177 Clinical Development Jobs - Page 2

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.

The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills.

YOUR TASKS AND RESPONSIBILITIES: Lead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory meeting. Collaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis. Review of patient eligibility and approval of patients through Interactive Response Technology (IRT) system Work with data management team to review data management plan, coding plan, SAE reconciliation, CRF completion guidelines, edit check specifications. Also, to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs). Coordinate with biostatistician to engage early with the study team to decide sample size, statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents Prepare risk assessment plan based on the protocol of clinical study to identify and address the safety and operation related risk specific to study protocol. Training the study team on protocol and applied aspect of the protocol to clarify the relevance and criticality of each activity considering the study endpoints. Interact with investigator to resolve the queries related with protocol from the sites and Ethics Committee. Medical monitoring activity which includes eligibility assessment based on inclusion, exclusion criteria and detailed medical history, review of study endpoint data review and safety investigations. Review of Adverse Events and Severe Adverse Events forms and provide review comments in timely manner. Planning publications activities for clinical journal manuscripts, abstracts submission for conferences, and subsequent review of posters/ oral presentations. WHO YOU ARE: MD (Pharmacology) or other relevant medical qualification 2-6 years of relevant experience in the field of Medical Monitoring Experience in working in clinical science domain working in different capacities as medical monitor for clinical trial/ medical expert for clinical development plan for products across therapies is desirable. Job location: Sun House, Goregaon East, Mumbai

