1188 Clinical Research Jobs - Page 20

We re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings Perceptive is seeking a skilled Network Operations Center (NOC) & End User Compute Service Desk Engineer to join our dynamic team. The successful candidate will be responsible for providing technical support and ensuring the smooth operation of our network, end-user computing environments, and Microsoft Azure server environments. This role requires a proactive individual with strong problem-solving skills and the ability to work effectively in a fast-paced environment. The position is shift-based, supporting a 24x7 rotational to ensure continuous coverage and support. Additionally, the role involves major incident management to swiftly address and resolve critical issues. Key Responsibilities Monitor and manage network environments Ensure optimal performance and update of critical network infrastructure Provide technical support to end users Resolve issues relating to hardware, software and mobile telephony across our end userbase Perform routine maintenance and updates Maintain and update network and compute environments Collaborate with other functions and teams within IT and the wider business unit Troubleshoot and resolve complex technical issues Maintain knowledge documentation Document network configurations, procedures and known issues Assist in the implementation of new technologies Implement and upgrade new services and platforms, adhering to appropriate change controls Ensure compliance with company policies Adhere to company and industry standards for security, data protection and all Standard Operating Procedures Respond to and manage incidents and service requests Respond and resolve incidents and requests within SLA/OLA Manage and support Microsoft Azure environments Monitor performance, troubleshoot issues and ensure security and compliance Implement and maintain Azure based solutions Manage virtual machines, storage accounts and networking components Major Incident Management Working with Service Management, coordinate and document major incidents through to resolution Problem Management Working with Service Management, coordinate and document post incident reviews and root cause information, as well as preventative information Change Management Working with Service Management ensure all changes to our environments are documented and approved through appropriate processes Other Carryout any other reasonable duties as requested. Functional Competencies (Technical knowledge/Skills) Strong knowledge of network protocols, hardware, and software. Experience with network monitoring tools and troubleshooting techniques. Familiarity with end-user computing environments, including desktops, laptops, and mobile devices. Experience with Microsoft Azure, including managing virtual machines, storage, and networking components. Excellent communication skills and the ability to work effectively with both technical and non-technical stakeholders. Ability to manage multiple tasks and priorities in a fast-paced environment. Core knowledge of ITIL processes, including but not limited to Major Incident, Problem and Change Management Experience, Education, and Certifications Proven experience in a similar role within a Network Operations Center or IT Service Desk environment. Bachelors Degree in a technical discipline or equivalent project-related experience. Willingness to work in a shift-based role supporting a 24x7 rotational. Microsoft Azure Certifications and ITIL V4 Certifications are preferential but not essential. English: Fluent.

Principal Biostatistician Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by SDC. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning. Primary Responsibilities Serve as an internal consultant for biostatistics analysis tools and methods Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support Actively support business development in capabilities presentations to prospective and current clients Effectively manage assigned clinical study budgets for biostatistics analysis support Develop, coach and mentor junior biostatistics department personnel Act as the lead statistician on clinical research projects and help with SAS programming Provide statistical expertise for study design of clinical trial protocols Write statistical methods section of the study protocol, as needed Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP) Program summary tables, data listings and graphical representations of clinical trials data Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data Prepare/review key sections of clinical study reports and various regulatory documents Perform statistical QC of all department outputs including analyses and clinical study reports Provide statistical support to answer questions from external clients (such as FDA, Investigators) Contribute to the development, maintenance, and training of standard operating procedures (SOPs) Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed Manage biostatistics timelines, budgets, and client expectations Adhere to all aspects of the Statistics & Data Corporation s quality system Comply with Statistics & Data Corporation s data integrity & business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Required Skills Effective leadership, budget forecast and implementation skills Excellent analytical skills, with the ability to process scientific and medical data Able to work independently and in teams Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills Excellent knowledge of statistical programming Expertise in manipulating and analyzing SAS data Able to identify data issues, present problems, and implement solutions. Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients Excellent organizational and time management skills, with the ability to multi-task Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) Strong interpersonal communication and presentation skills Able to effectively collaborate across cross-functional teams Focus on quality at all times and in all situations Education or Equivalent Experience A Master s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience. Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid

As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Travel (approximately 10%) domestic and/or international. Roles and Responsibilities With support, manages projects in a timely manner in adherence with SOPs and appropriate regulations and liaises with other department managers as necessary to achieve this. Act as the key client contact for designated projects and develop successful working relationships with others. Develops succession plans when needed, and in the event of a change to the project team, ensures a thorough and effective handover which is appropriately documents. With support, leads the development and maintenance of project management documents, including but not limited to, project timelines, project management plans, communication plans and risk analysis plans. With support, leads the review/approval of project related materials, including but not limited to, protocol/guidelines, informed consent forms, case report forms, site training materials, reports, newsletters. With support, monitors the quality specification within the project. Liaises appropriately with internal functional leads and clients on project related matters. With support, leads the assessment of project specific site training and site management with Research Services and Clinical Operations departments, in an effort to ensure project efficiency and consistency. Supports the management of project financials using the appropriate tools, including but not limited to, understanding full scope of work and assumptions for work to be conducted, change in scope, client and vendor invoicing/reimbursement, grant payments. Collaborate with Finance to ensure appropriate revenue recognition. Keeps senior management informed of project status in relation to quality, timelines and staff issues. Maintains confidentiality of management information as appropriate. With support, liaise with PRM group to ensure appropriate staffing throughout project lifecycle. Monitor project staff allocation in appropriate resource management system(s). Business Development Supports the formation of strategic alliances with internal and external customers. Supports the development of proposal defense presentations.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs. Essential Functions: Indepentendly performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Client s disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency. Educational Requirements: Minimum of bachelor s degree in related field (scientific field preferred). Experience Requirements: Minimum of 2+ years of direct experience in disclosures and/or data transparency. CRO or Outsourcing experience preferred. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Career Area: Engineering : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Role Definition: Manage product regulatory compliance risks (non-emission) and ensure compliance for all Caterpillar and allied products / business and enable market access in India region*. (*) India regionIndia, Sri Lanka, Nepal, Bhutan and Bangladesh Responsibilities Actively engage / proactively work with pertinent Standards Development Organizations ( SDO) such as Bureau of Indian Standards(BIS), Indian Road Congress(IRC), Regulators, and Trade Associations (TA) to drive advocacy / draft requirements for Construction Earthmoving , Material Handling and Mining (CEMM) Industry. Identify / Stay abreast on current and upcoming India region product regulatory requirements. Assess implications of upcoming regulations on Caterpillar products, solutions, and services. Collaborate with Government affairs team, TA s and Ministry to mitigate potential compliance challenges Work with all related teams to ensure that all Caterpillar products, solutions, and services are compliant after effective date. Be part of NPI teams to proactively guide / ensure all products placed in India region market meets regulatory requirements Develop guidance documents to guide all internal teams on regulatory requirements. Periodically update all stakeholders on regulatory developments. Identify continuous improvement opportunities for processes and tools used to manage product regulatory compliance risks. Degree Requirement B.E/ B.Tech from an accredited institution is mandatory with 12+ years of relevant experience in Engineering, Marketing or other areas in the organization is preferred. Skill & Competency Descriptors Technical knowledge Deep Product and process knowledge: Level Extensive experience Working knowledge of CAT Products, Product application / usage, services & solutions provided in India region Good working experience of CAT processes (NPI, Trade, Certification) Strong communication skills - Verbal and written Experience of working with several product groups a plus Collaborating skillsAbility to work with all stakeholders in a constructive and collaborative manner. Level Working Knowledge: Demonstrates experience participating in productive collaborative processes. Initiates collaborative meetings with all pertinent stakeholders. Communicates plan / actions to manage compliance risks Supports to promote collaboration across functions, businesses, and levels. Helps solve business problems and meet business goals through collaborative processes. Risk ManagementKnowledge of processes, tools and techniques for assessing and controlling an organization's exposure to risks of various kinds; Ability to apply knowledge of risk management appropriately to diverse situations. Level Working Knowledge Proactively identifies compliance risks (non-emissions) for all Caterpillar businesses in India Leverages risk assessment models and techniques to assess compliance risks. Leverages Produces and interprets common risk assessment and management reports. Implements or manages risk management for own area. Documents the key steps of risk management and associated procedures. Product Development Knowledge of product development process and leverages knowledge to ensure compliance aspects are embedded as part of product development. Level Working Knowledge Reviews and assesses proposed solutions to mitigate compliance risks. Creates, disseminates, and maintains best practice documentation. Monitors the use and feasibility of best practices within a product development department on compliance matters Highlight any issues related to major resources and logistics for applying best practices. Willing to travel Approx. 30% Relocation is available for this position. Posting Dates: May 29, 2025 - June 5, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to applyJoin our Talent Community .

