10 Icf Jobs

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 independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Reviews content created by peers writers. 4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned. Preferred candidate profile Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality

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-depth understanding of Data Management conventions, data standards, Processes and Drug development Process. Experience with Study convention including non-CRF collection data standards, Processes, Knowledge sharing and best practices on assigned studies. Influence Study Team to adhere non-CRF guidance, processes and negotiate contingency plans to mitigate delays of deliverables.

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 strategy. In-depth understanding of Data Management conventions, data standards, Processes and Drug development Process. Experience with Study convention including non-CRF collection data standards, Processes, Knowledge sharing and best practices on assigned studies. Influence Study Team to adhere non-CRF guidance, processes and negotiate contingency plans to mitigate delays of deliverables. Task: Lead collection of non-CRF data during Study Setup, Conduct and Closeout activities IXRS and Complex Data Models. Effectively communicate non-CRF data collection deliverable, Status of work and Data issues to the assigned study team and SME’s. Collaborate with multiple non-CRf vendors or data providers to setup Data Transfer Agreement to ensure timely and quality delivery.

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

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 functions. Ensuring that medical care is provided to a subject for any adverse event(s) that is reported. Informing a subject when medical care is needed to treat an inter-current illness. Provide information regarding adverse events and serious adverse events to the IRB/IEC. Possessing a thorough understanding of the requirements of each protocol . Ensuring recruitment goals are reasonable and attainable. Assessing overall protocol feasibility. Following the trials randomization procedures. Ensuring that the informed consent form contains the entire Essential and additional elements required. Conduct of the clinical studies specified by the applicable regulatory requirement(s), the IRB/IEC requirements and/or the regulatory authorities. Conduct the study as per the principles of ethics and is compliance with Good Clinical Practices (GCP). Attending education workshops. Reviewing professional publications. Participating in professional societies Maintaining a list of qualified persons and their corresponding trial-related delegated duties. Preferred candidate profile can send to email: hr@qpsbioserve.com or raghavendra.kundhula@qpsbioserve.com Perks and benefits: Nil

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 Administrator at Kyndryl, because no two projects are alike. You’ll be managing systems data for clients and providing day-to-day solutions and security compliance. You’ll oversee a queue of assignments and work directly with technicians, prioritizing tickets to deliver the best solutions to our clients. One of the benefits of Kyndryl is that we work with clients in a variety of industries, from banking to retail. Whether you want to broaden your knowledge base or narrow your scope and specialize in a specific sector, you can find your opportunity here. You’ll also get the chance to share your expertise by recommending modernization options, identifying new business opportunities, and cultivating relationships with other teams and stakeholders. Does the work get challenging at times? Yes! But you’ll collaborate with a diverse group of talented people and gain invaluable management and organizational skills, which will come in handy as you move forward in your career. Your future at Kyndryl Every position at Kyndryl offers a way forward to grow your career, from Junior System Administrator to Architect. We have opportunities for Cloud Hyperscalers that you won’t find anywhere else, including hands-on experience, learning opportunities, and the chance to certify in all four major platforms. One of the benefits of Kyndryl is that we work with clients in a variety of industries, from banking to retail. Whether you want to broaden your knowledge base or narrow your scope and specialize in a specific sector, you can find your opportunity here. Who You Are You’re good at what you do and possess the required experience to prove it. However, equally as important – you have a growth mindset; keen to drive your own personal and professional development. You are customer-focused – someone who prioritizes customer success in their work. And finally, you’re open and borderless – naturally inclusive in how you work with others. Required Technical and Professional Expertise • 9+ Years of Experience in Mainframe Storage Administration. • Experience with DASD and tape data storage solutions (Experience on DASD/Tape Configuration and Migration) for mainframes. • Candidate should possess working knowledge of Z/OS Operating System, z/OS(MVS) fundamentals, Storage fundamentals and Storage Devices. • Candidate will be expected to have good knowledge in the following areas: TSO, ISPF, JCL, VSAM, ISMF, JES2, Catalogs, Datasets (PS/PDS/PDSE/GDG), REXX, SAS, SDSF and Spool. • Candidate will be expected to have good knowledge & Experience in the following (: MF - Tape & DASD Management) areas: DFSMS, DFSMSHSM, DFSMSDSS, DFSMSDFP, DFSMSRMM, ICF Catalog, VSAM, IDCAMs, CA products (CA Disk, CA allocate and CA-1), FDR products, Omegamon XE or related Storage monitoring tools, ICKDSF, Space abends and SMF/Dcollect/BVIR reports. Preferred Technical and Professional Experience • Bachelor’s degree in computer science or a related field. • Provides technical support activities for a production mainframe environment of multiple LPARs, CECs, DASD and VTS controllers. • Experience in Storage box data migration (DASD to DASD and Tape to tape) and Storage replication. • Candidates have to work in customer work hours- US, Europe and Asia Pacific (weekends and holidays as on call staff). Being You Diversity is a whole lot more than what we look like or where we come from, it’s how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we’re not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you – and everyone next to you – the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That’s the Kyndryl Way. What You Can Expect With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter – wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed. Get Referred! If you know someone that works at Kyndryl, when asked ‘How Did You Hear About Us’ during the application process, select ‘Employee Referral’ and enter your contact's Kyndryl email address.

• 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 eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively • Good understanding of clinical trial and product life cycle EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc EXPERIENCE: 4 to 6 years of Regulatory Writing/Reviewing experience LOCATION: Bangalore (Office-based/Hybrid) SKILLS: • Good communication skills (Written and Oral) • MS Office (Excel and Power point) PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES: • Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects) o Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD) o Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development o Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development o Conduct quality checks to ensure the accuracy and consistency of data included in documents o Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas o Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism o Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation and technical requirements like language, grammar, style, content search, summarizing, data conflicts and referencing o Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones o Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective • Broad Area-2: Review Content of Team Members o Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact check o Guide team members on content client requirements and quality aspects of content development for different deliverables development (including but not limited to Protocols, IBs, ICF, clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD), o Guide team members to develop content outlines for different target groups that are accurate, clinically relevant, reflecting the most recent medical advances and in accordance with established content development practices, in collaboration with clients and team leads • Broad area-3: Process Adherence and Compliance o Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy o Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client o Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms o Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines • Broad Area-4: Self-Development o Support in developing technical training programs for other team members relevant to the job o Responsible to complete client-specific training, if applicable o Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas o Learn the basic skills to manage teams o Participate in and contribute to various continuous improvement initiatives or company driven initiatives Interested Candidate Please Apply - India.hr@infinitysts.com

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 a Mainframe Storage System Administrator at Kyndryl, because no two projects are alike. You’ll be managing systems data for clients and providing day-to-day solutions and security compliance. You’ll oversee a queue of assignments and work directly with technicians, prioritizing tickets to deliver the best solutions to our clients. One of the benefits of Kyndryl is that we work with clients in a variety of industries, from banking to retail. Whether you want to broaden your knowledge base or narrow your scope and specialize in a specific sector, you can find your opportunity here. You’ll also get the chance to share your expertise by recommending modernization options, identifying new business opportunities, and cultivating relationships with other teams and stakeholders. Does the work get challenging at times? Yes! But you’ll collaborate with a diverse group of talented people and gain invaluable management and organizational skills, which will come in handy as you move forward in your career. Your future at Kyndryl Every position at Kyndryl offers a way forward to grow your career, from Junior System Administrator to Architect. We have opportunities for Cloud Hyperscalers that you won’t find anywhere else, including hands-on experience, learning opportunities, and the chance to certify in all four major platforms. One of the benefits of Kyndryl is that we work with clients in a variety of industries, from banking to retail. Whether you want to broaden your knowledge base or narrow your scope and specialize in a specific sector, you can find your opportunity here. Who You Are Required Technical and Professional Expertise • 7+ Years of Experience in Mainframe Storage Administration. • Experience with DASD and tape data storage solutions (Experience on DASD/Tape Configuration and Migration) for mainframes. • Candidate should possess working knowledge of Z/OS Operating System, z/OS(MVS) fundamentals, Storage fundamentals and Storage Devices. • Candidate will be expected to have good knowledge in the following areas: TSO, ISPF, JCL, VSAM, ISMF, JES2, Catalogs, Datasets (PS/PDS/PDSE/GDG), REXX, SAS, SDSF and Spool. • Candidate will be expected to have good knowledge & Experience in the following (: MF - Tape & DASD Management) areas: DFSMS, DFSMSHSM, DFSMSDSS, DFSMSDFP, DFSMSRMM, ICF Catalog, VSAM, IDCAMs, CA products (CA Disk, CA allocate and CA-1), FDR products, Omegamon XE or related Storage monitoring tools, ICKDSF, Space abends and SMF/Dcollect/BVIR reports. Preferred Technical and Professional Experience • Bachelor’s degree in computer science or a related field. • Provides technical support activities for a production mainframe environment of multiple LPARs, CECs, DASD and VTS controllers. • Experience in Storage box data migration (DASD to DASD and Tape to tape) and Storage replication. • Candidates have to work in customer work hours- US (weekends and holidays as on call staff). Being You Diversity is a whole lot more than what we look like or where we come from, it’s how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we’re not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you – and everyone next to you – the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That’s the Kyndryl Way. What You Can Expect With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter – wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed. Get Referred! If you know someone that works at Kyndryl, when asked ‘How Did You Hear About Us’ during the application process, select ‘Employee Referral’ and enter your contact's Kyndryl email address.

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 can share their CVs on meghamaheshwari@torrentpharma.com / vilshashah@torrentpharma

Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364