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Financial Accountant II (Finance transformation)- Chennai ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The Financial Accountant II will work with the wider finance team and finance leadership team in driving the Group s integration and transformation objectives. This role will be key to working within the finance transformation team in identifying and supporting continuous improvement in policies and procedures across the accounting/financial reporting/business partnering group processes. This is an exciting opportunity for an ambitious Finance Accountant to join ICON s experienced and highly motivated finance team at an exciting time for the organization. The individual will play a key role in leading change across the finance organization and delivering key strategic alignment transformation projects. What you will be doing: Supporting finance leadership in the development, implementation and continuous improvement of systems, initiatives and processes. Collaboration within the wider finance organization in the integration of acquisition targets into the group finance structure. Working with interdisciplinary teams to develop and implement group strategy and projects (finance, IT, legal, tax, treasury, HR). Supporting project management of significant change projects across all key finance disciplines. Supporting effective communication across finance in respect of key change projects. Preferably proficient in operating in and leading a strong SOX control environment and providing guidance and direction to the wider group finance team for continuous improvement. Your Profile: Strong communication and project management skills Aptitude or experience in finance process optimisation, automation and systems integrations an advantage. Experience in a range of finance disciplines including e.g. systems change, best practice reporting, P2P, order to cash and treasury processes. An aptitude to identify and lead development, implementation and continuous improvement of projects systems, initiatives and processes. A confident, decisive person with strong interpersonal skills An accomplished professional who is tenacious and determined An experienced high performing ACA, ACCA with minimum 2-4 years PQE Experience in PowerBI and other Business Intelligence tools would be an advantage. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Imaging Support Specialist _ Office Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an Imaging Support Specialist to join our diverse and dynamic team. As an Imaging Support Specialist at ICON, you will play a vital role in providing technical support and assistance for imaging operations within clinical trials. You will ensure that imaging processes run smoothly, facilitating effective communication and coordination among teams and stakeholders. What You Will Be Doing: Providing day-to-day technical support for imaging systems and processes, troubleshooting issues as they arise. Assisting in the setup and maintenance of imaging equipment, ensuring compliance with safety and regulatory standards. Collaborating with clinical teams to ensure proper execution of imaging protocols and adherence to study timelines. Training staff on imaging procedures, software, and best practices to optimize workflow and data quality. Maintaining accurate records of imaging data, system performance, and support requests to facilitate continuous improvement. Your Profile: Bachelor s degree in medical imaging, radiologic technology, or a related field; relevant certifications preferred. 1-3 years of experience in imaging support or a related role, ideally within a clinical research setting. Strong technical skills and familiarity with imaging equipment and software. Excellent problem-solving abilities, with attention to detail and a proactive approach to support. Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Imaging Support Specialist _ Office Based We are currently seeking an Imaging Support Specialist to join our diverse and dynamic team. As an Imaging Support Specialist at ICON, you will play a vital role in providing technical support and assistance for imaging operations within clinical trials. You will ensure that imaging processes run smoothly, facilitating effective communication and coordination among teams and stakeholders. What You Will Be Doing: Providing day-to-day technical support for imaging systems and processes, troubleshooting issues as they arise. Assisting in the setup and maintenance of imaging equipment, ensuring compliance with safety and regulatory standards. Collaborating with clinical teams to ensure proper execution of imaging protocols and adherence to study timelines. Training staff on imaging procedures, software, and best practices to optimize workflow and data quality. Maintaining accurate records of imaging data, system performance, and support requests to facilitate continuous improvement. Your Profile: Bachelor s degree in medical imaging, radiologic technology, or a related field; relevant certifications preferred. 1-3 years of experience in imaging support or a related role, ideally within a clinical research setting. Strong technical skills and familiarity with imaging equipment and software. Excellent problem-solving abilities, with attention to detail and a proactive approach to support. Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Financial Accountant II (Finance transformation)- Chennai The Financial Accountant II will work with the wider finance team and finance leadership team in driving the Group s integration and transformation objectives. This role will be key to working within the finance transformation team in identifying and supporting continuous improvement in policies and procedures across the accounting/financial reporting/business partnering group processes. This is an exciting opportunity for an ambitious Finance Accountant to join ICON s experienced and highly motivated finance team at an exciting time for the organization. The individual will play a key role in leading change across the finance organization and delivering key strategic alignment transformation projects. What you will be doing: Supporting finance leadership in the development, implementation and continuous improvement of systems, initiatives and processes. Collaboration within the wider finance organization in the integration of acquisition targets into the group finance structure. Working with interdisciplinary teams to develop and implement group strategy and projects (finance, IT, legal, tax, treasury, HR). Supporting project management of significant change projects across all key finance disciplines. Supporting effective communication across finance in respect of key change projects. Preferably proficient in operating in and leading a strong SOX control environment and providing guidance and direction to the wider group finance team for continuous improvement. Your Profile: Strong communication and project management skills Aptitude or experience in finance process optimisation, automation and systems integrations an advantage. Experience in a range of finance disciplines including e.g. systems change, best practice reporting, P2P, order to cash and treasury processes. An aptitude to identify and lead development, implementation and continuous improvement of projects systems, initiatives and processes. A confident, decisive person with strong interpersonal skills An accomplished professional who is tenacious and determined An experienced high performing ACA, ACCA with minimum 2-4 years PQE Experience in PowerBI and other Business Intelligence tools would be an advantage. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Typical Accountabilities: Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system. As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalised Initiates and maintains production of study documents, ensuring template and version compliance Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents Manages and coordinates tracking of study materials and equipment Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations Keeps own knowledge of best practices and new relevant developments up to date Liaises with compliance team members to improve regulatory processes within the team Identifies opportunities to improve the methodology and provide practical solutions for clinical development Typical People Management Responsibility (direct / indirect reports): Approximate number of people managed in total (all levels) - None What is the global remit? (how many countries will the role operate in?): Own country Education, Qualifications, Skills and Experience: Essential: Bachelor s degree in relevant discipline; Experience of Study Management within a pharmaceutical or clinical background; Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management Desirable: Advanced degree within the field; Professional certification; Understanding of multiple aspects within Study Management Key Relationship to reach solutions: Internal (to AZ or team): Study management function; Other AstraZeneca employees External (to AZ): External service providers and regulatory bodies 05-Jun-2025 29-Jun-2025

Job description Bangalore, India Job category Clinical Development Department Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position (NoteThis is not a role within Pharmacovigilance) The Key Responsibilities in this position will be to perform a Medical Review of all trial subjects of all assigned clinical trials within the drug development portfolio across therapy areas & to ensure high-quality quality consistent medical data. Medical Review is performed for all trial subjects to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations, and Standard Operating Procedures (SOPs). Senior Medical Reviewer ensures high-quality medical data through medical review of clinical trial data. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialists during trial conduct. Report the status of the medical review to the project as appropriate, following the project communication plan and blinding plan. Consult with Trial Managers and Medical Specialists as appropriate to ensure medical review issues are escalated in a timely manner. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications Minimum as Graduate in Medicine or other relevant (MBBS & MD in pharmacology preferred, MBBS & MD in other clinical/paraclinical areas with relevant experience in clinical patient management/ clinical research). 2-3 years of experience as a Medical Reviewer is preferred. 1-2 years of experience in project management is required. Good knowledge of ICH (International Council for Harmonisation of Technical for Pharmaceuticals for Human Use), and GCP (Good Clinical Practice). Demonstrated computer skills (MS Office, MS Project, PowerPoint). Excellent understanding of medical terminology and clinical trial activities. Strong Analytical skills and result-oriented. Excellent written and spoken English. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we re working toward something bigger than ourselves, and it s a collective effort. Join us! Together, we go further. Together, we re life-changing. Contact To submit your application, please upload your CV online (click on Apply and follow the instructions). 10th May 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we re life changing. Print job Send to e-mail Related jobs

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.