Role Description Overview: Coder is accountable to manage day to day activities of coding the Patients chart & Diagnosis report. Responsibility Areas: Coding or auditing charts, based on requirements Updating/Clearing the production/pending reports To work closely with the team leader. To review emails for any updates Identify issues and escalate the same to the immediate supervisor Strict adherence to the company policies and procedures. Sound knowledge in Medical Coding concept. Should have 6 months to 3 Yrs of Coding Experience. Understand the client requirements and specifications of the project. Meet the productivity targets of clients within the stipulated time (Daily & Monthly) Applying the instructions/updates received from the client during production. Coding or auditing charts, based on requirements. Prepare and Maintain reports

Role Description Overview: Coder is accountable to manage day to day activities of coding the Patients chart & Diagnosis report. Responsibility Areas: Coding or auditing charts, based on requirements Updating/Clearing the production/pending reports To work closely with the team leader. To review emails for any updates Identify issues and escalate the same to the immediate supervisor Strict adherence to the company policies and procedures. Sound knowledge in Medical Coding concept. Should have 6 months to 3 Yrs of Coding Experience. Understand the client requirements and specifications of the project. Meet the productivity targets of clients within the stipulated time (Daily & Monthly) Applying the instructions/updates received from the client during production. Coding or auditing charts, based on requirements. Prepare and Maintain reports

: In Scope of Position based Promotions (INTERNAL only) Job Title Auditor Associate Location Bangalore, India Role Description The Audit Analyst/Auditor will be initially working with the various teams supporting the coverage of Indian and other APAC legal entities and processes. After the initial training and development phase, the Audit Analyst/Auditor will eventually join one of the global audit teams on a permanent basis. Timing of the permanent assignment will vary depending on personal development, experience and opportunities available. During the initial assignment, the Audit Analyst/Auditor will be exposed various audit processes covering key divisional and infrastructure units. In addition, the Audit Analyst/Auditor will also support ad hoc RBI requests where appropriate. In addition to conducting audit work across these functions, the team also works closely with other audit teams (e.g. Technology) to provide integrated coverage and assurance. The Audit Analyst/Auditor works on supervised audit activities and undertakes audit work of a specific business/function area in accordance with the audit methodology and evaluates the adequacy and effectiveness of internal controls. The Audit Analyst/Auditor works in a cooperative manner with subject matter experts and other teams from across the function to provide front-to-back audit coverage. The Audit Analyst/Auditor will use a range of approaches to collect relevant and readily available information to assess risk, resolve issues or carry out tasks. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy, Best in class leave policy. Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Auditor: Auditors work independently on audits and/or on tasks delegated to them within the scope for audits for a specific business/functional area/region and may sometimes work on multiple audits at the same time. Auditors evaluate the adequacy and effectiveness of internal controls relating to the risks within those business areas, working under moderate supervision, e.g. in complex situations. Auditors proactively develop and maintain professional consultative working relationships within their own function and with stakeholders inside the bank and respective support areas. They will use a range of approaches to collect relevant information to assess key risks, resolve issues or carry out tasks. Auditors work in a co-operative manner with subject matter experts and other teams from across the function and outside the function to provide front-to-back audit coverage. Auditors may occasionally participate in ad-hoc projects. Audit Analyst: The Audit Analyst supports on audits of a specific business/functional area/region, with specific guidance. They predominantly support the audit team on analytical aspects of audit work throughout the entire audit lifecycle. The Audit Analyst will focus on the fieldwork phase of an audit and building a working knowledge of the audit methodology. Assists on audit assignments and undertakes work in accordance with the Audit methodology within agreed budgets and timelines, including documenting Activity Flows, identification of key risks, testing of key controls to evaluate the adequacy and effectiveness and documenting work in accordance with divisional standards. Proactively keeps abreast of pertinent industry, regulatory and business practices. Proactively develops and maintains professional consultative working relationships, primarily within the audit team. Takes ownership for own development and career management, seeking opportunities for continuous development of knowledge and personal capability and improved performance contribution and acts as a role model within their own team. Your skills and experience The candidate must have: Bachelor Degree (or equivalent) from an accredited college or university (or equivalent); including some knowledge of auditing standards and concepts. Awareness of general banking environment and/or awareness of the risks and regulatory requirements. Fluent in English, communicating with clarity, both verbally and in writing, in a logical order and structured approach. Dedication on self-development and building technical knowledge. Advanced knowledge of Microsoft Excel, Word and Power Point. Critical thinker with understanding of emerging technologies (Cloud, AI, Python etc.) Good analytical, problem solving, relationship management and presentation skills. Ability to work in virtual, global teams in a matrix organisation. Self-starter with the ability to multi-task assignments, prioritize workload and be resilient under pressure when faced with tight deadlines and in a fast-paced business environment The ability to challenge and be challenged whilst maintaining the highest levels of professionalism. Unquestionable personal integrity and ethics. How we'll support you Training and development to help you excel in your career. Coaching and support from experts in your team. A culture of continuous learning to aid progression. A range of flexible benefits that you can tailor to suit your needs.

