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0 years
0 Lacs
India
Remote
Conduct virtual consultations with patients diagnosed with diabetes, offering medical advice, treatment plans, and lifestyle recommendations. Diagnose and evaluate patients with diabetes, including Type 1, Type 2, Gestational diabetes, and other related conditions. Review patients' medical histories, laboratory test results, and other relevant information to assess their condition and develop personalised care plans. Educate patients and their care-givers on diabetes self-management techniques, including medication adherence, blood glucose monitoring, diet, exercise, and stress management. Utilise digital health technologies and our platform's tools to communicate with patients, track their progress, and update medical records. Collaborate with a multidisciplinary team, including diabetes educators and coaches, to provide comprehensive diabetes care. Stay updated on the latest advancements in diabetes management, research, and treatment options. Adhere to professional standards, medical ethics, and relevant regulations governing telemedicine practice. Maintain patient confidentiality and ensure data privacy and security in accordance with MoHFW and Niti Aayog guidelines. Provide exceptional patient care, fostering trust, empathy, and effective communication in virtual consultations. Participate in regular team meetings, continuing education activities, and professional development opportunities. Participate in quality improvement initiatives, research projects, clinical studies, and educational activities to enhance diabetes care within the company. Develop training curriculum, training material, presentation for the health coaches. Deliver training sessions, provide guidance and support to the health coaches. Skills & Experience: Proficiency in both Tamil and Malayalam languages is mandatory for this role. MBBS degree from a medical college recognised by the Govt. of India and NMC. Postgraduate medical degree (MD or equivalent) from an accredited institution recognised by NMC and Govt of India. CCEBDM Certification is an additional to the role. Board certification or specialisation in endocrinology or diabetes management is preferred. Valid medical registration certificate to practise in India. Professional Indemnity Insurance valid for medical practice in India. Proven experience in diagnosing and managing diabetes in a clinical setting. Familiarity with telemedicine platforms, virtual consultation tools, and electronic health record (EHR) systems. Strong knowledge of current diabetes guidelines, treatment protocols, and emerging trends in diabetes care. Excellent verbal and written communication skills, with the ability to explain complex medical concepts in a clear and understandable manner. Strong interpersonal skills to establish rapport and build trust with patients remotely. Ability to work independently, make informed clinical decisions, and manage time effectively. Must have prior experience in consulting the diabetes patient. Commitment to maintaining the highest standards of patient care, professionalism, and ethical conduct. Demonstrated passion for improving diabetes management and patient outcomes. Commitment to continuous professional development and staying abreast of advancements in the field of diabetes management. Show more Show less
Posted 14 hours ago
0 years
0 Lacs
Gurugram, Haryana, India
On-site
Company Description BabyBloom IVF & Maternity Centre is a leading fertility clinic in Gurgaon and Rohtak, India, offering a comprehensive range of fertility treatments such as IVF, IUI, and egg donation. The centre specializes in helping couples with low egg or sperm count achieve successful pregnancies without the need for donors. They are known for their transparency, respect for religious sentiments, and high success rates in fertility treatments. Role Description This is a full-time on-site role for a Senior IVF Counselor at BabyBloom IVF & Maternity Centre in Gurugram. The Senior IVF Counselor will be responsible for providing counseling and support to couples undergoing fertility treatments, explaining procedures, discussing options, and guiding patients through the emotional aspects of the process. Qualifications Counseling skills, empathy, and compassion Knowledge of fertility treatments such as IVF, IUI, and surrogacy Experience in providing emotional support to patients undergoing fertility treatments Excellent communication and interpersonal skills Ability to work in a fast-paced and sensitive environment Previous experience in reproductive endocrinology or infertility counseling is a plus Master's degree in Counseling, Psychology, Social Work, or related field Show more Show less
Posted 18 hours ago
36.0 years
0 Lacs
Delhi, India
On-site
Selected Intern's Day-to-day Responsibilities Include Manage patient care and treatment Supervise and coordinate staff activities Ensure hygiene standards and cleanliness management About Company: Jyoti Nursing Home (Hospital & clinic) is the name of a Trust, Compassion, and quality medical care, committed to providing the best possible patient care for 36 years. Being patient-centric means providing the latest in medical technology, with procedures that are most comfortable and have the best outcomes. Rising above with passing time, we are soon becoming a recognized name in medical care in the state. Due to its advanced perfection and high quality of work, it has now established itself as one of the best hospitals in East Delhi, Shahdara. Specializes in psychiatric consultation, dermatology, neurology, nephrology, hepatology, endocrinology (thyroid & diabetes), cardiology, gynecology, and orthopedic surgeries. Show more Show less
Posted 2 days ago
0 years
1 - 6 Lacs
Jamshedpur
On-site
Role description Should be a competent doctor Should be able to diagnosis and examine the patients properly, manage them and do proper consultations. Skills Evaluate patients to diagnose endocrine disorders Create and implement treatment plans for patients with endocrine disorders Conduct diagnostic tests, including blood tests and imaging studies, to assess hormone levels and gland function Interpret test results and diagnose endocrine disorders Develop and implement preventive care plans to help patients manage and reduce the risk of endocrine disorders Consult with other healthcare professionals, including primary care physicians and surgeons, to coordinate patient care Educate patients and their families about endocrine disorders, treatment options, and lifestyle changes to promote endocrine health Provide follow-up care to monitor patients' progress and adjust treatment plans as necessary Document patient information and treatment plans in patient medical records Other details Should have qualified MBBS from a recognized institute. Should have DNB/MD in Endocrinology. The institute should be NMC/MCI registered.