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 Regulatory Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e. g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e. g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgens portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Masters degree and 3 years of relevant regional regulatory experience OR Bachelors degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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 an accommodation. .

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world s most serious diseases. But we re more than one of the world s leading pharmaceutical companies. Typical Accountabilities: Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system. As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalised Initiates and maintains production of study documents, ensuring template and version compliance Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents Manages and coordinates tracking of study materials and equipment Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations Keeps own knowledge of best practices and new relevant developments up to date Liaises with compliance team members to improve regulatory processes within the team Identifies opportunities to improve the methodology and provide practical solutions for clinical development Typical People Management Responsibility (direct / indirect reports): Approximate number of people managed in total (all levels) - None What is the global remit? (how many countries will the role operate in?): Own country Education, Qualifications, Skills and Experience: Essential: Bachelor s degree in relevant discipline; Experience of Study Management within a pharmaceutical or clinical background; Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management Desirable: Advanced degree within the field; Professional certification; Understanding of multiple aspects within Study Management Key Relationship to reach solutions: Internal (to AZ or team): Study management function; Other AstraZeneca employees External (to AZ): External service providers and regulatory bodies Why AstraZeneca? At AstraZeneca we re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We re on an exciting journey to pioneer the future of healthcare. 02-Jun-2025 14-Jun-2025

Manager, Investigator Payments - India, Chennai - Hybrid, Office-Based Hybrid role (2 home-based day per week possible/3days per week in ICON Chennai offices) At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. We are seeking Managers to join our Investigator Payment (IP) team. As a Manager, you will be expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Key responsibilities include: People - Leadership, Teamwork, Energising and Developing Others Ensure all necessary training is provided to your direct report to improve their job performance and knowledge. Maintain/deliver a positive environment within Investigator Payment Group so that staff can grow and flourish *Assess the needs of the IPG group and liaise with senior management towards allocating the necessary resources to ensure optimal group performance Ensure that all members of the IPG team feel appreciated and that their contribution to the IPG team is valued. Take corrective measures where an IPG member s performance falls below the required standard Clients - Delivery to Customers, Building Relationships Maintain positive, strong working relationships with clients, vendors and staff. Communicate effectively with IPG s stakeholders and clients so that their expectations can be managed accordingly while also ensuring that they continue to receive the highest standards of service from IPG. Provide IPG input into the development of proposals and costings, participate in Bid Defence and pre-selling meetings as required Function as a key, senior level liaison for ICON with clients, as appropriate. Ensure the department and its staff operate in a professional, service-orientated and client orientated manner Performance - Personal Effectiveness, Commercial Awareness, Robust Thinking Drive/contribute to process improvement initiatives within IPG and in the wider organisation - including documentation of the processes changes in SOPs/WPs etc Drive system performance, compliance & change within IPG Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Manager, Investigator Payments - India, Chennai - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Hybrid role (2 home-based day per week possible/3days per week in ICON Chennai offices) At ICON, it s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives. Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That s our vision. We re driven by it. And we need talented people who share it. If you re as driven as we are, join us. You ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you ll be helping shape an industry. We are seeking Managers to join our Investigator Payment (IP) team. As a Manager, you will be expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Key responsibilities include: People - Leadership, Teamwork, Energising and Developing Others Ensure all necessary training is provided to your direct report to improve their job performance and knowledge. Maintain/deliver a positive environment within Investigator Payment Group so that staff can grow and flourish *Assess the needs of the IPG group and liaise with senior management towards allocating the necessary resources to ensure optimal group performance Ensure that all members of the IPG team feel appreciated and that their contribution to the IPG team is valued. Take corrective measures where an IPG member s performance falls below the required standard Clients - Delivery to Customers, Building Relationships Maintain positive, strong working relationships with clients, vendors and staff. Communicate effectively with IPG s stakeholders and clients so that their expectations can be managed accordingly while also ensuring that they continue to receive the highest standards of service from IPG. Provide IPG input into the development of proposals and costings, participate in Bid Defence and pre-selling meetings as required Function as a key, senior level liaison for ICON with clients, as appropriate. Ensure the department and its staff operate in a professional, service-orientated and client orientated manner Performance - Personal Effectiveness, Commercial Awareness, Robust Thinking Drive/contribute to process improvement initiatives within IPG and in the wider organisation - including documentation of the processes changes in SOPs/WPs etc Drive system performance, compliance & change within IPG Benefits of Working in ICON: Our success depends on the quality of our people. That s why we ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Purpose: Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly. The purpose of the Scientific Communications Associate - Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to protocols, protocol amendments and addenda and ICFs). 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. 1. Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration. Conduct effective document initiation meeting to ensure authoring team alignment and understanding. Build scientific-based rationale that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner. Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. Coordinate expert/scientific reviews, collate reviewer s comments, adjust content of document as required based on internal/external input, and prepare final version. Ensure and coordinate quality checks for accuracy. Exhibit flexibility in moving across development and preparation of multiple document types. Influence or negotiate change of timelines and content with other team members. Work with internal and external experts to develop and prepare presentations. As needed, may build and manage relationships with vendors/alliance partners. 2. Project and Stakeholder management Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents. Build/communicate credible writing project timelines. Anticipate and mitigate risks to delivery Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. Effectively communicate project status to stakeholders 3. Knowledge and Skills Development Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. Maintain and enhance knowledge of regulatory guidelines and publication guidelines. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews. Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms. 4. Knowledge Sharing Provide coaching to others by sharing technical information, giving guidance, answering questions. Recognized for technical expertise in specific document development. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. Provide database and other tool (e.g., document management systems) expertise. Minimum Qualification Requirement: Bachelor s degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing. Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process). . .

