177 Clinical Development Jobs - Page 6

Department: Medical Affairs HQ BLR, GMA-BLR This position is responsible for managing a team of global medical advisors executing GMA deliverables for Diabetes (Insulin and GLP-1 areas). In specific, this position is directly responsible for owning the medical strategy and GMA activities across focus areas for GMA-BLR accountable products within Diabetes (LCM products including modern and new generation insulins, Semaglutide and other relevant products under transition). The position The position holder will be anchored to Medical Affairs HQ BLR GMA-GBS department. People management: Lead and manage team of Global Medical Advisors in Medical Affairs HQ BLR GMA-BLR. Strategic direction setting and management of the Global Medical Affairs deliverables: Responsible for ensuring the timely, accurate and credible building of scientific and medical knowledge for relevant products in Diabetes (Insulins and GLP-1 RAs), across medical affairs focus areas and towards internal and external stakeholders. Executing on the below deliverables at a managerial level, demonstrating Subject Matter Expert status: Generation, Interpretation & Communication of scientific data to ensure proper usages of NN products. Clinical importance of new findings and impact in future and current treatments of diabetes. All activities are to be executed and considered on a Global scale, resulting in high impact on Regions & Affiliates. People management: Manage and develop team - set direction, develop skills set, coach and guide the team. Resource planning and prioritization of department tasks, to ensure optimal and flexible use of resources, and monitoring and reporting of department performance. Set targets for the team and follow up on deliverables; delegate responsibilities and assignments. Manage processes for performance management and individual development plans (i.e. performance management, job descriptions, development discussions, input to organizational development planning (ODP), talent management and succession planning). Drives development of the team and individuals by seizing and creating opportunities related to actual business needs. Coaches and mentors team members to be strong contributors within the department and unit. Identifying and manages people related challenges proactively: Flags peoples related issues to manager in time, aligns on course of action, provides and documents timely constructive feedback. Proactively creates and maintains an engaged culture in the team. Ensures progress and improvements through evolve follow-up. Contribute to setting direction for Medical Affairs HQ BLR department and ensure that the business targets for the department are met. Identifies and drives continual improvement initiatives in team and department. Ensures success of department by driving strategic initiatives at Medical Affairs HQ BLR department level. As member of GMA-BLR people managers, drives continual improvement and contributes proactively to setting direction for GMA-BLR and ensure that the business targets for the unit are met. Strategic direction setting and management of the Global Medical Affairs deliverables: Functional management Proactively leads and drives according to Novo Nordisk Way a team of Global Medical Advisors, and is responsible for the medical affairs input and actions to the Medical & Science Team (MST), Safety Committee and Product Labelling Committee (PLC), GPT and Core Brand Teams. Responsible for prioritizing cross-organizational collaboration (R&D, CSCA, GS, affiliates). In alignment with area VP, responsible for developing the global medical affairs strategy incl. publication strategy in alignment with the brand strategy set by the CCT/GPT Budget responsible for project and line budgets. Guidance and coaching of team members and creates a culture of continuous development of team to meet functional requirements. Develops team members to take on more strategic and complex responsibilities Strategic and proactive collaboration with Therapy area leads (Directors, Sr. Directors and VPs) to ensure alignment on expectations, feedback and areas for value creation Contributes to and gives input to therapy area strategy and participates in TA leadership discussions, flagging challenges and highlights from GMA-BLR related products/projects. Clinical activities: (Insights for strategy, Evidence generation, Clinical care pathways) Responsible for cross-project and portfolio alignment and timing of clinical activities, specifically in relation to planning of communication strategy Provide market oriented medical input to trial design and protocol development and PDP Develop ISS strategy included in LCM plan/ PDP. Ensure continuously updated overview of in- and external clinical activities for specific product/project. In alignment with area VP, develop and secure implementation of strategic directions for relevant products. Responsible for Investigator Sponsored Studies (ISS) coordination, progress and budgets. KOL Engagement: (Scientific dialogue, Insights for strategy, Evidence generation) Independently drives the strategy, development and execution of scientific communication during high quality global meetings (e.g. scientific expert meetings, symposia etc.) Gather and analyze medical and scientific feedback, e.g. from KOL interactions in advisory boards and secures dissemination to relevant internal stakeholders. Signs off on and drives the development and execution of scientific story line, content, topics of global advisory boards and ensure that necessary feedback loops within the organization are established to operationalize insights. Publication Planning: (Scientific dialogue) Responsible for cross-project alignment and timing of strategic publication planning, specifically in relation to scientific publication of key data milestones. Drive development and execution of publication plan and strategy for each product/project in collaboration with the Global Publication Manager Overall responsible for the content of assigned publications (posters, abstracts, manuscripts) including frequent interactions with authors, statisticians, medical writers, and other stakeholders in collaboration with the Global Publication Manager Ensure high quality publication in a timely manner according to the medical communication strategy Ensures generation of scientific evidence to support medical and product strategy Scientific and medical education: (Scientific dialogue) Responsible for cross-project alignment and timing of strategic medical education, specifically in relation to scientific publication of key data milestones and direction of key scientific points Signs off on and drives the development and execution of scientific story line, content, topics of medical education activities Support development of and execute strategy for medical education activities for each product/project (CME and non-CME) Execute global medical education and medical communication plan to ensure KOL/HCP recognition and understanding of clinical profile of compound through presentations of data and participation in meetings and symposia Clinical activities: (Insights for strategy, Evidence generation, Clinical care pathways) Responsible for cross-project and portfolio alignment and timing of clinical activities, specifically in relation to planning of communication strategy. Provide market oriented medical input to trial design and protocol development and PDP Develop ISS strategy included in LCM plan/ PDP. Ensure continuously updated overview of in- and external clinical activities for specific product/project In alignment with area VP, develop and secure implementation of strategic directions for relevant products Responsible for Investigator Sponsored Studies (ISS) coordination, progress and budgets Internal Medical guidance: (Organizational readiness) Proactively secure alignment of relevant cross-functional business activities on specific product/project Ensures appropriate development of promotional materials initiated by Global Marketing, specifically aligns the story line based on existing medical strategy and newly generated scientific data Ensures resources for reviewing and approving medical content of promotional material in accordance to SOPs Take active role in providing medical support to legal issues that arise from competitor complaints or other associated channels Medical/scientific support to Public Affairs and/or Market Access in negotiations with payers/policy makers for specific product/project. Support execution of global marketing strategy Independence and decision-making: Works independently and has proven leadership skills: The Manager is expected, based on solid experience, to act and work independently according to NN Standard Operating Procedures and Global Medical Affairs strategy and complete all task outlined in the job description plus ad-hoc assignments, Degree of independent decisions: High level of independence in decision making The Manager represents GMA with his/her presence and statements in cross-functional forums as assigned, including GPT and/or Core Medical Team. It is also within the role to be stand-in for the VP and organise selected tasks across the team. The Manager is extensively expected to be able to make decisions and set direction on behalf on Global Medical Affairs when it comes to matters within the job description The Manager acts as Subject Matter Expert for all products covered in his/her department and leads the timely, accurate and credible building of scientific and medical knowledge within the project including internal training. The Manager must drive and maintain communication to and from the external scientific community (including to provide medical and scientific support for key opinion leaders and HCPS) and within the organization. Communication and Stakeholder interaction: Key Internal Stakeholders: Medical Affairs (Medical Directors other Regional heads, MedAff HQ, National Medical Advisors, Field Medical Force) Marketing, Sales. Global Development Public Affairs, Regulatory and Quality. Global Medical Affairs management Brand and area Global Project Team (GPT)/ Lifecycle Management Team Core Brand Team (CBT) Local and international Health Care Professionals and Influencers (local and global Opinion Leaders) Medical, scientific and patient organizations Medical communication agencies. Qualifications M.D. with substantial clinical and/or research expertise in relevant area (e.g. Endocrinology, Cardiology, General Practice or Internal Medicine) Strong clinical and/or research background in area of diabetes mellitus with interest in advanced scientific analysis and communication and experience in drug development. Understanding of the pharmaceutical industry. Fluency in both spoken and written English. Demonstrated research experience (e.g. publications) Additional education and experience in pharma business/marketing (preferable) Minimum one year of study or work in a country other than the native country (preferable) Additional education/scientific degree in research (e.g. PhD) (preferable) At least 10 years of clinical and/or pharmaceutical industry experience. At least 7-8 years of experience in a leadership role. Experience with clinical medicine, clinical research and development. Willingness to coach colleagues and support team development. Ability and willingness to quickly adjust to new situations in a continuously developing environment Ability to engage and collaborate with people with different backgrounds (science, business, etc) Excellent presentation skills. Strategic mindset.