The purpose of the Research Scientist, Japan Value, Evidence and Outcomes (Japan VEO) is to deliver valuable evidence that addresses health outcomes issues, maximizes product value in Lilly portfolio, and contributes to improvement of people s health by demonstrating scientific leadership in evidence strategy development, planning, HEOR/RWE study development and execution. The research scientist will provide strategic insight/leadership into the health outcomes (HO) evidence needs (eg, health economics, patient reported outcomes, real world evidence) for Lilly s portfolio. The scientist will integrate their knowledge of health outcomes disciplines, therapeutic area knowledge of disease states in the Lilly portfolio, understanding of drug development and commercialization, and local market knowledge in the role to deliver valuable evidence, partnering with global VEO/VEO International as we'll as local functions. Research project ownership and execution is required. The scientist may have duties ranging from developing and articulating product value propositions, patient reported outcomes strategies, real world evidence generation, and differentiation strategies using HO research depending on the individual assignment. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Strategy Develops and oversees local HEOR/RWE strategy for compounds in the Lilly portfolio in Japan in the relevant therapeutic area(s) that is aligned with local product strategy and global/regional HEOR/RWE strategy. Drives sustained integration of HEOR/RWE from early clinical development through commercialization depending on focus of the assigned project or therapeutic area. Formulates and drives Patient Focused Outcome, Real World Evidence, and/or economic value strategies for priority products. Provides strategic direction to address complex health outcomes challenges. Study Development and Execution Leads local HEOR/RWE evidence planning and execution for individual compounds/products across the development and commercialization lifecycle to support drug development, optimize pricing and access, and maximize post-launch product value in collaboration with local cross functional team and/or global VEO/VEO International. Develops and designs HEOR/RWE studies that can address important gaps for the products, is scientifically robust and feasible, and meet relevant quality standards. Applies technical expertise appropriate for the role (eg, scope or depth in statistical analysis, economic modeling, clinical trials, PFO development, observational/ epidemiologic research methodologies) within a therapeutic area. Ensure sustainable delivery of planned evidence in a timely manner. Organizational Leadership and Influence Demonstrate scientific leadership in evidence strategy, planning, study development and execution. Links technical expertise with business acumen and establishes and maintains strategic relationships with key internal and external decision makers. Effectively integrates with and influences key business partners and external stakeholders to achieve goals and outcomes Promote strategic integration into global for both projects and functional activities. Can apply unprecedented innovative approaches with taking a risk to deliver best results. Information Dissemination Effectively communicates HO information to internal business partners, the scientific community, and customers. Drives research dissemination strategies and leads research communication efforts including abstracts, posters, podium presentations, promotional materials, and manuscripts. Plan for, align, and drive application of results/ deliverables to increase the impact of HO work. Actively participates in shared learning opportunities to effectively share knowledge and experience (both positive and negative) of management tools and other learnings with colleagues and peers, locally and internationally. Prioritized capability/experience : Capability/experience to execute observational research (eg, database research), from protocol development to statistical analysis and publication. Basic statistical analysis skill using available RWD database Strongly preferred skill: statistical analysis programming skill (eg R) Target Literature Review Expected types of tasks to be covered/supported by LCCI scientists. Statistical analysis of internally available data using IHD or R program as a part of observational study or to respond to request from internal (to support internal decision making). Support for protocol development and publication (manuscript, disclosure at academic conf). Target literature review to support evidence planning and research planning. Implementation or support of entire observational study execution Environmental Awareness Maintains awareness of significant developments in disease states in the Lilly portfolio and HO field including current HO methodologies and applications, availability in various real world data, relevant regulations, and other issues as appropriate for the position. Anticipates and evaluates future market needs and trends for HO information within pertinent therapeutic area and geography of interest. Monitors and influences internal and external environmental factors that shape and impact generation and use of HEOR/Rwe'research. Maintains a presence and relationship with the research community related to the relevant areas. Project Management Partner with Project Managers in Japan VEO to ensures projects meet timelines, budget, and scope by coordinating research efforts with cross-functional team and external collaborators as appropriate. Minimum Qualification Requirements: An advanced degree, including Ph.D., M.D., or PharmD/masters degree with relevant experience in an appropriate discipline (eg, economics, epidemiology, health administration, health services, medicine, pharmacoeconomics, psychology, statistics, or other relevant sciences) will generally be required, although significant previous training and experience in designing and conducting research and disseminating the results in the areas of health economics, health outcomes, disease management, and/or population health may substitute for the formal degree requirement. Strong comprehension and communication skills including the ability to translate and disseminate complex scientific information in a clear and concise manner Strong business English and Japanese skill Demonstrated ability to influence and collaborate within and across teams The ability to think and act globally with a customer focus and a solution orientation. Other Information/Additional Preferences: Knowledge and experience of health care systems in major countries as appropriate for the position requirements. Understanding of and experience with clinical settings and clinical research. Technical and analytic capabilities in the areas of economic modeling, economic evaluation, burden of disease, epidemiology, statistics, health care policy etc.

Develop interactive dashboards and reports in Amazon QuickSight using pre-configured data sets and schema definitions, ensuring outputs are intuitive and actionable Create and manage calculated fields and derived metrics from base datasets to support key business questions and performance monitoring Extend QuickSight capabilities beyond basic usage leveraging advanced features such as parameters, actions, filters, and embedded visualizations based on documentation and community insights Collaborate with cross-functional teams including product managers, UX designers, data engineers, software engineers, and clinical operations to ensure dashboards align with user needs and operational goals Validate and QA dashboards, ensuring that visualizations meet design standards, stakeholder expectations, and data quality benchmarks Other duties as assigned Overview BI Analyst India: Bengaluru - hybrid Emmes Group: Building a better future for us all Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience We believe the work we'do will have a direct impact on patients lives and act accordingly We strive to build a collaborative culture at the intersection of being a performance and people driven company we're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company If you share our motivations and passion in research, come join us! Primary Purpose The Business Intelligence Analyst role requires design and development of interactive dashboards and reports using Amazon QuickSight Responsibilities include creating calculated fields, building insightful visualizations, and ensuring data accuracy through validation and debugging This role involves close collaboration with engineers, data scientists, and designers to deliver high-quality, user-centric dashboards that align with business requirements and design standards Responsibilities Develop interactive dashboards and reports in Amazon QuickSight using pre-configured data sets and schema definitions, ensuring outputs are intuitive and actionable Create and manage calculated fields and derived metrics from base datasets to support key business questions and performance monitoring Extend QuickSight capabilities beyond basic usage leveraging advanced features such as parameters, actions, filters, and embedded visualizations based on documentation and community insights Collaborate with cross-functional teams including product managers, UX designers, data engineers, software engineers, and clinical operations to ensure dashboards align with user needs and operational goals Validate and QA dashboards, ensuring that visualizations meet design standards, stakeholder expectations, and data quality benchmarks Other duties as assigned Qualifications bachelors degree in a quantitative field such as Mathematics, Business, Economics, Engineering, or a related discipline 4 years of experience working as part of team in a business intelligence analyst or equivalent role Hands-on experience with leading BI tools such as Tableau, Power BI, or other visualization platforms, with demonstrated ability to build clear, insightful dashboards Ability to quickly learn new BI tools this role will require onboarding to Amazon QuickSight Prior experience in learning new platforms independently using documentation and community resources is a strong plus Strong analytical skills with the ability to interpret and work with complex data sets, drawing meaningful insights that support business and clinical goals Exceptional attention to detail to ensure data accuracy, consistency, and integrity across reports and dashboards Strong visualization quality control mindset, ensuring all visual elements match design mocks, specifications, and stakeholder expectations Familiarity with clinical trial data or healthcare-related datasets (at least at a high level), including concepts like patient visits, protocol events, and outcomes tracking

Job Information Job Opening ID ZR_1557_JOB Date Opened 19/11/2022 Industry Technology Job Type Work Experience 5-8 years Job Title Visionplus Developer City Mumbai Province Maharashtra Country India Postal Code 400008 Number of Positions 4 LocationMumbai, Pune, Chennai, Hyderabad, Bangalore, Kolkata, Coimbatore Strong Vision Plus experience Expert in atleast 1 of the Modules like CMS, FAS Strong Communication skills Good in working both as independent contributor or team member Should have Technical and Functional design Experience in one of the VisionPLUS modules CMS, FAS, MBS, ASM, CTA, CDM, WSS/SSC Should be able to prepare Technical Specification, Functional Specification and High Level Design documents independently Should have good understanding of Cards Domain, Payment gateway Should have detailed technical understanding of V+ Batch and Online Architecture, VisionPLUS Functional Architecture and Mandatory Parameter configurations Should be able to create VisionPLUS test data for Unit Testing, Integration Testing and SIT. Should support SIT/UAT team on defect resolution and should participate in Defect review meetings Should be able to prepare Integration test Plans independently. Should be able to configure a VisionPlus module independently for Integration testing. check(event) ; career-website-detail-template-2 => apply(record.id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#2B39C2;border-color:#2B39C2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered=""> I'm interested

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Programmer to join our Biometrics team. This position will work in 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. 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 Develop, program, validate and maintain clinical trial databases according to company standards; Maintain and contribute to company library of standard CDASH compliant CRFs ; and Act as primary contact to the data management team for assigned studies, supplying all necessary technical support, and ensuring quality of the programming and adherence to company standards. Qualifications Bachelor’s degree/Advanced degree in Life Sciences or Computer Science or equivalent; Min 3 years of Rave study build experience in a similar position in Pharma/Healthcare sector; Custom function (C# Programming) experience is preferred; Certified Medidata Rave Study Builders preferred; Excellent verbal and written communication skills; and Meticulous attention to detail. 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.

Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Periodic Report Specialist What you will do Let s do this. Let s change the world. This position plays a role in the authoring, compilation and peer review of Amgen s Periodic Aggregate Safety Reports (PASR) e. g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e. g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Compilation and authoring of PASRs Coordinate and schedule all meetings with cross-functional collaborators to ensure effective collaboration and alignment Drive report timelines and advance risks or delays to team leads or management Collaborate with cross-functional collaborators and external business partners to collect PASR contributions and compile into PASR template. Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows. Maintain and archive accurate records and documentation throughout the report process. Review and approve published report versions (i. e. blinded, unblinded, EU FDA, Rest of World). Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs) Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs). Responsible for the generation, including authoring of safety sections of all PASRs, including publishing approvals, metrics generation and archiving of source documents. Responsible for the scheduling and lead of all PASR meetings throughout PASR production Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Support audit and inspection deliverables, including but not limited to information requests and response QC. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Understands and interprets data/information and its practical application Knowledge of scientific/technical writing and editing Excellent English written/oral communication, and strong time and project management skills Strategic approach, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations. Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting Ability to effectively manage competing priorities and timelines Strong leadership skills, independence, networking and influencing skills Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e. g. Veeva Vault Experience in use of AI and prompts would be useful Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic / aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of relevant work experience Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Periodic Report QC Reviewer What you will do Let s do this. Let s change the world. The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e. g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e. g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e. g. , PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e. g. , Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Periodic Report Manager What you will do Let s do this. Let s change the world. This position plays a role in the authoring, compilation and peer review of Amgen s Periodic Aggregate Safety Reports (PASR) e. g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e. g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. Incompliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. In addition, this role has oversite of a team of Periodic Report Specialists. Key Responsibilities: Management responsibility for a team of Periodic Report Specialists Supervision of a team of Periodic Report Specialists in Amgen India with Periodic Report responsibilities Act as primary point of contact for the reports, present anticipated challenges and propose remediation and advance unresolved issues impacting deliverables. Act as a writing coach, provide regular quality feedback, and share standard methodologies with PRS for promoting the use of clear and concise writing and adherence to style guides and templates as applicable. Ensure compliance of operations with governing regulatory requirements. Compilation and authoring of PASRs Coordinate and schedule all meetings with cross-functional collaborators to ensure effective collaboration and alignment Drive report timelines and advance risks or delays to team leads or management Collaborate with cross-functional collaborators and external business partners to collect PASR contributions and compile into PASR template. Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows. Maintain and archive accurate records and documentation throughout the report process Review and approve published report versions (i. e. blinded, unblinded, EU FDA, Rest of World). Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs) Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs). Management of a team of Periodic Report Specialists Responsible for the generation, including authoring of safety sections of all PASRs, including publishing approvals, metrics generation and archiving of source documents. Responsible for the scheduling and lead of all PASR meetings throughout PASR production Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Support audit and inspection deliverables, including but not limited to information requests and response QC. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 4 to 6 years of pharmaceutical, biotech or regulatory authority experince in a research and development setting experience OR Bachelor s degree and 6 to 8 years ofpharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 10 to 12 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Understands and interprets data/information and its practical application Knowledge of scientific/technical writing and editing Excellent English written/oral communication, and strong time and project management skills Strategic approach, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations. Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting Ability to effectively manage competing priorities and timelines Strong leadership skills, independence, networking and influencing skills Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e. g. Veeva Vault Experience in use of AI and prompts would be useful Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic / aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 5 - 7 years of relevant work experience including 5 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 4 years of Experience in managing personnel directly or providing leadership by guiding teams, overseeing projects or programs, or directing resource allocation. Overall 5 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying medical or technical information into clear, structured documents and engaging content. Good Knowledge of Medical terminology. Required Candidate profile Preparation of protocol for Clinical trials Preparation writing CSR (Clinical Study Report) BDS and MBBS With medical writing for clinical trials Knowledge are Applicable

Should have knowledge in Clinical Data Managemen Should have good knowledge in edit checks crf design SAE Reconcilation crf annotation Good knowledge in Startup conduct phase and close out phase Required Candidate profile Strong understanding of clinical data management and E2b Guidelines Excellent clinical assessment and Communication Skills

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Develop and maintain effective regulatory writing processes and practices. Supports the safety and compliance function (SCR) in performing the required activities that ensure compliance with domestic and international regulatory agency requirements and standards, in line with customer requests. Work with suppliers and stake holders to get required evidence as per the compliance requirement. Support requests for testing from country and/or regulatory agencies. Support teams in preparing product technical reports and Safety risk assessment reports. Support Material compliance requirement from markets: EU REACH, ROHS, Prop 65, SCIP & other regulatory requirements.

We are seeking a dedicated and motivated Senior Resident in Physiology to join our dynamic team. The ideal candidate will have a strong foundation in physiology, with a passion for clinical research and patient care. This role offers an opportunity to enhance your expertise while contributing to the advancement of medical knowledge. Responsibilities Conducting clinical assessments and physiological evaluations of patients. Assisting in the development and implementation of research studies in physiology. Collaborating with multidisciplinary teams to optimize patient care and outcomes. Participating in educational programs for medical students and junior residents. Maintaining accurate and detailed patient records and documentation. Skills and Qualifications MD in Physiology or equivalent from a recognized institution. Strong understanding of human physiology and related clinical practices. Excellent communication and interpersonal skills. Ability to work effectively in a team and independently. Proficiency in data analysis and research methodologies. Basic knowledge of medical software and electronic health records.

We are seeking a dedicated and knowledgeable Senior Resident in Pharmacology to join our healthcare team. The ideal candidate will play a crucial role in advancing pharmacological research and improving patient care through effective drug management and clinical trials. This position is suitable for candidates with 0-1 years of experience in the field. Responsibilities Assist in the development and implementation of pharmacological research protocols. Conduct clinical trials and monitor patient responses to pharmacological treatments. Collaborate with a multidisciplinary team to analyze data and present findings. Participate in patient consultations to provide pharmaceutical care and education. Maintain accurate records of patient interactions, trial results, and research activities. Stay updated with the latest advancements in pharmacology and related fields. Skills and Qualifications MBBS or MD degree with specialization in Pharmacology. Strong understanding of pharmacological principles and drug interactions. Experience with clinical trial protocols and data collection methodologies. Excellent communication skills to convey complex information to patients and team members. Ability to work collaboratively in a multidisciplinary team environment. Proficient in using statistical software for data analysis. Detail-oriented with strong organizational and documentation skills.

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

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