260 Clinical Development Jobs - Page 11

Manager - International Regulatory Lead Role NameManager – International Regulatory Lead (IRL) Department NameInternational Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to - optimize product development and regulatory approvals in International countries - develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

What you will do Let’s do this. Let’s change the world. In this vital role you will leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality results from the team. Roles & Responsibilities: Collaborate with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Managers and customers to define scope and value for new developments. Collaborate with Engineering and Product Management to prioritize release scopes and refine the Product backlog. Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and customers understand how they fit into the product backlog. Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and execute effective product demonstrations for internal and external partners. Maintain accurate documentation of configurations, processes, and changes. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree with 6 - 8 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience. Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in clinical development with technology. Experience with Agile software development methodologies (Scrum). Good communication skills and the ability to communicate with senior leadership with confidence and clarity. Experience in writing requirements for development of modern web application. Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA. Good-to-Have Skills: Demonstrated expertise in a clinical development domain area and related technology needs. Understanding of software systems strategy, governance, and infrastructure. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code, no-code test automation software. Technical thought leadership. Able to communicate technical or complex subject matters in business terms. Jira Align experience. Knowledge of Cloud Platforms (AWS, Databricks) and GCP regulations. Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The Principal Statistical Programmer ( Programmer ) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials. Responsibilities Exceed expectations and responsibilities of a Senior Statistical Programmer Understand and implement CDISC and other regulatory standards Follow internal SAS programming conventions Serve as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor Coordinate and ensure the accuracy and completeness of activities for assigned support programmers Create and maintain project timelines Design, develop, document and validate tools and macros to improve quality and efficiency of processes Prepare and review programming specifications for SDTM, ADaM and other derived datasets Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to: Analysis datasets (SDTM, ADaM, other derived datasets) Perform ad hoc analyses of current and legacy databases Review and provide input on case report form design Serve as a subject matter expert Train and mentor others in task execution Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs Develop department training materials and deliver trainings to the team Drive/facilitate/actively engage in department initiatives Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs Strong understanding of departmental and company procedures; ability to guide others on procedures Participate in the development and revision of department SOPs Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc. Additional Responsibilities Assist in the preparation and review of monthly financial reporting Promote visibility outside of the functional area and effectively interact cross-functionally and in industry Perform other duties as requested by management Qualifications: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree Minimum of 6 years direct SAS programming experience in pharmaceutical development or CRO environment Good knowledge of medical terminology and conduct and analysis of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.) Excellent oral and written communication skills, organizational skills, and attention to detail are required Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience. It is Advanced Clinical s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law. This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.

Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Relevant Years of experience 3 to 6 years. Perform PV literature surveillance assessment activities according to regulations and agreed processes. Timely production of key deliverables including but not limited to: - Screen and review literature search results (articles/abstracts/citations) for aggregate report inclusion and potential safety signal identification. - Maintain and document up-to-date product knowledge for literature evaluation. Participate in quality or continuous process improvement activities related to area of responsibility Discusses need for, and priority of safety related findings/ signal reviews with the SERM product specialists / SERM physician, communicate, escalate, and document the outcome of signal detection process. Analyse and discuss safety data results with the SERM product specialists/ SERM physician and other key stakeholders Know where to find relevant safety information on products. Familiar with aggregate reports (DSURs, PBRERs), Risk management activities (RMPs), labelling documents (GDS, DCSI) Demonstrate GSK values Job Related Experience: Pharmaceutical industry experience (e.g., drug safety (desired), regulatory, clinical development, medical affairs) Basic knowledge of post-marketing regulations applicable to drugs. Knowledge of the principles of causality assessment and the evaluation of safety signals. Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Working knowledge of key pharmacovigilance regulations and methodologies Basic knowledge of medical and drug terminology. Basic understanding of therapy areas of assigned products. Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology). Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation. Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities. Excellent English language skills - written and verbal particularly in scientific/medical terminology Ability to evaluate data and draw conclusions independently High attention to detail. Highly developed interpersonal, presentation and communication skills. Computer proficiency, IT skills, the expertise and ability to work with web-based applications High level of flexibility and ability to prioritize work

Image Data Processing Technologist _ Office Based _ Chennai/Trivandrum ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development . We are currently seeking an Image Data Processing Technologist to join our diverse and dynamic team. You will collaborate with cross-functional teams to enhance the efficiency and effectiveness of imaging data in clinical research. What you will be doing Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork as well as communicating in an open, balanced, and objective manner Verifying incoming documentation and data for GCP/HIPAA violations and responding according to outlined procedures in a timely manner to rectify them Preparing / loading / demographically reviewing data for analysis Managing and filing documentation associated with projects Identifying issues with received data and notify project specific sites, customers and internal staff following internal processes to open, monitor, and resolve queries May represent Incoming Data Processing in internal meetings Compliance with internal SOPs Your Profile: Bachelor s degree in radiologic technology, medical imaging, or a related field; relevant certifications preferred. 1 - 4 years of experience in medical imaging or related roles, preferably within a clinical research environment. Strong knowledge of imaging techniques and technologies, as well as regulatory guidelines governing imaging in clinical trials. Excellent organizational and problem-solving skills, with a keen attention to detail. Effective communication and interpersonal skills, with the ability to work collaboratively 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, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

Image Data Processing Technologist _ Office Based _ Chennai/Trivandrum . We are currently seeking an Image Data Processing Technologist to join our diverse and dynamic team. You will collaborate with cross-functional teams to enhance the efficiency and effectiveness of imaging data in clinical research. What you will be doing Maintain a positive, results-oriented work environment by building partnerships, modeling teamwork as well as communicating in an open, balanced, and objective manner Verifying incoming documentation and data for GCP/HIPAA violations and responding according to outlined procedures in a timely manner to rectify them Preparing / loading / demographically reviewing data for analysis Managing and filing documentation associated with projects Identifying issues with received data and notify project specific sites, customers and internal staff following internal processes to open, monitor, and resolve queries May represent Incoming Data Processing in internal meetings Compliance with internal SOPs Your Profile: Bachelor s degree in radiologic technology, medical imaging, or a related field; relevant certifications preferred. 1 - 4 years of experience in medical imaging or related roles, preferably within a clinical research environment. Strong knowledge of imaging techniques and technologies, as well as regulatory guidelines governing imaging in clinical trials. Excellent organizational and problem-solving skills, with a keen attention to detail. Effective communication and interpersonal skills, with the ability to work collaboratively with diverse teams. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

Customer Service Rep _ Office Based _ Chennai/Trivandrum 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 Customer Service Rep to join our diverse and dynamic team. As a Customer Service Rep at ICON, you will play a pivotal role in providing exceptional support to our clients and stakeholders, ensuring their needs are met and enhancing their experience with our services. What you will be doing Responding promptly to customer inquiries via phone, email, or chat Providing accurate information about our products, services, and clinical trial processes Assisting customers with order placement, account management, and issue resolution Liaising with internal teams to address customer concerns and escalate complex issues as needed Maintaining detailed records of customer interactions and transactions Your profile High school diploma or equivalent; bachelors degree preferred Proven experience in customer service or a related field Excellent communication and interpersonal skills Strong problem-solving abilities with a customer-centric approach Ability to multitask, prioritize, and manage time effectively What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. EMS (Executive Medical Summary) Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration. Conduct effective document initiation meeting to ensure authoring team alignment and understanding. Build scientific-based rationale that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner. Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. Coordinate expert/scientific reviews, collate reviewer s comments, adjust content of document as required based on internal/external input, and prepare final version. Ensure and coordinate quality checks for accuracy . Exhibit flexibility in moving across development and preparation of multiple document types. Influence or negotiate change of timelines and content with other team members. Work with internal and external experts to develop and prepare presentations. As needed, m ay build and manage relationships with vendors/alliance partners . Project and Stakeholder management Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents. Build/communicate credible writing project timelines . Anticipate and mitigate risks to delivery Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. Effectively communicate project status to stakeholders Knowledge and Skills Development Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. Maintain and enhance knowledge of regulatory guidelines and publication guidelines. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews. Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms. Knowledge Sharing Provide coaching to others by sharing technical information, giving guidance, answering questions. Recognized for technical expertise in specific document development. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. Provide database and other tool (e.g., document management systems) expertise. Minimum Qualification Requirements: Bachelor s degree in a scientific, health, communications, technology health related field . Demonstrated experience in technical/ regulatory scientific writing . Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process ) Other Information/Additional Preferences: Graduate degree with formal research component or in life sciences. Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields . Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Experience writing regulatory, clinical trial documents and/or publications Experience writing deliverables for Medical Affairs communications (slide decks, patient or HCP materials, etc ) Experience in clinical development, clinical trial process or regulatory activities . Demonstrated project management and time management skills. Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).

Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1:1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy. Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures. Contribute to the Country Medical Plan Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Execute certain medical plan activities as assigned. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers. Support Clinical Trial Activities Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management. Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document. Support HCPs in the ISR submission process as agreed with local medical management. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Contribute towards the Patient advocacy programs Support the implementation of the patient education programs in collaboration with the patient advocacy groups. Support the creation of patient education materials. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures Qualifications MBBS, MD, BDS, MDS 1-2 years of Field Medical experience in medical affairs is preferred. Candidates with experience in the Oncology and Haematology therapy area will be preferred. Languages Excellent English language skills - spoken and written. Experience And Knowledge Working in a scientific and/or clinical research environment Ability to work independently and act as a team player. Have an innovative mindset and approach. Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients. Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments. Disease area knowledge and an understanding of scientific publications Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts (Health economic and outcome research) is a plus.

Biostatistician I / II - India - Office Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Biostatistician I to join our diverse and dynamic team. As a Biostatistician II at ICON, you will play a pivotal role coordinating and supervising the work of biostatisticians and programmers, ensuring timely and high-quality deliverables for assigned studies. What you will be doing: Contribute to the design of case report forms with a focus on statistical aspects. Review study database structures, edit checks, and data management coding conventions to ensure data integrity. Prepare comprehensive statistical analysis plans, defining derived data and crafting statistical tables, figures, and data listings for clinical summary reports. Conduct statistical analyses to extract meaningful insights from research data. Interpret data and effectively communicate findings through result reporting. Collaborate on writing the statistical methods sections of integrated study reports. Your Profile: A Masters degree or higher in statistics or related field Demonstrated experience of 2+ years in statistics, biostatistics, or a related field within the pharmaceutical industry is required. Strong kNwledge of study designs and statistical analysis conventions in one or more therapeutic areas. Exceptional verbal and written communication skills and proficient computer skills. Strong familiarity with clinical trials methodology, regulatory requirements, statistics, and proficiency in statistical software packages, including SAS. Ability to translate clients needs into statistical practices and educate clients in the utilization of statistical methods, coupled with solid interpersonal and project management skills. #LI-KT1 What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the 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