’ll solve complex problems and identify potential future issues across the spectrum of platforms and services. You’ll be at the forefront of new technology and modernization, working with some of our biggest clients – which means some of the biggest in the world. There’s never a typical day as...

Posted 3 months ago

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2 - 6 years

4 - 9 Lacs

Gandhinagar, Ahmedabad

Work from Office

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up *Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M. Pharm (Pharmacology) with 2-6 Yrs of Relevant Experience Interested candidates c...

Posted 4 months ago

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