JOB DESCRIPTION Designation: Senior Executive- Electrical Job Location: Hyderabad Department: Engineering and Projects. About Syngene Incorporated in 1993, Syngene International has grown to become a major player in the contract research and manufacturing services domain. Syngene supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation and analytical development along with Clinical development services. Syngene specializes in research and manufacturing of small molecules and large molecules for organizations around the world. The Companys facilities are audited and certified by health authorities from India, the USA, EU, United Kingdom and Russia, amongst others, for GMP related activities. Job Purpose: Involving in Facility, utilities, equipment Electrical Installation and qualifications in Manufacturing and development facilities for Syngene s Hyderabad operations. Key responsibilities: Planning, Monitoring and controlling of Day-to- Day project activates in Projects and engg. . Planning day-to day activities in accordance with the schedule. Follow up with field coordinators and vendors and ensure the tasks are completed as planned. Coordination with Consultants for GFCs . Involving in review and execution of utility and facility DQ, FAT, SAT and IQ OQ. Follow up with project related vendors and monitoring work relating to HVAC, GDS ,clean rooms, Electrical, IT, paneling, Utilities etc. Understanding, reviewing changes to the drawing related to Electrical works -Electrical , HVAC, Clean utilities, Plant Utilities, Layouts etc. Execution of facility and equipment commissioning and qualification of Syngene Compliance. Job analysis Preparation/Review, issuing field clearance as required. Ensuring Housekeeping at project site. Collaborating with Engineering cross functional for carry out field duties. Involving in URS creation and vendor technical evaluation for utility and facility in collaboration with engineering cross functionals. Ensuring Training compliance. Ensuring facility and equipment commissioning and qualification of Syngene Compliance in collaboration with the Quality department. Adhering to the company s established processes and rules and ensuring that the team does as well. Compliance with SOPs, cGMP and EHSS standards. Updating on day to day activates and subsequent plan with reporting manager. Educational Qualification: BE/BTech in Mechanical/Electrical Engineering . Diploma in electrical engineering Technical/Functional Skills. Good knowledge on Pharma/Biotech industry environment. Knowledge in GMP sterile facility quality system (DI, Deviation and change management). Knowledge in guidelines like ASME- BPE, EU GMP, ISO 14644, ALCOA principle. Bioprocess/Sterile operations will be plus. AutoCAD skills will be plus. Possess the knowledge and exposure to EHSS practices. Experience.: Overall 7-10 year of industry experience out of which 5 years of relevant manufacturing facility construction and management experience required. Good knowledge in CRO Industry . Good knowledge in cleanroom and Biosafety levels. Bio process/Sterile industrial experience is preferable. Behavioral Skills. Good in communication (written/oral) in English. Collaborative team player Growth mindset, positive approach. Quick learner. Equal Opportunity Employer: Syngene will not discriminate against any employee or job candidate based on age, color, physical ability, ethnic origin, nationality, religion, gender, family status, marital status, pre-natal status, gender reassignment, or sexual orientation, either directly or indirectly. We shall make appropriate accommodations for eligible workers or job candidates with disabilities wherever possible.

-Oversees all operational aspects of clinical trials end-to-end including the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations -Complete oversight of budget and resource allocation within assigned trial Drives operational excellence through process improvement and knowledge sharing across trials within program/franchise Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs Point of escalation for resolution of trial management operational issues within assigned trial -Applicable to Clinical Scientific Expert Group Head:The CSE Group Head (CSE GH) supervises Clinical scientific experts (CSE I/ CSE II) Responsible for competency building of the team by coaching the Clinical Scientific Expert The CSE GH facilitates their allocation across Development Programs/ Brands for planning and tracking all activities pertaining to one or more Development Programs/ Brands Responsible for allocating/ balancing resources aligning with Clinical Development Functional Heads (CD-FH), Global Program Clinical Heads (GPCH), Therapeutic Areas Heads (TA Heads) and based on the Development Unit/portfolio needs Major accountabilities: Responsible for the planning, executing and implementation of operational strategy of assigned clinical trial(s) Develops materials for trial -related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations. Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. Contributes to the global initiatives (e.g., process improvement, training, SOP development, other line function initiatives). Contributes to talent and career development of associates through on -boarding, coaching, and/or mentoring support. 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: Excellence in execution and implementation of clinical operations strategy -Timely, efficient and quality execution of assigned trial and trial related activities within budget, and in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans. Cost effective management of budget and resources with limited unforeseen cost overruns. Applicable to Clinical Scientific Expert Group Head: -Strong leadership skills to be able to support management in team competency building, lead/contribute to local/global initiatives and best practice sharing across programs and/or departments -Efficient, quality-driven, timely delivery of quality documents to support Clinical Development activities by the team in compliance with international and local regulations and Novartis internal standards. Accountable for, review and updates resource needs for programs ensuring support to the portfolio. Timely delivery of program activities within the group to achieve critical milestones. Clearly anticipate and communicate risks. Cost effective management of budget and resource management within the CSE group. Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity. Work Experience: Organization Scope; Scale and Complexity. People Challenges. People Leadership. Skills: Budget Management. Clinical Research. Clinical Trial Protocol. Clinical Trials. Coaching. Cross-Functional Teams. Data Analysis. Learning Design. Lifesciences. Risk Management. Risk Monitoring. Languages: English.