Posted 2 days ago
3.0 - 9.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Azurity is seeking an experienced in-house counsel to support its Global Operations, Supply Chain & Alliance Management Function with legal responsibilities which include contracts, legal documentation, strategizing, and advisory. The candidate must be experienced in understanding pharmaceutical business, processes and transactions, and be involved in taking strategic decisions and providing legal guidance related to manufacturing, supply and ancillary services, handling cross-border contracts, dealing with internal stakeholders and counterparties globally, well versed managing Contract Life Cycle Management tools, and should have strong experience. Duties And Responsibilities Stakeholder Management Serve as a strong Legal Business Partner for the relevant departments. Gain a deep understanding of the business, products, strategies, transactions, and various issues by aligning with the relevant departments. Regularly attend meetings, proactively identify legal issues and highlight risks, and provide solutions to mitigate by collaborating with the relevant departments. Ensure all legal requirements are completed within stipulated timelines to facilitate smooth transactions for the relevant departments. Preemptively track all important dates and events, and take actions accordingly. Work closely with India General Counsel and other legal team members. Contracts Draft, review and negotiate wide range of pharma contracts (domestic as well as cross border) such as Manufacturing and Supply Agreement, CDMO and CMO Agreements, Development and Supply Agreement, Technology Transfer Agreements, API Supply Agreements, Master Service Agreement, Quality Agreement, Pharmacovigilance Agreement, Scope of Work, Product Addendums, Consulting Agreements, etc. Ensure that the agreements drafted and negotiated as per company’s playbook and are executed in timely manner. Ensure risk mitigation, protection of intellectual properties, and commercial interests of the organization by way of contracts. Inform and guide stakeholders on the interpretation and purposes of contracts related provisions. Identify and assist stakeholders with resolution of issues affecting completion of Agreements. Format documents for finalization. Manage the legal contracts folder. Gather, quantify, and report on legal department metrics. Contract Lifecycle Management Platform As a highly system-driven organization, Azurity has implemented and uses a contract lifecycle management software / tool, namely Ironclad Manage and oversee Azurity’s contract life cycle using Ironclad, ensuring contracts are properly tracked, stored and managed. Support the creation of contracts by gathering and vetting required inputs, including business terms from business and functional owners. Guide internal clients through the contract request process. As intake coordinator, review contract requests and statements of work against Perform review of expiring contracts and manage renewals and amendments. Be experienced and well versed with contract management software / tools – similar to Ironclad (if not better) Provide advice and support to various departments on matters related to contracts as well as Ironclad. Align with legal, finance and business team members to ensure that Ironclad is used in the most efficient manner Develop and implement (or assist to) procedures to improve the efficacy of Ironclad Act as liaison between internal clients and the legal department for timely processing of contracts. Handle status inquires, process questions, and direct inquiries to the appropriate attorney. Metadata abstraction and tagging into the Contract Lifecycle Management Tool – Ironclad. Co-ordinating with stakeholders for execution through Docusign. General Duties Conduct legal issue identification, investigate factual issues, and analysis and legal risk assessment. Interpret and respond to requests for information, documents, and status-up-dates-from colleagues seeking legal support. Preparing various reports and presentations. Provide support in transactional due diligence. Perform special projects and general support for the Legal Department. Any other duties as may be entrusted from time to time Qualifications LL.B from a reputed university 3-9 years of related experience, preferably with at least 3 years in-house pharma legal experience; Minimum of 3 years of applicable experience on contract life cycle management tool; Experience of supporting in-house legal department; Basic understanding of pharmaceutical industry – development, technology transfer, supply and manufacturing, contract manufacturing, API Supply, Clinical Trails, Licensing, etc., Highly skilled in Microsoft Office suite; experience in DocuSign and Box.com preferred; Strong verbal and written communications skills to enable communication with legal colleagues and stakeholders present globally, particularly in the US, Ireland, and other EU countries. Ability to consistently solve problems with a high degree of independent decision-making Strong organizational skills with careful attention to detail. Strong interpersonal skills and must be highly team oriented. High level of professionalism and ability to maintain absolute confidentiality. Ability to build business acumen and understand core elements of the applicable business area. Ability to handle multiple complex tasks and high volume of work in a team-based environment and consistently meet deadlines. General tech savvy and able to learn new skills necessary to keep pace with an ever-changing landscape. Benefits We recognize hard work and dedication with benefits offerings that address individual needs. Our comprehensive package of benefits for eligible employees includes the following: For a list of benefits, please see our benefits listing on our careers page at www.azurity.com/careers/ By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 2 days ago
3.0 years
0 Lacs
Navi Mumbai, Maharashtra, India
On-site
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Engineer to join our Information Technology team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities Utilize skills in development areas including data warehousing, business intelligence, and databases (Snowflake, ANSI SQL, SQL Server, T-SQL); Support programming/software development using Extract, Transform, and Load (ETL) and Extract, Load and Transform (ELT) tools, (dbt, Azure Data Factory, SSIS); Design, develop, enhance and support business intelligence systems primarily using Microsoft Power BI; Collect, analyze and document user requirements; Participate in software validation process through development, review, and/or execution of test plan/cases/scripts; Create software applications by following software development lifecycle process, which includes requirements gathering, design, development, testing, release, and maintenance; Communicate with team members regarding projects, development, tools, and procedures; and Provide end-user support including setup, installation, and maintenance for applications Qualifications Bachelor's Degree in Computer Science, Data Science, or a related field; 3+ years of experience in Data Engineering; Knowledge of developing dimensional data models and awareness of the advantages and limitations of Star Schema and Snowflake schema designs; Solid ETL development, reporting knowledge based off intricate understanding of business process and measures; Knowledge of Snowflake cloud data warehouse, Fivetran data integration and dbt transformations is preferred; Knowledge of Python is preferred; Knowledge of REST API; Basic knowledge of SQL Server databases is required; Knowledge of C#, Azure development is a bonus; and Excellent analytical, written and oral communication skills. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. Show more Show less
Posted 3 days ago
0 years
0 Lacs
Jamshedpur, Jharkhand, India
On-site
Role description Should be a competent doctor Should be able to diagnosis and examine the patients properly, manage them and do proper consultations. Other details Should have qualified MBBS from a recognized institute. Should have DNB/MD in Endocrinology. The institute should be NMC/MCI registered. Show more Show less
Posted 3 days ago
6.0 - 9.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description Our Formulation R&D team at Azurity lend Scientific Expertise and diligence to the program/s. Manage timelines and product deliverables. Develops unique product formulations / platforms that meet the specifications of TPPs in providing innovative, high-quality medicines that serve overlooked patients. We have an exciting opportunity— the person we select for this role will play a key part in Azurity’s scientific excellence, contribution to patient care and growth of business. Role Title: Assistant Manager /Dy. Manager, Formulation R&D (Experience: 6 to 9 years) Role Reports to: Tech Lead and Delivery Captain Principle Responsibilities Perform formulation development activities on differentiated formulations and innovative technologies to achieve Product development with adherence to timelines while ensuring good lab and documentation practices. Carry out /Support Scientific literature search (Articles/patents/publications/books) and compilation of experimental data, which will facilitate decision making to achieve Product development. Support drug product ideation and selection activities with technical due diligence with appropriate development approaches and assessing timelines. Perform Formulation optimization with special focus on manufacturability and biopharmaceutical properties of drug products to achieve successful commercial drug product. Carryout & Support Writing and Review of protocols, reports, validation plans and development report to achieve product development in compliance with quality systems. Coordinate with CFT’s and timely escalation to ensure document approvals on time. Coordination with the cross functional teams (CFTs) like Analytical Development, Quality Assurance, Regulatory Affairs, etc. Support in preparing formal correspondence with regulatory agency to get clarity for focused efforts. Prepare and review Standard Operating Procedures (SOPs), Technology Transfer Document (TTD), and other technology transfer related documents. Ensure the activities are carried out in compliance with various quality, regulatory and EHS norms. Support and coordinate application of various regulatory licenses required for R&D, clinical, import activities. Ensure timely availability of such licenses. Support in Developing, maintaining, and upgrading lab facility and support facility team to maintain and run lab effectively. Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities. Travel Required Qualifications And Education Requirements This section should include relevant qualifications and education requirements. Pharm in Pharmacy with minimum industrial experience of 6 to 9 years in pharmaceutical formulation development. Preferred area of expertise is Immediate Release/Modified Release/Controlled release/ Solid Oral Dosage forms (Tablets/Capsules/ODT/PFOS/Granules/MUPS) and/or Immediate Release Oral Suspensions/Solutions. Preferred area of expertise in handling complex and super complex dosage forms. Global Product Development Experience is preferred while the core area should be the US. Experience of developing branded and differentiated products – 505(b)(2) category would be preferred. Should be well versed with Microsoft office applications. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 4 days ago
0.0 - 3.0 years
2 - 5 Lacs
Malappuram
Work from Office
Dr. Medcare is looking for Senior Specialist - Endocrinology to join our dynamic team and embark on a rewarding career journey. As a Specialist in Endocrinology, you will specialize in the diagnosis, treatment, and management of endocrine disorders. Your role involves providing expert medical care to patients with conditions affecting the endocrine system, including diabetes, thyroid disorders, and hormonal imbalances. This position requires clinical expertise, a commitment to patient care, and collaboration with a multidisciplinary healthcare team. Key Responsibilities : Patient Care : Conduct comprehensive assessments and examinations of patients with endocrine disorders. Develop and implement individualized treatment plans based on diagnoses. Diagnostic Procedures : Order and interpret diagnostic tests, including blood tests, imaging, and hormonal assays. Utilize specialized procedures such as ultrasound or fine - needle aspiration when required. Diabetes Management : Manage patients with diabetes, including type 1 and type 2 diabetes mellitus. Provide education on self - management, insulin therapy, and lifestyle modifications. Thyroid Disorders : Diagnose and manage thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroid nodules. Perform and interpret thyroid function tests. Hormonal Imbalances : Evaluate and treat hormonal imbalances affecting the adrenal glands, pituitary gland, and reproductive organs. Manage conditions such as polycystic ovary syndrome (PCOS) and hirsutism. Osteoporosis and Metabolic Bone Diseases : Assess and manage conditions related to bone health, such as osteoporosis. Provide guidance on nutritional support and lifestyle modifications. Collaboration with Healthcare Team : Work collaboratively with nurses, dietitians, pharmacists, and other healthcare professionals. Participate in multidisciplinary rounds and case discussions. Patient Education : Educate patients and their families on endocrine conditions, treatment options, and preventive measures. Promote health and wellness through lifestyle modifications. Research and Continuous Learning : Stay updated on advancements in endocrinology through research and continuing medical education. Contribute to clinical research in the field. Documentation : Maintain accurate and detailed medical records for all patient encounters. Ensure compliance with documentation standards and regulatory requirements.
Posted 4 days ago
3.0 years
0 Lacs
Hyderabad, Telangana, India
Remote
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description Our Digital team at Azurity is building new capabilities utilizing cutting-edge Salesforce systems. We are looking for a dynamic, change inspired, Individual self-driven hands-on Team Member. The Salesforce Developer – Life Sciences is responsible for designing, developing, and optimizing Salesforce solutions to support Azurity pharma. This role focuses on customizing Salesforce platform ensuring seamless HCP/HCO engagement, sales rep support, regulatory compliance, and commercial operations. The ideal candidate will collaborate with onshore architects, business analysts, and stakeholders to develop scalable, high-performing Salesforce solutions while maintaining compliance with HIPAA, GDPR, Sunshine Act, and FDA regulations. Principle Responsibilities Salesforce Development & Customization Develop and enhance Life Sciences-specific CRM functionalities in Salesforce platform and Sales Cloud to support HCP/HCO engagement, Commercial Operations, KOL (Key Opinion Leader) management, and field rep journeys. Customize Salesforce objects, Apex triggers, Lightning Web Components (LWC), Visualforce pages, and declarative automation (Flows, Process Builder). Implement consent tracking, call planning, sample management, and omnichannel engagement workflows for field reps, MSLs (Medical Science Liaisons), and sales teams. Ensure territory management, commercial operations, and compliance tracking are seamlessly integrated into Salesforce. Performance Optimization & Security Optimize Apex code, SOQL queries, and Lightning Web Components for scalability and high performance. Implement role-based security, audit logs, and field-level encryption to maintain compliance with HIPAA, GDPR, and FDA regulations. Conduct code reviews, unit testing, and debugging to ensure high-quality solution delivery. Collaboration & Agile Development Work closely with onshore architects, business analysts, and product owners to gather requirements and translate them into technical solutions. Participate in scrum meetings, sprint planning, and UAT (User Acceptance Testing) as part of an Agile team. Provide technical documentation and deployment support for Salesforce enhancements. Continuous Improvement & Best Practices Stay updated with Salesforce releases, Life Sciences Cloud advancements, and best practices. Implement Salesforce DevOps methodologies, using tools like Gearset, Copado, Jenkins for CI/CD automation. Preferred Skills And Experience 3+ years of experience in Salesforce development, preferably in Life Sciences or Healthcare. Expertise in Salesforce Health Cloud, Sales Cloud, or Veeva CRM Proficiency in Apex, Lightning Web Components (LWC), Visualforce, SOQL, and API development. Hands-on experience with Salesforce APIs (REST, SOAP), middleware tools (MuleSoft, Informatica, Boomi), and data migration. Hands-on experience with Salesforce DevOps tools (Gearset, Copado, Jenkins) for release management. Understanding of HIPAA, GDPR, Sunshine Act, FDA regulations, and data security best practices. Experience working in a global offshore-onshore collaboration model using Agile methodologies. Salesforce Platform Developer I & II certifications required. Excellent problem-solving and communication skills in a remote, global team setup. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 4 days ago
10.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description Our Digital team at Azurity is building new capabilities utilizing cutting-edge Lead IT Systems (R, Q & RIMS) Expert. We are looking for a dynamic, change inspired, Dwell b/w multiple system, Individual self-driven hands-on Lead IT Systems (R, Q & RIMS) Expert. Team Member Ability to work onsite during flexible hours to support India, US and EU operations Job Summary We are seeking a dynamic and versatile Lead IT Systems with strong hands-on experience in Research, Quality Management Systems (QMS) and Document Management Systems (DMS), coupled with a working knowledge of RIMS and Lab Systems. This role requires the ability to wear multiple hats, supporting a cross-functional pharma IT landscape that spans Quality, Regulatory, and Laboratory systems. The ideal candidate thrives in a regulated environment, collaborates across functions, and ensures systems remain compliant, validated, and business aligned. Mandatory Qualifications B.Tech / B.E. in Computer Engineering (Mandatory) M.Tech in Computer Engineering / IT (Preferred) Experience Required 8–10+ years in IT within the pharmaceutical industry Deep hands-on experience with TrackWise, Veeva Vault QMS/DMS, AmpleLogic QMS, and exposure to RIMS and Lab Systems Expertise in CSV, GxP compliance, 21 CFR Part 11, and audit preparedness Strong involvement in data migration activities and end-user training Soft Skills (Mandatory) Strong verbal and written communication Effective cross-functional collaboration (Quality, Regulatory, Lab, IT) Growth mindset with ability to handle evolving platforms Product roadmap alignment and stakeholder influence Ability to navigate complexity and ambiguity in stakeholder conversations “Multiple Hats" mindset – flexibility to contribute across QMS, DMS, RIMS, and Lab Systems as needed Ability to confidently demonstrate system functionalities and conduct user workshops Role Distribution System Domain Focus Role Expectation QMS / DMS 70% Lead ownership of workflows, validation, support, and vendor management (Veeva Vault, TrackWise, AmpleLogic), Other evolving System RIMS 20% Support submission tracking, registration workflows, and regulatory readiness Lab Systems 10% Basic support for LIMS, MPower, instrument data integrity Responsibilities Quality Systems (70%) –Core Hands-On Ownership Configure and manage QMS/DMS platforms (TrackWise, Veeva Vault QMS/DMS, AmpleLogic), Other evolving Systems Design and optimize CAPA, Change Control, Audit, Deviation, and Document Lifecycle workflows Execute and manage CSV lifecycle – URS, IQ/OQ/PQ, RTM Provide L2/L3 support, user training, SOP documentation, and handle audit readiness Coordinate directly with vendors for system updates, patching, and roadmap discussions Lead and execute data migration activities with validation and reconciliation Demonstrate QMS/DMS systems confidently to users and auditors Regulatory Systems (20%) – Supportive Ownership Administer Veeva Vault RIM or equivalent RIMS platforms Manage registration tracking, submission workflows, and HA interactions Collaborate with RA teams to gather requirements, support compliance, and maintain inspection readiness Lab Systems (10%) – Tactical Support Support AmpleLogic LIMS and MPower QC systems Monitor instrument integration and data flow (HPLC, GC, FTIR) Address sample tracking issues and logbook automation enhancements Technical Skill Set Platform Expertise Level Hands-On Scope TrackWise QMS Expert CAPA, Deviation, Audit, Change Control Veeva Vault (QMS/DMS/RIM) Expert CAPA, Deviation, Audit, Change Control Controlled docs, QMS workflows, RIMS lifecycle AmpleLogic QMS/LIMS Expert Stability, sample tracking, electronic forms MPower (QC Systems) Proficient Batch/lab workflows CSV / Validation Expert GAMP 5, ALCOA+, 21 CFR Part 11 RIMS (e.g., Veeva RIM) Proficient Submission lifecycle tracking Data Migration Proficient Legacy to new platform migration, reconciliation Training & Demos Proficient Conducting user workshops, confident system walkthroughs Audit Readiness Expert System readiness, evidence generation Service Tools Proficient JIRA, ServiceNow Instrument Integration Intermediate Empower, Agilent, OpenLab Team Member is expected to wear multiple hats—flexibly contributing to QMS/DMS ownership, RIMS support, and Lab systems troubleshooting as business needs evolve. Agility, accountability, and collaboration are key to success in this hybrid role. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 4 days ago
30.0 years
0 Lacs
Navi Mumbai, Maharashtra, India
On-site
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. Show more Show less
Posted 4 days ago
3.0 - 9.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Azurity is seeking an experienced in-house counsel to support its Global Infrastructure Function, which includes Finance, IT / Digital, Work Place Services, HR, EPMO, etc. The legal responsibilities for this role include statutory compliance (for the Indian entity), contracts, legal documentation, strategizing, and advisory. The candidate must be experienced in understanding and working on the legal requirements for Finance, IT/Digital, Workplace Services, HR, and EPMO departments within an organization. They should have expertise in cross-border contracts, dealing with internal stakeholders and counterparties globally, and be well-versed in managing Contract Lifecycle Management Platform. Additionally, the candidate should have strong experience in stakeholder management and communication to effectively coordinate with various stakeholders present globally. Duties And Responsibilities Stakeholder Management Serve as a strong Legal Business Partner for the relevant departments. Gain a deep understanding of the business, products, strategies, transactions, and various issues by aligning with the relevant departments. Regularly attend meetings, proactively identify legal issues and highlight risks, and provide solutions to mitigate by collaborating with the relevant departments. Ensure all legal requirements are completed within stipulated timelines to facilitate smooth transactions for the relevant departments. Preemptively track all important dates and events, and take actions accordingly. Work closely with India General Counsel and other legal team members. Contracts Draft, review and negotiate contracts (domestic as well as cross border) such as Service Agreements, SaaS Agreements, Consulting Agreements Subscription Agreements, Lease Agreements, Engagement Letters, Offer Letters, Employment Agreements, Scope of Work, Change Orders, Purchase Orders / Terms and Conditions etc., and amendments, addendum, assignment and termination thereof. Developing playbook /checklist for the frequently used contracts and ensuring that the agreements are drafted and negotiated as per the playbook / checklist and are executed in timely manner. Ensure risk mitigation, protection of intellectual properties, and commercial interests of the organization by way of contracts. Inform and guide stakeholders on the interpretation and purposes of contracts related provisions. Identify and assist stakeholders with resolution of issues affecting completion of contracts.. Format documents for finalization. Manage the legal contracts folders. Gather, quantify, and report on legal department metrics. Contract Lifecycle Management Platform As a highly system-driven organization, Azurity has implemented and uses a Contract Lifecycle Management Platform, namely Ironclad Manage and oversee Azurity’s contract life cycle using Ironclad, ensuring contracts are properly tracked, stored and managed. Support the creation of contracts by gathering and vetting required inputs, including business terms from business and functional owners. Guide internal clients through the contract request process. As intake coordinator, review contract requests and statements of work against Perform review of expiring contracts and manage renewals and amendments. Be experienced and well versed with Contract Management Platform – similar to Ironclad (if not better) Provide advice and support to various departments on matters related to contracts as well as Ironclad. Align with legal, finance and business team members to ensure that Ironclad is used in the most efficient manner Develop and implement (or assist to) procedures to improve the efficacy of Ironclad Act as liaison between internal clients and the legal department for timely processing of contracts. Handle status inquires, process questions, and direct inquiries to the appropriate attorney. Metadata abstraction and tagging into the Contract Lifecycle Management Platform – Ironclad. Co-ordinating with stakeholders for execution through Docusign. General Duties Conduct legal issue identification, investigate factual issues, and analysis and legal risk assessment. Interpret and respond to requests for information, documents, and status-up-dates-from colleagues seeking legal support. Preparing various reports and presentations. Provide support in transactional due diligence. Perform special projects and general support for the Legal Department. Any other duties as may be entrusted from time to time Qualifications LL.B from a reputed university 3-9 years of relevant experience; Experience of supporting in-house legal department; Highly skilled in Microsoft Office suite; experience in DocuSign and Box.com preferred; Strong verbal and written communications skills to enable communication with legal colleagues and stakeholders present globally, particularly in the US, Ireland, and other EU countries. Ability to consistently solve problems with a high degree of independent decision-making. Strong organizational skills with careful attention to detail. Strong interpersonal skills and must be highly team oriented. High level of professionalism and ability to maintain absolute confidentiality. Ability to build business acumen and understand core elements of the applicable business area. Ability to handle multiple complex tasks and high volume of work in a team-based environment and consistently meet deadlines. Tech savvy and able to learn new skills necessary to keep pace with an ever-changing landscape. Benefits We recognize hard work and dedication with benefits offerings that address individual needs. Our comprehensive package of benefits for eligible employees includes the following: For a list of benefits, please see our benefits listing on our careers page at www.azurity.com/careers/ By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 5 days ago
5.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Strategic Responsibilities Life Cycle Management: Lead the life cycle of existing brands and newly launched products, crafting and executing growth plans that propel our business forward. Strategy Development: Develop a visionary strategy roadmap for our rare disease portfolio, increasing our business impact and solidifying our position as industry leaders. Brand Plan Execution: Drive brand plans and spearhead multi-channel marketing initiatives, leveraging customer insights to create compelling campaigns. Analytics Utilization: Harness the power of analytics to assess business trends, deploy growth strategies, and mitigate risks. Financial Accountability: Oversee the financial aspects of our brands, including revenue, promotional budgets, and profitability. Stakeholder Identification: Identify and engage key stakeholders to expand our business opportunities and develop strategic partnerships. New Product Launch Responsibilities Business Opportunity Identification: Discover new business opportunities and develop proposals that capitalize on current market trends and therapy area landscapes. Strategy and Execution: Prepare and execute strategies that address unmet needs in the therapy area, ensuring successful product launches. Stakeholder Collaboration: Collaborate with internal and external stakeholders to develop and implement new product launch strategies. Capability Building: Identify and address the needs of stakeholders, developing strategies with measurable outcomes to enhance their capabilities. Operational Responsibilities Implementation Plan: Define and implement brand strategies, monitor SLAs with stakeholders to ensure seamless execution. Marketing Campaigns: Design creative marketing campaigns, cascade them to target customers, and train the sales force to maximize impact. External Liaison: Partner with external agencies to deliver brand initiatives that resonate with our audience. Performance Monitoring: Utilize tools to monitor business performance and the external environment, taking corrective actions as needed. Budget Utilization: Strategically plan and allocate marketing budgets to maximize return on investment. Sales Team Support: Provide timely insights to the sales team, ensuring brand health and achieving market share, sales, and profit objectives. Scientific Relationships: Foster and maintain scientific relationships with KOLs, medical societies, government institutes, and centers of excellence. Field Visits: Conduct regular field visits to gather customer insights and ensure the effective implementation of marketing plans. Compliance Responsibilities Process Compliance: Ensure adherence to Pfizer policies and industry guidelines in the execution of brand strategies. Content Validation: Collaborate with the Medical and Marketing teams to validate content. Risk Assessment: Perform periodic risk assessments and define mitigation plans for programs and campaigns. Regulatory Adherence: Comply with regulatory guidelines while designing brand campaigns. Basic Qualifications MBA in Marketing Over 5 years of experience in Brand/Product management, preferably in Rare Diseases, Endocrinology, or other specialized innovative therapy areas. Strong understanding of the Indian healthcare market and pharmaceutical industry. Experience working with government stakeholders and key business decision-makers. Proven track record in endocrine, hematology, hemophilia, and bleeding disorders. Ability to work in a matrix organization and develop structured project plans. Commitment to the highest ethical standards. Expertise in multi-channel marketing and stakeholder engagement. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Marketing and Market Research Show more Show less
Posted 5 days ago
1.0 years
0 Lacs
Navi Mumbai, Maharashtra, India
On-site
Due to our continued growth, we are in need of qualified and focused individuals, like yourself. This is a vital role with our Clinical Safety team whose success relies upon your finely tuned skills and background. If you are ready to make a difference, you must be able to accomplish these tasks: Responsibilities Implementation of routine system configuration including product, study and license in Argus and Argus J; Assist with creating reports using Oracle Business Intelligence reporting tool; Resolve safety database-related issues; Prepare/Execute User Acceptance Testing (UAT) of safety system changes; Assist in Argus Database Training for new users, as applicable; Generate outputs from the global safety system in support of periodic safety reports (e.g. DSUR, PSUR and PBRER) ; Assist in the development of system support related process, SOPs, Work Instructions and manuals and Support Inspection and Audits. Qualifications Bachelor’s Degree in scientific discipline or Business Informatics or similar area with 1-2 years of directly related experience; Preferred Qualifications: Work experience in CRO/biotech/pharmaceutical industry. Experience in Study configurations in Safety Systems. Experience with Safety Database preferably Argus and Argus J. Experience in SQL. Experience in reporting and analytic platforms such as OBIEE. Strong client service orientation. Strong consultative problem-solving skills. Ability to combine technical problem-solving skills with discernment to resolve best business solution. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. Show more Show less
Posted 6 days ago
2.0 - 6.0 years
8 - 11 Lacs
Navi Mumbai
Work from Office
Title Our imaging services are growing rapidly, and we are currently seeking a full-time, office-based Imaging Technologist – MRI or Nuclear Medicine to join our team in Mumbai, India. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform quality assurance checks on medical imaging data to ensure protocol specific requirements are met; Perform established image processing techniques (converting imaging formats, performing preliminary measurements of lesions and volumes) across MRI or Nuclear medicine imaging modalities using proprietary software as well as other third party software; Compile and maintain project-specific status reports and project timelines associated with imaging studies; and Perform project specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocols. Qualifications Bachelor’s Degree and graduate of an accredited school of Radiologic Technology or echocardiography program. ARRT-R preferred; PET/CT, CNMT (Certified Nuclear Medicine Technologist) or ARRT - R certification preferred; 1-3 years of experience in clinical research or imaging related field, and at least 2 years of experience as an Imaging Technologist in a hospital or imaging center; and Experience working with clinical trials or within the pharmaceutical environment is preferred. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 6 days ago
4.0 - 8.0 years
6 - 15 Lacs
Navi Mumbai
Work from Office
Title We are currently seeking an full time office based Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India Mumbai. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least 4 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 6 days ago
2.0 - 6.0 years
4 - 9 Lacs
Navi Mumbai
Work from Office
Title Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based IRT Validator to join our Randomization and Study Product Management team in Mumbai, India. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Creation of test plans; Execution of test plans and creation of validation packages; Review of validation packages created by other team members; Review requirement specification documents provided by internal clients; Validation of new projects and changes to existing projects; Qualifications Bachelor’s degree in Math, Computer Science, or related field required; Demonstrated ability to complete validation tasks within defined time frames and to appropriate quality levels; Fluent in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 6 days ago
3.0 - 7.0 years
6 - 15 Lacs
Navi Mumbai
Work from Office
Title We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Posted 6 days ago
5.0 - 8.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description We have an exciting opportunity—the person we select for this role will play a key part in Azurity’s digital transformation! We are in the building phase of growing our digital to meet the future growth of the organization. This is a hands-on role and the expectation is that the incumbents will on occasion need to roll up the sleeves and take matters in their own hands. Principle Responsibilities Serves as an escalation point for application support and troubleshooting, provides guidance and direction in resolution of escalated issues and/or complex production, application or system problems Manage the tools like Active Directory, IAM, Intune, Defender etc. Manage Azure Cloud Infrastructure. Own Root Cause Analysis and Problem Management for corporate Identity Management environment (Entra) Perform daily system monitoring, verifying the integrity and availability of all Systems, hardware, server resources, systems and key processes, reviewing system and application logs, and verifying completion of scheduled jobs Create and maintain system documentation for domain technologies, including installation, configuration, and appropriate troubleshooting steps Improve existing processes through solutions to recurring problems and enhancements to existing solutions or documentation Manage customer satisfaction through effectively communicating and managing customer expectations Strong understanding of M365 components and licensing models. Automate the mundane tasks using PowerShell, Shell Scripts, Python etc. Qualifications And Education Requirements Bachelor’s Degree (accredited school) or equivalent with emphasis in computer/information science or information technology 5 - 8 years of experience in IT infrastructure Able to work in project teams, under pressure, facilitate discussion, decision-making and conflict resolution. Excellent communicator, able to engage and effectively respond to diverse stakeholders Willingness to participate in on call Fluent in English Preferred Skills And Experience Very strong working knowledge of Microsoft tech stack - Microsoft Active Directory (AD), Azure AD, IAM, DNS, DHCP, Intune, Defender, Entra ID etc. Work experience with Microsoft Azure Cloud. Comprehensive experience with enterprise multi-forest infrastructure models Building servers and virtual machines in compliance with established practice. Extensive knowledge of client / server operating systems (Linux, UNIX, and Windows), backend infrastructure services and networking, Group Policy Objects (GPOs), certificates, and their impact on Active Directory Experience on Microsoft Hyper-V and backup systems Knowledge of Identity and Access Management (IAM), authentication and authorization in particular By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 6 days ago
5.0 - 8.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description We have an exciting opportunity—the person we select for this role will play a key part in Azurity’s digital transformation! We are in the building phase of growing our digital to meet the future growth of the organization. This is a hands-on role and the expectation is that the incumbents will on occasion need to roll up the sleeves and take matters in their own hands. Principle Responsibilities Serves as an escalation point for application support and troubleshooting, provides guidance and direction in resolution of escalated issues and/or complex production, application or system problems Manage the tools like Active Directory, IAM, Intune, Defender etc. Manage Azure Cloud Infrastructure. Own Root Cause Analysis and Problem Management for corporate Identity Management environment (Entra) Perform daily system monitoring, verifying the integrity and availability of all Systems, hardware, server resources, systems and key processes, reviewing system and application logs, and verifying completion of scheduled jobs Create and maintain system documentation for domain technologies, including installation, configuration, and appropriate troubleshooting steps Improve existing processes through solutions to recurring problems and enhancements to existing solutions or documentation Manage customer satisfaction through effectively communicating and managing customer expectations Strong understanding of M365 components and licensing models. Automate the mundane tasks using PowerShell, Shell Scripts, Python etc. Qualifications And Education Requirements Bachelor’s Degree (accredited school) or equivalent with emphasis in computer/information science or information technology 5 - 8 years of experience in IT infrastructure Able to work in project teams, under pressure, facilitate discussion, decision-making and conflict resolution. Excellent communicator, able to engage and effectively respond to diverse stakeholders Willingness to participate in on call Fluent in English Preferred Skills And Experience Very strong working knowledge of Microsoft tech stack - Microsoft Active Directory (AD), Azure AD, IAM, DNS, DHCP, Intune, Defender, Entra ID etc. Work experience with Microsoft Azure Cloud. Comprehensive experience with enterprise multi-forest infrastructure models Building servers and virtual machines in compliance with established practice. Extensive knowledge of client / server operating systems (Linux, UNIX, and Windows), backend infrastructure services and networking, Group Policy Objects (GPOs), certificates, and their impact on Active Directory Experience on Microsoft Hyper-V and backup systems Knowledge of Identity and Access Management (IAM), authentication and authorization in particular By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 6 days ago
10.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description The Director of R&D Quality Assurance (QA) will be responsible for leading and managing QA oversight across multiple critical R&D functions. This includes Quality Control for R&D, equipment qualification, internal method transfer to CMOs and between CMOs for validation and registration, stability program oversight, and investigations of Out-of-Specification and Out-of-Trend results. The role ensures that quality systems and activities align with regulatory expectations (FDA, EMA, ICH, etc.) and internal standards, supporting product development and successful regulatory submissions. Principle Responsibilities Provide strategic and operational QA oversight for R&D Quality Control laboratories, ensuring compliance with cGMP and GLP regulations. Lead QA review and approval of method validation/transfer protocols and reports for methods transitioning from internal R&D to CMOs for registration and validation purposes, and between CMOs as part of horizontal Tech Transfer activities. Oversee qualification and lifecycle management of R&D laboratory equipment, including review and approval of URS, IQ/OQ/PQ, and calibration/maintenance documentation. Collaborate cross-functionally with Analytical Development, Formulation, Regulatory Affairs, and Technical Operation to ensure robust quality oversight of CMO activities. Manage and oversee the stability program for registration purposes, including protocol development, data review, trending, and reporting. Review CMC submission for approval of new marketing authorization and for post-approval changes of approved products. Lead or provide QA guidance on investigations of OOS and OOT results, ensuring timely, thorough, and compliant root cause analysis and CAPA implementation. Drive continuous improvement initiatives in QA systems, processes, and documentation related to R&D quality support. Maintain inspection readiness and contribute to successful regulatory agency inspections and partner audits. Build, coach, and manage a high-performing QA team to support R&D functions. Stay current with global regulatory expectations, industry best practices, and emerging trends in R&D QA. Qualifications And Education Requirements Bachelor’s or master’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field). Minimum 10 years of experience in pharmaceutical/biotech Quality Assurance, with at least 5 years in a leadership role. Deep understanding of cGMP, ICH guidelines, method validation/transfer, and regulatory submission requirements. Experience in supporting method transfer and validation at CMOs and in overseeing registration stability programs. By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 1 week ago
0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
A career in our Advisory Acceleration Centre is the natural extension of PwC’s leading class global delivery capabilities. We provide premium, cost effective, high quality services that support process quality and delivery capability in support for client engagements. JOB OVERVIEW PwC US ADVISORY – MANAGEMENT CONSULTING Our Management Consulting team works with our global clients to design and implement growth, operational and customer focused strategies for sustainable competitive advantage. Our thought leadership and unparalleled experience help clients turn formidable challenges into market advantage across the value chain and around the globe. Additionally, our extensive expertise in various industries allow us to serve clients with consulting services with a focus on the most profitable elements of the value chain to create scalable businesses that will deliver increased sustainable profits. Our Management Consultants work with the client and project teams to support global engagements from India through activities that are driven towards delivering results- conduct analyses and develop insights, prepare excel models, analyze large sets of data, capture as-is processes, prepare work plans, design to-be processes, support project lead, work directly with client teams and facilitate meetings to enable decision making, organize and prepare recommendations on client issues, and participate actively in new business development, thought leadership and firm building activities. COMPETENCY OVERVIEW: HEALTH TRANSFORMATION (HT) The HT team works with clients across healthcare, supporting engagements in driving client’s strategic vision and objectives, assessing market expansion and growth strategies, researching key market trends and its impact on key stakeholders, driving operational and process improvements, evaluating sustainable cost transformation alternatives and enabling technology driven business success. Our consultants work to provide a range of client solutions across the following areas: Pharma & Life Sciences: We help clients in R&D and commercial domains. Our services span across launch & commercial planning, portfolio optimization, performance management, R&D innovation, product development, product lifecycle management, risk / compliance, internal audit, risk assessment, management and control. Payer: We work with clients to bring operational and performance improvement in their core Payer functions with the help of our deep understanding of core functional areas. We help in designing the future operating model, payment model, growth strategy, and functional/technical transformation, Business transformation. Our services span across operational performance improvement including benchmarking, process mapping and design, operating model design, project management, data and analytics strategy, technology effectiveness assessments and market strategy Provider: We work with health systems to develop, design, and implement organizational transformation to improve performance and generate lasting growth. Our services span across operational performance improvement including labor and productivity assessments, portfolio rationalization, benchmarking, process mapping and design, operating model design, project management, technology effectiveness assessments and market strategy Capability - R&D Operations and Strategic Planning Knowledge - Essential Strong understanding of the US Pharmaceutical and Life Sciences landscape, R&D operations, and clinical trial data management system R&D Operations business process and model covering portfolio, resource and financial management R&D governance & executive reporting framework Experience in conducting qualitative and/ or quantitative benchmarking Knowledge - Preferred – Experience in decision analytics Clinical systems validation and integration Standard data Tabulation Model on clinical data analysis ETL data process, data pipeline development, migration and data implementation across third party tools Project and portfolio management tools such as Anaplan, Eplan, CTMS systems Planisware, Smartsheet, Microsoft project plan Skill Set - Essential Analytical mindset with strong quantitative and problem solving skills Ability to conduct primary and secondary research Proficient in Python, SQL and any other statistical tools Expert level proficiency in MS office and G-Suite Basic proficiency in cloud technologies Skill Set - Preferred Ability to research, synthesize and integrate disparate pieces of data, analysis, and information Proficient in at least one of the visualization tools such as Tableau, PowerBI, and React Proficient in one or more from following skills: R SQL Python SaaS VBA Power Quer Capability - Clinical Trial Strategy Knowledge - Essential Strong understanding of the clinical trials landscape In-depth knowledge / experience working in clinical trial design or strategy- drugs/ medical devices (Protocol design, viability of trial sites, patient populations, decentralized trials, patient burden, etc.) Ability to provide strategic recommendations to improve trial efficiency, quality, and patient safety Ability to understand different therapeutic areas (e.g., oncology, endocrinology, cardiovascular, rare diseases) Experience working with databases such as ClinicalTrials.gov, TrialTrove, EudraCT, etc. Knowledge - Preferred Strong understanding of Good Clinical Practice (GCP) guidelines, industry standards, and regulatory requirements, particularly in United States and EU regions Ability to contribute to the development and improvement of study processes, SOPs, quality control measures, regulatory submission dossiers Skill Set - Essential Analytical mindset with strong quantitative and problem solving skills Ability to conduct primary and secondary research Ability to identify use cases of emerging technologies and their applications in clinical trials, such as artificial intelligence and machine learning Expert proficiency in MS office and G-Suite and basic proficiency in Python and SQL Skill Set - Preferred Ability to research, synthesize and integrate disparate pieces of data, analysis, and information Proficient in at least one of the visualization tools such as Tableau, PowerBI, and React Additional Skill Sets Applicable Across Capability Areas: Communicating effectively in written and verbal formats to various situations and audiences Compelling storytelling through creative presentation and powerful visualization (including Tableau, PowerBI) Hypothesis based problem solving with abstract/limited data Proficiency in Microsoft Office Suite of tools Demonstrates flexibility in adapting to changing client/business needs Flexibility to work across multiple sectors Demonstrates ability to work in a global delivery model Educational Background: Degree Preferred: MBA / MHA from a premium B-School / MPharm or (MBBS / BDS + MBA) / MS in Biotechnology or Pharmaceutical Sciences Additional Information: Level: Experienced Associate Function: Pharma and Life Sciences Experience: 12 to 36 months of relevant work experience Time Type: Full time Work Timings: Work hours may vary for specific projects Travel Requirements: Travel to client locations may be required as per project requirements Office Location: Bangalore (Preferred) Show more Show less
Posted 1 week ago
5.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Brief Team/department Description We have an exciting opportunity—the person we select for this role will play a key part in Azurity’s digital transformation! We are in the building phase of growing our digital to meet the future growth of the organization. This is a hands-on role and the expectation is that the incumbents will on occasion need to roll up the sleeves and take matters in their own hands. Principle Responsibilities Serves as an escalation point for application support and troubleshooting, provides guidance and direction in resolution of escalated issues and/or complex production, application or system problems Manage the tools like Active Directory, IAM, Intune, Defender etc. Manage Azure Cloud Infrastructure. Own Root Cause Analysis and Problem Management for corporate Identity Management environment (Entra) Perform daily system monitoring, verifying the integrity and availability of all Systems, hardware, server resources, systems and key processes, reviewing system and application logs, and verifying completion of scheduled jobs Create and maintain system documentation for domain technologies, including installation, configuration, and appropriate troubleshooting steps Improve existing processes through solutions to recurring problems and enhancements to existing solutions or documentation Manage customer satisfaction through effectively communicating and managing customer expectations Strong understanding of M365 components and licensing models. Automate the mundane tasks using PowerShell, Shell Scripts, Python etc. Qualifications And Education Requirements Bachelor’s Degree (accredited school) or equivalent with emphasis in computer/information science or information technology 5 years of experience in IT infrastructure Able to work in project teams, under pressure, facilitate discussion, decision-making and conflict resolution. Excellent communicator, able to engage and effectively respond to diverse stakeholders Willingness to participate in on call Fluent in English Preferred Skills And Experience Very strong working knowledge of Microsoft tech stack - Microsoft Active Directory (AD), Azure AD, IAM, DNS, DHCP, Intune, Defender, Entra ID etc. Work experience with Microsoft Azure Cloud. Comprehensive experience with enterprise multi-forest infrastructure models Building servers and virtual machines in compliance with established practice. Extensive knowledge of client / server operating systems (Linux, UNIX, and Windows), backend infrastructure services and networking, Group Policy Objects (GPOs), certificates, and their impact on Active Directory Experience on Microsoft Hyper-V and backup systems Knowledge of Identity and Access Management (IAM), authentication and authorization in particular By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance. Show more Show less
Posted 1 week ago
30.0 years
0 Lacs
Navi Mumbai, Maharashtra, India
On-site
We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our Clinical Safety department in India. This position will be focused on the handling and processing of adverse events from all sources, including clinical trials and post marketing surveillance. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you! Responsibilities Determine plan of action for incoming calls; Collect, process, and track incoming adverse and serious adverse events; Write safety narratives; Report on various safety data; and Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes. Qualifications Bachelor's degree in Healthcare related field; Nursing, Pharmacy, Pharmacology, etc Clinical experience or Clinical Research, case processing and Post marketing Pharmacovigilance experience is preferred; Proficient English is required Proficient knowledge of Microsoft® Office; Broad knowledge of medical terminology; and Strong organizational and communication skills. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. Show more Show less
Posted 1 week ago
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