Job Description 1 Review of Study related documents (Protocol, IB, ICD, SAPs, Tables, Listings, Figures (TLFs), medical coding reports, CSR, etc. ) 2 Review of mock and final TFLs, AE/SAE data, clinical study reports 3 Preparation of regulatory briefing books, submission dossiers, etc. 4 Provide/support responses for Site/EC/Regulatory queries for ongoing clinical development products 5 Assessment of protocol deviations, assessment of ongoing safely and efficacy data, evaluation of SAEs, training of the operations team on therapy area and protocol etc. 6 Providing exclusive literature search for products under evaluation for deciding strategies 7 Provide support for literature search/ data required for statistical analysis 8 Provide support for evaluation of 505(b)(2) applications, creating clinical development strategy and plans for FDA, EMA, PMDA etc. 9 Preparing/Providing support for clinical designs in light of current knowledge /strategies 10 Able to mentor team and guide clinical development strategy, medical monitoring and biostatistical activities Work Experience 4-6 years Education Graduation in Medicine or Medicine Post Graduation in Pharmacology or Pharmacology Competencies

Summary As a Regional Medical Lead, you ll drive medical strategy, evidence generation, and cross-functional collaboration to improve patient access and outcomes. Your expertise will shape clinical development and ensure innovative therapies reach those who need them most. About the Role Key Responsibilities Lead the development and execution of local medical strategies aligned with global and franchise objectives. Identify strategic drivers and shape the patient journey and stakeholder engagement plans. Co-develop integrated evidence plans and oversee local execution across the product lifecycle. Drive real-world evidence generation and support innovative study designs to improve patient outcomes. Provide expert medical input on pipeline programs, disease areas, and approved brands. Collaborate cross-functionally to ensure compliant and impactful medical and promotional activities. Represent Novartis in scientific forums, publications, and external stakeholder engagements. Support training, regulatory submissions, and governance of external funding and patient programs. Role Requirements Advanced degree in health sciences (MBBS, MD, BDS, PhD, or PharmD) as per local regulations. Minimum 1-2 years of experience in the pharmaceutical industry. Strong clinical and research background with knowledge of Good Clinical Practice. Proven ability to translate scientific knowledge into strategic medical plans. Excellent communication, collaboration, and stakeholder engagement skills. Strong planning, organizational, and scientific writing capabilities. Fluency in English; proficiency in local language preferred. Desirable Requirements Experience with innovative study designs such as randomized controlled trials combined with real-world evidence. Proven track record of co-creating and executing protocols with healthcare system stakeholders. Why Novartis: You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Summary -Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Major accountabilities: Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output -Translate business requirements into logical models and provide direction to the development team to translate business logic. Lead authoring of the user requirements document, functional specifications and functional testing scripts -Proactively identify or address needs for optimal data review working with users and programmers as appropriate. Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner. Provide coordination between the project resources so that deadlines are met on deliverables. Drive development of appropriate user training. Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely execution of of projects & data requests -Feedback from project sponsors and key stakeholders -Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs Minimum Requirements: Work Experience: Functional Breadth. Cross Cultural Experience. Managing Crises. Collaborating across boundaries. Operations Management and Execution. Skills: Automation. Biostatistics. Clinical Trials. Computer Programming. Metadata Management. Statistical Analysis. Languages : English. Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a critical role in influencing regulatory decisions, managing complex global submissions, and ensuring successful product development, approval, and market access for FME s product portfolio. The Global Strategy Leader will work closely with internal and external stakeholders to align regulatory strategies with business objectives and drive the timely delivery of high-quality pharmaceutical products. PRINCIPAL DUTIES AND RESPONSIBILITIES: Regulatory Strategy Leadership: Lead the development of global regulatory strategies for the company s pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. Collaborate with senior leadership in medical/clinical development, commercial, and other functional areas to align regulatory strategy with overall product development and business objectives. Provide expert guidance on regulatory requirements, market access strategies, and potential risks to inform decision-making across the organization. Global Regulatory Submissions: Oversee the planning, preparation, and execution of global regulatory submissions to ensure timely approval and market access across key regions (e.g., FDA, EMA, Health Canada, etc.). Including global chemistry, manufacturing, and controls writers and authorship Ensure the integration of regulatory considerations into all stages of product development, including preclinical, clinical/medical, CMC, and post-market phases. Monitor regulatory trends, updates, and guidance from global agencies, ensuring the company s strategies remain aligned with changing regulatory requirements. Cross-Functional Collaboration & Stakeholder Management: Serve as a regulatory contact for cross-functional teams, ensuring alignment on regulatory strategy and execution across global markets. Work closely with commercial, clinical/medical, and manufacturing teams to ensure timely and successful regulatory approval of products, addressing any regulatory challenges that arise. Lead interactions with regulatory agencies and stakeholders worldwide to advocate for regulatory positions, influence decisions, and expedite approvals. Regulatory Risk Management & Compliance: Identify and manage regulatory risks associated with the global development and commercialization of pharmaceutical products. Ensure compliance with local and global regulatory standards, including FDA, EMA, ICH, and other regulatory bodies, to maintain market access and product integrity. Develop and implement strategies to address potential regulatory roadblocks or challenges, ensuring the company remains on track to meet business goals. Team Leadership & Development: Lead, mentor, and develop a high-performing team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement. Build and maintain strong, productive relationships with global regulatory authorities and external stakeholders, such as consultants, regulatory agencies, and industry groups. Provide leadership in managing global regulatory submissions, ensuring efficient and high-quality execution. Market Access and Competitive Intelligence: Assess and anticipate the competitive landscape and market trends to inform the regulatory strategy and market access plans. Utilize market intelligence and regulatory data to optimize product lifecycle management, regulatory strategy, and portfolio prioritization. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 10 - 15% domestic and international travel required. EXPEREINCE AND REQUIRED SKILLS: Education: Bachelor s degree in Life Sciences, Pharmacy, Chemistry, or a related field (Advanced degree such as a Master s, PhD, or MBA is highly preferred). Regulatory Affairs Certification (e.g., RAC) is preferred. Experience: 12+ years of experience in regulatory affairs, focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. Proven experience in leading global regulatory strategy for complex pharmaceutical products across multiple regions (FDA, EMA, HC, etc.). Strong expertise in navigating regulatory pathways for drug strategy, from preclinical through post-market. Demonstrated success in leading and mentoring a team of regulatory professionals in a fast-paced, global environment. Experience managing large-scale global regulatory submissions, including IND/CTAs, NDAs, NDSs, and MAAs, etc.. Skills & Competencies: Strategic thinker with a deep understanding of the global regulatory environment and pharmaceutical industry trends. Exceptional leadership and team-building skills, with the ability to manage and inspire cross-functional teams. Strong project management skills, with a proven track record of delivering regulatory submissions on time and within scope. Excellent communication, presentation, and negotiation skills, with the ability to influence senior leadership and regulatory agencies. Analytical mindset, capable of identifying risks and proposing solutions to address regulatory challenges. Proven ability to navigate complex regulatory landscapes and deliver strategic solutions that drive product success.