Registered Nurse is required along with two or more years of relevant work experience in drug development or clinical industry. Excellent critical thinking skills Should have clinical research experience Data Management experience is a plus Experience working with FDA regulations and reporting requirements and experience working with the MedDRA dictionary is preferred. Experience working with electronic data (eCRFs), Microsoft Office Applications and other electronic data capture and transfer methods is highly desirable. Excellent verbal and written communication skills. Must be detailed oriented and possess excellent organizational skills. Ensures timely collection of documents and components of Adjudication Packages for Clinical Endpoint Committees to allow quality and complete adjudication of potential clinical endpoints occurring in clinical trials. Collect, QC and ensure that the package content is medically complete and appropriate to allow physician adjudicators the ability to apply objective endpoint definitions to each case presented to them. Must have knowledge of and adherence to all applicable aspects of Good Clinical Practices, Federal Regulations, International standards and company SOPs is required. Will construct medically complete and logical adjudication dossiers for presentation to physician adjudicators. Also responses to queries from Physician adjudicators, Clinical Site Personnel, Company Personnel as it relates to collection of dossier components. Will be responsible for, in collaboration with project management, generating status and progress reports for committees and tracking performance and quality among adjudicators. They will also work with Project Management and Clinical Operations to generate all necessary committee documentation, preparing periodic reports and reviews of certain cases, identify potential sources of un-blinding, extract Endpoint/AE data from various source documents and spontaneous sources. Manages case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries and ensure proper coding (MedDRA) into the Clinical Endpoint Committee database.

Registered Nurse is required along with two or more years of relevant work experience in drug development or clinical industry. Excellent critical thinking skills Should have clinical research experience Data Management experience is a plus Experience working with FDA regulations and reporting requirements and experience working with the MedDRA dictionary is preferred. Experience working with electronic data (eCRFs), Microsoft Office Applications and other electronic data capture and transfer methods is highly desirable. Excellent verbal and written communication skills. Must be detailed oriented and possess excellent organizational skills. Ensures timely collection of documents and components of Adjudication Packages for Clinical Endpoint Committees to allow quality and complete adjudication of potential clinical endpoints occurring in clinical trials. Collect, QC and ensure that the package content is medically complete and appropriate to allow physician adjudicators the ability to apply objective endpoint definitions to each case presented to them. Must have knowledge of and adherence to all applicable aspects of Good Clinical Practices, Federal Regulations, International standards and company SOPs is required. Will construct medically complete and logical adjudication dossiers for presentation to physician adjudicators. Also responses to queries from Physician adjudicators, Clinical Site Personnel, Company Personnel as it relates to collection of dossier components. Will be responsible for, in collaboration with project management, generating status and progress reports for committees and tracking performance and quality among adjudicators. They will also work with Project Management and Clinical Operations to generate all necessary committee documentation, preparing periodic reports and reviews of certain cases, identify potential sources of un-blinding, extract Endpoint/AE data from various source documents and spontaneous sources. Manages case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries and ensure proper coding (MedDRA) into the Clinical Endpoint Committee database.

The Associate Director of Biostatistics is a member of cross-functional Development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the Associate Director of Biostatistics can have responsibilities for supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the Biostatistics indication/asset Lead, and other cross functional team members. Key Responsibilities Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols. Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents Presents summary data and analyses results, in a clear, concise, complete, and transparent manner Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design. Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable Contributes to external and internal statistical community of practice Develops & advises team members Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. Applicable to people managers Effectively engages as an employee advocate and management coach/mentor to team members - both internally and externally Provides leadership to empower and develop the team. Provides guidance to employees development plans and carries out performance review and feedback. develops performance metrics for staff. Qualifications & Experience PhD (6+ years experience) or MS (8+ years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation. Great interpersonal, communication, writing and organizational skills Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework Good understanding of regulatory landscape and experience with participating in regulatory interactions Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills People manager experience is preferred (for people manager position only)

Responsibilities: Assist the bidding team with proposal pre-work, including gathering feasibility, pricing, and other required data. Support documentation, system updates, and internal coordination Requirements: 1-3 years of experience in bid coordination, proposal writing, or a related role, preferably in healthcare market research. Strong attention to detail. Proficiency in MS Office (Excel, Word, PowerPoint). Ability to multitask and work under tight deadlines. As part of job responsibilities, you are required to comply with ISO 20252:2019 and ISO 27001 standards .

Organization Overview: The purpose of the Associate, GSC Clinical Trial Registry Writing is to support the development and implementation of Clinical Trial Registry (CTR) systems and processes, ensuring Global transparency regulations and requirements are described and implemented and that there are monitoring systems (and metrics) in place to ensure compliance. The CTR writer will collaborate with cross-functional, multidisciplinary teams across multiple geographies and phases of drug development to ensure/coordinate the accurate and timely posting of applicable clinical trial protocol information and study results. Responsibilities: Clinical Trial Registry and Results Planning, Development, Finalization and Document Management Contribute to the development, maintenance, and implementation of policies and/or procedures on clinical trial registry and clinical trial results database processes and work flows. Identify opportunities for process improvements. Identify studies required for registry and results postings. Ensure that responsible functions are aware of timelines and deadlines. Collaborate cross functionally with applicable team members and departments (e.g.,biostats, medical, clinical trial management), to obtain data required for completion of registry and results entries. Manage access rights to applicable systems as needed. Serves as subject matter expert on CTR database requirements. Develop and provide education and training as required to internal groups. Define and monitor applicable metrics to support overall compliance. Maintains and enhances knowledge of CTR regulations and guidelines. Exhibits flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc. Project Management / Influence / Knowledge Sharing Supports the systems and process for CTR and works with other team members to ensure consistent practices are monitored and employed globally. Provides input to deliver innovative solutions, preventing re-occurrence of issues. Escalates issues in a timely and appropriate manner. Ensures the evaluation (monitoring) of the CTR processes and communicating changes to the processes to the business. Shares key learning to drive simplification and replicate best practices. Basic Requirements: Bachelor s degree in scientific, health, communications, or technology related field Or, Bachelor s degree in any field with at least two years of clinical development experience. Demonstrated high-level end-user computer skills (MS office applications: Word, Excel, PowerPoint, etc.). Demonstrated mastery of English language skills written and spoken. Additional Skills/Preferences: Experience with CTR processes and databases. Experience in biostatistics, medical/regulatory writing. Verbal reasoning, attention to detail, critical thinking, and analytical ability. Demonstrated project management and time management skills. Ability to be flexible in varying environments and with multiple customer groups. Able to work independently as well as part of a team: able to take initiative and responsibility, following through and completing assigned tasks. Able to deal with ambiguity and to plan, prioritize, and manage conflicting priorities. Experience working within multiple functional areas across medical, regulatory and legal. Strong interpersonal and negotiation skills - Ability to manage upwards. Strong medical research background with demonstrated breadth and depth of knowledge of medical research processes throughout all phases of development. Developed networks and proven ability to influence cross-functionally at all levels. Ability to influence/lead others. Ability to work well across cultures and time zones.

Investigator Payments Coordinator - India, Chennai - Office-Based, 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 The role: Oversee and be accountable for the quality of the payments in the studies assigned to them to ensure they are conducted in an effective manner, meeting agreed timelines and expectations and in accordance with Investigator Payment Group (IPG) KPIs, WPS and SOPs, appropriate regulations and ICON s quality standards. What you will be doing: Liaise with all other ICON departments such as Clinical, Contracts, IT, Finance and Legal to ensure payment queries are speedily resolved and that the necessary preventative measures are put in place to prevent recurrence of similar issues. Update IPG systems with any changes from site contracts for assigned studies, as applicable. Communicate effectively with investigative site personnel and/or ICON or Sponsor Clinical Project Managers, regarding payment inquiries and managing their expectations accordingly as required. Respond to site queries in agreed timeline. Reach out to the sites directly for any open items, build positive relationship with sites. Contribute to the IPG group by seeking to continuously improve their job performance and knowledge of IPG systems and processes. To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract Prepare communication materials/ payment data for internal/ external clients relating to investigator payments/reporting as appropriate Review payments in line with site contracts and visit data to ensure sites are being paid in a timely accurate and efficient manner and escalate delays/ issues appropriately. What you will need: Minimum of 2 years relevant work experience preferred. Ability to liaise successfully with all levels of management at ICON, sites, and stakeholders. Good working knowledge of PC applications (Excel, Word and Outlook). Oracle knowledge is an added advantage. Good knowledge of financial reconciliations Excellent organizational, administration and problem-solving skills with strong attention to detail and accuracy. Excellent written and verbal communication skills. Candidate should be ambitious, able to multi-task work well under pressure Ability to work to tight deadlines 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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

Investigator Payments Coordinator - India, Chennai - Office-Based, 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 The role: Oversee and be accountable for the quality of the payments in the studies assigned to them to ensure they are conducted in an effective manner, meeting agreed timelines and expectations and in accordance with Investigator Payment Group (IPG) KPIs, WPS and SOPs, appropriate regulations and ICON s quality standards. What you will be doing: Liaise with all other ICON departments such as Clinical, Contracts, IT, Finance and Legal to ensure payment queries are speedily resolved and that the necessary preventative measures are put in place to prevent recurrence of similar issues. Update IPG systems with any changes from site contracts for assigned studies, as applicable. Communicate effectively with investigative site personnel and/or ICON or Sponsor Clinical Project Managers, regarding payment inquiries and managing their expectations accordingly as required. Respond to site queries in agreed timeline. Reach out to the sites directly for any open items, build positive relationship with sites. Contribute to the IPG group by seeking to continuously improve their job performance and knowledge of IPG systems and processes. To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract Prepare communication materials/ payment data for internal/ external clients relating to investigator payments/reporting as appropriate Review payments in line with site contracts and visit data to ensure sites are being paid in a timely accurate and efficient manner and escalate delays/ issues appropriately. What you will need: Minimum of 2 years relevant work experience preferred. Ability to liaise successfully with all levels of management at ICON, sites, and stakeholders. Good working knowledge of PC applications (Excel, Word and Outlook). Oracle knowledge is an added advantage. Good knowledge of financial reconciliations Excellent organizational, administration and problem-solving skills with strong attention to detail and accuracy. Excellent written and verbal communication skills. Candidate should be ambitious, able to multi-task work well under pressure Ability to work to tight deadlines 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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

The Position The position holder will assist closely in providing strategic and medical guidance covering portfolio of products and functionally be a part of Medical affairs team. He/she will execute on the below deliverables demonstrating Subject Matter Expert status: PDP process - Actively playing the role of PDP Secretary, Driving the PDP process at regional level Generation, Interpretation & Communication of scientific data to ensure proper usages of NN products Clinical importance of new findings and impact in future and current treatment of diabetes, obesity, rare diseases & OSCD Deliver timely accurate and credible scientific medical guidance across medical affairs focus areas towards internal and external stakeholders Management The management aspect of this job is to ensure effective collaboration between medical affairs teams Acts as a liaison between Novo Nordisk and Key Opinion Leaders Manage the application and communication of all Novo Nordisk policies, procedures, according to the Novo Nordisk Way Is the global specialist on a specific product/project towards internal/external customers Ensures coordination, within team, of content development and related tasks in relation to meetings/events initiated by Medical & scientific affairs team. Supports manager in recruiting and onboarding new colleagues. Broad exposure to all areas and close interactions to higher organizational levels Broad impact through developing/planning of guidance and scientific material development used in areas of the business towards advancing our products. Be go-to person for colleagues for scientific questions PDP Circulate PDP & specific questions to PDP Forum & relevant BA/Affiliates* Coordinate and schedule the meetings (WG, Affiliates and Forum) Consolidated input & identification of discussion points Communication Transforming clinical trial data into scientific and commercial communication, used to scope/plan the support of our products and provide early market access Communication to broad range of stakeholders: Patients, Primary and Secondary Health Care Professional, high level global Key Opinion Leaders, Advisory Boards and Scientific Experts KOL & Association Engagement Develop and maintain strong relationships with Global Key Opinion Leaders Provide input, develop, and execute on global Health Care Professional strategy Plan, conduct and execute meetings plus support speakers in preparation for presentation of NN data at conferences and symposia Design and contribute to and execute on Health Care Professional strategy Proactively plan and engage in scientific dialogue and relationships with global Key Opinion Leaders Expand and develop new relationships to relevant upcoming Key Opinion Leaders to allow the company to benefit from different viewpoints Gather and analyze medical and scientific feedback, from global Key Opinion Leader interactions in advisory boards and conversations at meetings and conferences Drive the development and execution of scientific story line, content and topics of global advisory boards and ensure that necessary feedback loops within the organization are established to operationalize insights Develop, drive, and execute on scientific communication during high quality global meetings (e.g., scientific expert meetings, symposia etc.) Medical Guidance Take responsibility for developing a broad range of medical guidance documents and the needed digital solutions (e.g., e-learnings) to be used by affiliates Drive alignment of relevant cross-functional business activities on specific product/project Provide medical affairs support to legal issues that arise from competitor complaints or other associated channels Medical/scientific support to Public Affairs and/or Market Access in negotiations with payers/policy makers for specific product/project Extract insight from evidence and external input and transfer it into new medical claims Execute training to support key markets/regions/affiliates. Conduct live training at global training events Sufficient portfolio insights and business understanding to give input to e.g., Marketing and Market Access strategies Involved in providing Medical education with medical guidance to external audience too. Communication and Stakeholder interaction: Key Internal and External Stakeholders: Medical Affairs in International Operations, Regions & Affiliates Global Medical Affairs HQ Field Medical Force Marketing Global Development Public Affairs Regulatory and Quality Global Safety Qualifications M.D. with substantial clinical and/or research expertise in relevant area (e.g. Endocrinology, Cardiology, General Practice or Internal Medicine) Strong clinical and/or research background in area of diabetes mellitus with interest in advanced scientific analysis and communication and experience in drug development Understanding of the pharmaceutical industry. Fluency in both spoken and written English Demonstrated research experience (e.g. publications) At least 2 years of clinical and/or pharmaceutical industry experience Experience with clinical medicine, clinical research and development

You will be part of a fast-growing PE-backed business that allows high-performing employees to make an impact and contribute to growing the business. You will have the chance to channel your experience into supporting the development and commercialisation of portfolios, assets and brands by integrating therapeutic, clinical and commercial expertise to ensure that clients are able to make confident decisions. You will be responsible for supporting Competitive Strategy engagements across our clients product and company life cycles, and for growing revenue within existing accounts. As your clients will be global, the Associate Consultant position requires a thorough understanding of the evolving biopharmaceutical market and trends. Knowledge of drug development and commercialisation is also desirable. Key Responsibilities Evidence Generation: Secondary Data Analytics: Source, analyse and report published information, be it scientific, clinical, commercial, corporate or regulatory Primary Research: Collect market, competitor and stakeholder evidence through desk-based interviewing and elicitation Market Analytics: Evaluate business models, clinical development strategies, market dynamics and competitor threats through qualitative KOL interviewing and other methodologies Analysis and Reporting: Collaborate with other members of the project team to analyse findings, develop insights and implications and create client presentations that deliver a linear, evidence-based story on the topics in focus Project Management: Execute projects under the guidance of other members of the project team Client Management: Collaborate with other members of the project and account teams to ensure that clients experience best-in-class customer service and that projects are run in a proactive, communicative and efficient manner Subject Matter Expertise: Act as a valued subject matter expert externally, and mentor junior staff internally Required Experience and Skills One or more of the following advanced degrees in the life sciences: PhD; MTech (biotechnology or related areas); MPharm; MSc/MBA combination; MBBS More than 4 years of relevant professional experience from within the pharmaceutical or biotechnology industry, academia or consultancy organisations, of which at least 2 were focused in oncology and/or immunology and/or biosimilars consulting Confident communication skills to communicate messages clearly both within the project team and with clients on a peer-to-peer basis and to provide subject matter expertise Proficiency in the use of Microsoft Office applications, especially PowerPoint and Excel Fluency in English

About the job Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and RD, Data Digital functions . SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, Global Market Access and Commercial organizations in Sanofi, Globally. Main responsibilities: SGH Manager Market Access (GMA) will be functionally aligned to Global global market access leads and will support execution of multiple activities Manage assigned projects in the assigned portfolio to plan and generate robust health economics and value-based evidence to maximize the value propositions from both a global and US perspective working within the Market Access tripod by working with Market Access and leads Global HEVA BPs Support global market access and pricing leads on Payer Value Proposition (PVP) - review PVP aligned with the cover value dossier (CVD), BOI [burden of illness] or any other Max documents in the assigned portfolio Support global market access and pricing leads on clinical trials HTA tracking to monitor the competitors data, monitor the competitor s HTA outcomes and monitoring landscape tracking in the assigned portfolio Support market access and pricing leads on briefing book development/updates, cover value prospectus (CVP) and competitor pricing (current and evolution) to track competitor pricing at launch and today and linking price revisions with HTA outcomes Support development of treatment and payer Landscape, track guidelines (and updates) providing landscape (current and upcoming competitors) for in the assigned portfolio Work on Landscape Literature review, review of competitor and secondary assessment Support on PRO/QOL landscape tracking to track available data from competitors in publications, vs. label, vs. regulatory approval, HTA assessment documents Support in Epi funnel estimates with lit review on potential new sources of data for epi estimates Support development of a 1 pager view for US PBMs and objection handlers Collaborate with Global HEVA to seek opportunities to innovate Market access/HEVA value identification, evidence generation and dissemination process/plan to increase the relevance and impact of HEVA evidence to ensure reimbursement decisions optimal access Create complex and specialized strategic content without supervision Develop and maintain TA expertise Develop and review content created by junior members Coach junior members People: (1) Develop and maintain effective relationships with key internal stakeholders including HEVA, Medical Affairs, Clinical Development, Commercial and Market Access (2) Constantly assist and provide effective feedback to Junior members in developing knowledge and sharing expertise (3) Work effectively with global Market Access and pricing teams across various time zones Performance: (1) Manage assigned projects in the assigned portfolio to plan and generate robust health economics and value-based evidence to maximize the value propositions from both a global and US perspective (2) Support on PVP reviewed PVP, Updates of Submissions documents (CVD, AMCP, BOI) or any other Max documents (3) Support on clinical trials HTA tracking to monitor the competitors data, monitor the competitor s HTA outcomes and monitoring landscape tracking in the assigned portfolio (4) Support on briefing book development/updates, CVP and competitor pricing (current and evolution) to track competitor pricing at launch and today and linking price revisions with HTA outcomes (5) Support development of treatment and payer Landscape, track guidelines (and updates) providing landscape (current and upcoming competitors) for in the assigned portfolio (6) Work on Landscape Literature review, review of competitor and secondary assessment (7) Support on PRO/QOL landscape tracking to track available data from competitors in publications, vs. label, vs. regulatory approval, HTA assessment documents (8) Support in Epi funnel estimates with lit review on potential new sources of data for epi estimates (9) Support development of a 1 pager view for US PBMs and objection handlers ( Process: (1) Develop complex Market access strategic evidence material (2) Build expertise in the field of Market Access for the assigned Therapeutic area (3) Manage core Market Access strategic evidence generation processes, templates, and products across the portfolio in accordance to the scientific and value messages aligned with CVD, the US AMCP dossier, and HEVA contributions as appropriate to other submissions (4) Accountable for adherence to the evidence generation guidelines and other standards relevant to Market access/HEVA evidence generation processes at SGH (5) Work with selected vendors/SGH within the region to deliver the required deliverables as per defined process as per the business need (6) Leverage advanced training delivery tools techniques thereby enhancing the effectiveness of training delivery (7) design an overall plan of action basis end-customers feedback improve course content and delivery Stakeholder: Work closely with HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs and Market Access global or local teams in regions/areas to identify evidence generation and dissemination needs and assist in developing assigned deliverables. Liaise with these teams to prepare relevant customized deliverables and ensure milestones and timelines are on track for assigned the projects About you Experience : 6+ years of experience in Market Access/HEOR for the pharmaceuticals industry, CRO or academia. Strong project management and analytical skills to translate clinical and economic information and messages into payer evidence strategies. Relevant training/ experience in health economics, public health, epidemiology, or other relevant health-related scientific discipline. Soft skills : Demonstrate effective communication, organizational and interpersonal skills. Able to work effectively as part of a multidisciplinary global teams. Able to work independently, but in concert with the direction provided by their management, in accordance with defined functional policies and precedents, budgetary guidelines, company values, ethics and applicable law. Ability to handle multiple projects across different therapeutic areas. Strong customer focus. Ability to work well in a cross-functional team. Understanding of the disease environment and the evolution of the market access landscape and implications for the business. Proven track record working successfully in a project/matrix-oriented environment. Excellent communication skills and ability to understand and present complex information in digestible ways for internal (e.g. senior management) and external audiences. Strong team spirit, sense of transversality, multicultural awareness, and ability to drive matrix teams. Technical skills : Robust understanding of reimbursement decisions to determine value drivers and how evidence is used in decision making and how it impacts various payers (e.g., providers, patients, health systems). Strong knowledge of methods and principles of health economics, health technology assessment (HTA) reviews and market access. Strong ability to systematically review available scientific evidence to identify clinical needs of the payer. Understands, creates, and applies relevant methods (e.g., observational data, post hoc analysis of clinical trials, meta-analysis, indirect comparison, etc..) to demonstrate product value potential and drives processes around the same Education : Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree Languages : Excellent knowledge of English language (spoken and written) Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com ! Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Job Description: 1. Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool. 2. Assess currently utilized quality documents and develop/modify business processes as needed. 3. Develop training materials and provide training. 4. Develop and implement a consistent process to produce KPIs 5. Work closely with PM to ensure that timelines are met. 6. Coordinate and lead SMC meetings Experience: 1. Experienced in signal detection tools and processes 2. Skilled in implementing new business processes and technology solutions for signal detection in clinical development 3. Experienced in LEAN methodology 4. Working knowledge of regulations related to signal detection (GVP Module IX). 5. Proven expertise working with FAERS and WHO-Vigibase data 6. Ability to review complex information to develop business related strategies for integration of clinical development data and real-world data in the signaling process 7. At least 2-3 years of pharmacovigilance experience, especially in signal detection and management. 8. Strong consulting experience 9. Excellent Excel/WP/PowerPoint and technical writing skills 10. Clinical experience a plus

Regional Medical Advisor THE OPPORTUNITY The RMA (Regional Medical advisor) will be a valued representative at our company working in the field to interact and engage key stakeholders. Our medical affairs team objective is to provide scientific expertise across their identified regions/products/therapy areas to these valued customers. WHAT YOU WILL DO: The RMA will have the following key responsibilities: Developing and implementing medical strategies: Scientific leader identification development and engagement to build regional, national or international relationships to contribute to understanding of diseases, scientific trends, practice guidelines, and treatment patterns in areas relevant to our business Support to the health care providers by providing accurate and up-to-date medical information Education, training and periodic medical updates to the commercial team as demanded Ensuring compliance with local regulations and industry standards in all medical activities Responsibilities and Primary Activities: Scientific Expertise: Developing and maintaining an in-depth understanding of the companys products, therapeutic areas, and relevant scientific research. Staying updated on the latest medical and scientific advancements, clinical guidelines, and treatment protocols. SL KDM Engagement: Building and maintaining relationships with Scientific Leaders (SLs), Key decision makers (KDMs) healthcare professionals, and academic institutions. Engaging in scientific discussions, presenting clinical data, and providing educational support to KOLs regarding the companys products and therapeutic areas. Support to medical strategy: In alignment with the line manager, provide strategic inputs, and expertise, to product management towards ethical promotion of assigned products Medical Education: Providing scientific and medical education to internal stakeholders, including sales teams, marketing teams, and other cross-functional colleagues. Collaborating with the Medical Affairs team to develop and deliver training materials, presentations, and scientific symposia. Scientific Exchange: Facilitating scientific exchange and knowledge transfer between the company and external stakeholders. Participating in medical conferences, advisory boards, and scientific meetings to gather insights, share data, and contribute to the scientific community. Clinical Data Communication: Interpreting and communicating clinical trial data, real-world evidence, and other scientific information to healthcare professionals, regulators, and other relevant stakeholders. Ensuring accurate and compliant dissemination of scientific information in accordance with regulations and company policies. Clinical Research: Provide medical support for local studies, including need-based visits to identify study sites Lead Investigator Initiated Trials Cross-functional Collaboration: Collaborating closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Marketing, and Market Access, to provide scientific input, support clinical trial design, contribute to regulatory strategies, and align on medical communication plans. Facilitate access to scientific leaders as appropriate. Support as well as own medical initiated projects in line with therapy area that would involve a strong stakeholder interface Provide scientific support to sales team Medical Information: Addressing medical inquiries and providing timely and accurate responses to healthcare professionals, patients, and other stakeholders. Ensuring that medical information materials, such as medical letters and FAQs, are up to date and compliant. Sales Force Training: Provide medical training to sales colleagues on the therapy areas assigned Assist in pre-launch and launch training to sales staff for new products. Compliance: Adhering to relevant legal, regulatory, and compliance guidelines, including the organizations code of conduct and industry-specific regulations. Ensuring all activities and interactions are conducted ethically and in compliance with applicable laws and regulations. Overall, RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviors: Consistently adhere to/demonstrate all company Values with focus on excellence Work in harmony with internal and external stakeholders WHAT YOU MUST HAVE To be successful in this role, you will have strong marketing skills as well as business capabilities Educational Background: A strong academic background in life sciences, such as a medical degree (MD), doctorate (Ph.D.). Other relevant degrees in biology, pharmacology, or related fields may also be considered. Industry Experience: 1 year experience in the pharmaceutical, biotechnology, or medical device industry is often preferred. This could include experience in clinical research, medical affairs, or related roles that have exposed the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise: Demonstrated knowledge and expertise in the specific therapeutic area relevant to the position. This may involve experience working on clinical trials, publications, or direct patient care in that therapeutic area. Scientific and Clinical Knowledge: A strong understanding of medical and scientific principles, including knowledge of clinical trial design, data analysis, and interpretation. Familiarity with relevant disease states, treatment guidelines, and emerging trends in the therapeutic area is also important. Communication and Relationship-Building Skills: Excellent interpersonal, communication, and presentation skills are crucial for a RMA role. The ability to effectively communicate scientific information to various stakeholders, including Key Opinion Leaders (KOLs), healthcare professionals, and internal teams, is essential. Analytical and Problem-Solving Skills: RMAs are often required to analyze complex scientific data, identify insights, and provide recommendations. Strong analytical and problem-solving skills are valuable for interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility: RMAs often work in dynamic and fast-paced environments, requiring the ability to adapt to changing priorities and work independently. Flexibility to travel frequently to engage with external stakeholders is also often required. Regulatory and Compliance Knowledge: Familiarity with relevant legal, regulatory, and compliance guidelines, such as Good Clinical Practice (GCP), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulations governing medical communications. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 04/20/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Senior Statistical Programmer II - India - Office or Home 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 Statistical Programmer II to join our diverse and dynamic team. As a Senior Statistical Programmer, you will lead and manage projects and program statistical analyses/reports, analyse datasets, tables, figures (or graphs), listings (TFLs) with an emphasis on CDISC ADaM programming. This role offers an opportunity to expand your skill-set and showcase your talent in an environment where progression is encouraged. What You Will Be Doing: You will lead/project manage multi-disciplinary teams on assigned projects. Be responsible for developing, maintaining and validating standard data structure and software. Design and write standard departmental macros that are maintainable, supportable, Well-documented programs which are user friendly and accessible. Monitor procedures for program development and validation and assist in the training of statisticians/programmers to ensure the development of data analysis skills. Your Profile: Bachelor s degree in a quantitative or scientific discipline or equivalent, with Master s degree or PhD preferred. 7+ years of experience must be relevant and have primarily been involved in creating and validating analysis datasets (CDISC ADaM standard preferred), Tables, Listings and Graphs. Knowledge of a wide variety of technologies. Professional leadership skills coupled with exceptional 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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

Principal Biostatistician, 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 Principal Biostatistician to join our diverse and dynamic team. As a Principal Biostatistician at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Serves as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies. Oversees statistical activities that support ICON s interactions with clients and regulatory agencies. Reviews and approves statistical methods sections of study protocols, statistical analysis plans and statistical input to reports. Prepares and approves research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients. Participates in bid defense meetings and makes presentations at marketing meetings with prospective clients. Your profile Masters degree or Ph.D. in Biostatistics, Statistics, or a related field with 10 or more years of biostatistical experience with Master s degree; 8 or more years required with Ph.D. Advanced knowledge of multiple statistical and therapeutic areas, the drug development process, and statistical programming practices and procedures. Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies. Effective written and oral communication skills with demonstrated leadership ability. #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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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 Statistical Programmer I - India - Office or Home 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 Statistical Programmer I to join our diverse and dynamic team. As a Senior Statistical Programmer, you will lead and manage projects and program statistical analyses/reports, analyse datasets, tables, figures (or graphs), listings (TFLs) with an emphasis on CDISC ADaM programming. This role offers an opportunity to expand your skill-set and showcase your talent in an environment where progression is encouraged. What You Will Be Doing: You will lead/project manage multi-disciplinary teams on assigned projects. Be responsible for developing, maintaining and validating standard data structure and software. Design and write standard departmental macros that are maintainable, supportable, Well-documented programs which are user friendly and accessible. Monitor procedures for program development and validation and assist in the training of statisticians/programmers to ensure the development of data analysis skills. Your Profile: Bachelor s degree in a quantitative or scientific discipline or equivalent, with Master s degree or PhD preferred. 6+ years of experience must be relevant and have primarily been involved in creating and validating analysis datasets (CDISC ADaM standard preferred), Tables, Listings and Graphs. Knowledge of a wide variety of technologies. Professional leadership skills coupled with exceptional 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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

Data Analyst II, 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 We are currently seeking a Data Analyst II to join our diverse and dynamic team. As a Data Analyst II at ICON, you will play a crucial role in analyzing complex datasets to support decision-making and enhance clinical operations and research processes. You will contribute to the advancement of innovative treatments and therapies by providing actionable insights and leveraging data analytics to drive performance across the organization. What You Will Be Doing: Conducting thorough data analysis to support clinical trial design and execution. Collaborating with cross-functional teams to identify opportunities for data-driven innovation and optimization within clinical research. Interpreting complex datasets to derive insights and inform strategic decision-making. Assisting in the development of data visualization and reporting tools to effectively communicate findings. Establishing partnerships with stakeholders to leverage data analytics and improve research outcomes. Your Profile: Bachelor s degree in Radiology and Life science. 1.5+ years of experience in different Imaging Modalities such as CT, MRI and more Strong analytical skills with the ability to translate data into actionable insights. Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams. 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job responsibilities Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required Qualifications What we re looking for Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills. Ability to read, write, speak and understand English.

Provide expert regulatory guidance and strategic advice to clients on FDA regulations, policies, and procedures related to drug, biologic, and medical device development and approval. Review and interpret FDA guidance documents, regulations, and policies to ensure compliance and facilitate successful regulatory submissions. Support clients in preparing and submitting regulatory applications, including INDs, BLAs, NDAs, 510(k)s, and PMA submissions, and provide guidance on regulatory strategy and submission content. Conduct regulatory assessments and gap analyses to identify potential issues and risks in regulatory submissions and provide recommendations for resolution. Assist clients in preparing for FDA meetings, including pre-IND, pre-IDE, pre-NDA/BLA, and pre-PMA meetings, and participate in meetings as a regulatory representative. Monitor regulatory trends, changes, and updates from the FDA and provide insights and recommendations to clients on potential impacts on their products and programs. Collaborate with cross-functional teams, including regulatory affairs, clinical development, quality assurance, and medical affairs, to ensure alignment on regulatory strategy and objectives. Serve as a liaison between clients and regulatory agencies, including facilitating communications, responding to inquiries, and addressing regulatory challenges and issues. Qualifications: Bachelors degree in pharmacy, biology, chemistry, or related field; advanced degree preferred. Minimum of 5 years of experience working at the FDA in a regulatory role, with expertise in drug, biologic, or medical device regulation. Deep understanding of FDA regulations, guidance documents, and regulatory processes related to drug, biologic, and medical device development and approval. Proven track record of successful interactions with the FDA, including experience in preparing and submitting regulatory applications and participating in FDA meetings. Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to clients and internal stakeholders. Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop strategies for mitigation. Regulatory affairs certification (RAC) or relevant professional certification (e.g., Regulatory Affairs Certification Board) preferred but not required. Ability to work independently and collaboratively as part of a multidisciplinary team, with a commitment to delivering high-quality regulatory support and guidance to clients.

. Our most valuable asset is our people . At ZS we honor the visible and invisible elements of our identities, personal experiences and belief systems the ones that comprise us as individuals, shape who we are and make us unique. We believe your personal interests, identities, and desire to learn are part of your success here. Learn more about our diversity, equity, and inclusion efforts and the networks ZS supports to assist our ZSers in cultivating community spaces, obtaining the resources they need to thrive, and sharing the ZS Life Science RD Technologist in Clinical development ZS life science RD team partners with client to discover and develop innovative medicines that improve patients lives. Our work spans across consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professional that are delivering RD programs, $100MM+ invested in RD data, analytics and technology assets and 100+ clients on RD programs. Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in the drug development. The Drug Development RD Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, data management, and analytics systems. Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. What You ll Do You will spearhead the design implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What You ll Bring Bachelor s degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Master s degree in business analyst, Engineering or Science preferred. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. Significant supervisory, coaching and hands-on project management skills. Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects. Willingness to travel to other global offices as needed to work with client or other internal project teams. In-silico, digital twin, and/or modeling experience. Perks Benefits: Considering applying To Complete Your Application: Candidates must possess work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.

Principal Biostatistician, 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 Principal Biostatistician to join our diverse and dynamic team. As a Principal Biostatistician at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Serves as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies. Oversees statistical activities that support ICON s interactions with clients and regulatory agencies. Reviews and approves statistical methods sections of study protocols, statistical analysis plans and statistical input to reports. Prepares and approves research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients. Participates in bid defense meetings and makes presentations at marketing meetings with prospective clients. Your profile Masters degree or Ph.D. in Biostatistics, Statistics, or a related field with 10 or more years of biostatistical experience with Master s degree; 8 or more years required with Ph.D. Advanced knowledge of multiple statistical and therapeutic areas, the drug development process, and statistical programming practices and procedures. Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies. Effective written and oral communication skills with demonstrated leadership ability. #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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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 Statistical Programmer II - India - Office or Home 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 Statistical Programmer II to join our diverse and dynamic team. As a Senior Statistical Programmer, you will lead and manage projects and program statistical analyses/reports, analyse datasets, tables, figures (or graphs), listings (TFLs) with an emphasis on CDISC ADaM programming. This role offers an opportunity to expand your skill-set and showcase your talent in an environment where progression is encouraged. What You Will Be Doing: You will lead/project manage multi-disciplinary teams on assigned projects. Be responsible for developing, maintaining and validating standard data structure and software. Design and write standard departmental macros that are maintainable, supportable, Well-documented programs which are user friendly and accessible. Monitor procedures for program development and validation and assist in the training of statisticians/programmers to ensure the development of data analysis skills. Your Profile: Bachelor s degree in a quantitative or scientific discipline or equivalent, with Master s degree or PhD preferred. 7+ years of experience must be relevant and have primarily been involved in creating and validating analysis datasets (CDISC ADaM standard preferred), Tables, Listings and Graphs. Knowledge of a wide variety of technologies. Professional leadership skills coupled with exceptional 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, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. 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

Summary Internal Role Title: Clinical Research Medical Advisor Location: Mumbai #LI-Hybrid About the Role: We are seeking a highly skilled and motivated Clinical Research Medical Advisor (CRMA) to join our team. The CRMA will be accountable for all country clinical or medical aspects associated with Development and prioritized Research programs/trials. This role involves providing clinical strategic and tactical leadership, optimizing clinical trial implementation, and ensuring adherence to safety standards and clinical data quality. About the Role Key Responsibilities: - Provide clinical development and indication expertise specific to the country/cluster. Validate study designs and make final decisions on clinical/medical trial feasibility. Contribute to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up. Provide clinical/medical expertise to clinical trial operations team members and clinical trial sites for IRB/EC interactions. Develop clinical/medical trial plans to ensure successful trial implementation. Provide robust indication, compound, and protocol training to the clinical operations team and externally as needed. Support and partner with internal stakeholders regarding clinical trials. Essential Requirements:- Scientific degree MD/M.B.B.S Ability to manage a study from the scientific/medical/clinical perspective. Demonstrated capability to problem solve and mediate complex issues. Effective leadership and communication skills. Agility to move quickly across different therapeutic areas and indications. Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice. Sound understanding of the overall clinical development process and ICH/GCP principles.