Senior Financial Analyst - India, Chennai - Hybrid INSERT ADVERT TEXT HERE Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

Senior Financial Analyst - India, Chennai - Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development INSERT ADVERT TEXT HERE What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

About ProcDNA: ProcDNA is a global consulting firm focused on establishing Commercial Analytics and Technology solutions for life science firms. We work side by side with our clients, partnering to achieve their goals. Our people bring in a strong blend of design thinking, the latest technology, and a client-centric approach to create a lasting impact. For a firm starting right at the onset of the pandemic, we had stellar growth from 20-24. We grew from 2 - 275+ people and are continuing with rapid but organic growth. Each one of us at ProcDNA (ProcDees) boasts about a healthy blend of learning, new opportunities, and growth which gives a feeling of swimming in the open waters rather than confining ourselves to a single lane. We invite you to join us and be part of our growth journey. What we are looking for: We are looking for a Research Analyst to join our team. You are someone who has a good understanding of competitor monitoring, conference coverage, market assessments, company/ asset profiling, therapy area newsletters and able to relate it with real-world problems What you"ll do: Provide support to projects in the areas of competitor monitoring, conference coverage, market assessments, company/ asset profiling, therapy area newsletters etc. Working closely with Consultants and Sr. Consultants manager and upwards in adding value through secondary data collection and writing summaries for clinical and business events (periodic newsletter, news alerts) Discuss the findings, updates and any highlights with the clients and working in close collaboration with them. Develop periodic market landscape/ competitive landscape reports. Progressively elevate the ability to judge the relevancy of data to the project. Carry out in-depth analysis; primary and secondary research to analyze various industries; uses the data gathered during the research to carry out the market, customer, and vendor analysis. Must have: 0-1 years of experience in competitive intelligence (pharmaceutical preferred) Btech/BE/ME (CS/IT/Biotechnology/Any Graduation with relevant experience) or BEcon Good understanding of pharmaceutical business from commercial and clinical development perspectives, of global pharmaceutical environment and challenges Proficiency with M.S. Office, Google, LinkedIn, etc., and relevant secondary research tools. Good comprehension ability, Impeccable attention to detail and QC abilities Updated with all the recent developments in the pharmaceutical space and specifically in the areas of focus. Ability to think critically, work independently and follow instructions. Ability to work collaboratively within a team both in the office and off site. Good organizational, time management and priority setting skills, and the flexibility to multi-task in a fast-paced environment. Excellent written and verbal English skills.

Senior Client Services Associate - Office or Home - India ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Client Services Associate, PCS to join our diverse and dynamic team. As a Senior Client Services Associate, PCS at ICON, you will play a pivotal role in managing and enhancing our client relationships within the Patient and Clinical Services (PCS) sector. You will ensure exceptional service delivery, address client needs effectively, and contribute to the overall success of our client engagements through proactive support and coordination. The position involves leading and preparing complex client-focused proposals, budgets, and contracts for new business opportunities. The role requires strategic coordination across departments to ensure timely and high-quality proposal submissions aligned with business needs. Key responsibilities include chairing kick-off meetings, setting project strategies, liaising with sales and operational teams, negotiating with US/EMEA/APAC clients, and actively contributing to process development and initiatives. What You Will Be Doing: Adhere to the MRT department-specific proposal process Chair kick-off and resource meetings and coordinate the participation of appropriate personnel in the proposal development process Set-up and lead project strategy meetings for key/non-key opportunities Liaise with the appropriate personnel including sales, strategic proposal development and operations throughout the proposal generation to ensure that the proposal and strategy meets the business needs in line with triage priority Prepare costs for proposals by interacting with operational departments to coordinate costs and assumptions Submit final proposal, on time, to client Coordinate and participate in negotiations and discussions with clients as required Lead single service bid difence and other client meetings as needed. Support other Client Services and BD staff in multi-service bid defences. Coordinate and prepare budgets and specifications for contracts for new business awards (where appropriate) Clarify contract specifications with the Manager, CCS, Project Manager; and/or Account Manager/Executive (where applicable) Solicit input and review of proposals, budgets and contracts (where applicable) from the relevant operational departments Train and mentor junior staff as appropriate and as designated by Manager Develop and maintain filing and tracking tools in accordance with accepted practices Comply with ICON administrative, training and human resources policies Assist with continuous departmental process improvements and participate in special projects periodically assigned, in addition to day-to-day duties Your Profile: Expertise in eCOA and COA Licensing Strong technical background in clinical technologies Proficiency in Microsoft Office tools Ability to adapt to change and competing priorities Strong collaboration, organizational skills Excellent work autonomy Excellent written and verbal English communication skills #LI-KT1 What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply