177 Clinical Development Jobs - Page 5

Oversee safety issues of projects conducted by ICON which will include, but not be limited to, the following: Adverse event reporting to the sponsor Follow up of adverse events as necessary Communication of safety issues to the head of the department or designee Participate in the on-call system for providing 24/7 medical support Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following: Medical information source Ongoing training for project teams in therapeutic areas as requested Review of study documentation (protocol, CRF. etc.) Contribute to investigator meeting presentations Ongoing safety review of individual patient laboratory reports generated by central laboratories CRF safety review Contribute any necessary medical input into integrated clinical and statistical reports Assist in making presentations to potential clients when appropriate Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention Line management of DSAs as appropriate

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

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

Manager - 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

Alvotech is looking to hire a Clinical Development Lead who will play a pivotal role in the strategic planning and preparation of Clinical Development Plans (CDP) for assigned clinical programs. As a clinical expert, this role supports Clinical and Medical Affairs Group in interactions with external stakeholders such as regulatory authorities, key opinion leaders, data monitoring boards, and advisory boards, as well as internal stakeholders including CMA, GRA, and Device Development. The Clinical Development Lead is responsible for ensuring state-of-the-art scientific input into all relevant clinical and regulatory documents for assigned projects. Additionally, this role involves thorough review, interpretation, and presentation of clinical trial data for further discussions, both internally and externally, in collaboration with Medical Leads. Scope & Responsibilities: Lead preparation and review of clinical documents (protocol synopses, protocols, clinical trial reports, IMPD sections, IB). Ensure scientific excellence in clinical development strategy, trial designs, and regulatory documents. Lead the preparation of Clinical Development Plans (CDP). Provide high-level scientific input for safety reports, briefing documents, INDs, NDAs, and other regulatory submissions. Offer clinical/scientific input during clinical trial development and execution, including data review activities. Contribute to study documents (e.g. SAP, DMP). Interpret clinical trial data. Lead interactions with regulatory authorities for clinical development discussions. Participate in or provide input for independent monitoring committee meetings. Maintain up-to-date training records. Stay current with ICH-GCP requirements. Job Requirements: Education : Minimum Master s degree in life sciences or equivalent. M.D., Pharm.D., Ph.D. strongly desired. Experience : 5+ years in relevant roles within the Pharmaceutical Industry. Scientific Background : Strong background in pharmacology, immunology and/or oncology preferred. Biosimilars/Biologicals Experience : Prior experience with biosimilars or biologicals essential. Language Skills: Fluent in English (written and verbal). Additional languages are a plus. Leadership and Interpersonal Skills : Strong leadership, participation, and team contribution skills, with the ability to build team spirit, communicate openly, and share knowledge. GCP Knowledge : Deep understanding of GCP and GxP. Technical Skills : Proficient with Microsoft Office (Word, Visio, Excel, PowerPoint). What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.

The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company s core therapeutic areas in all phases of clinical development. Our vision is to be an industry-leading organization driving essential communication excellence to achieve successful submissions and approvals. The Clinical Regulatory Writing Manager is expected to: With limited guidance, lead author and ensure the timely delivery of high-quality clinical-regulatory documents. Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and standard methodology are applied. Have the ability to balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities. Drive the clinical interpretation of data and information and condense it into clear, concise and accurate messages that address customer information requirements. Provide critical review of documents for correctness, clarity, completeness and compliance. Proactively collaborate with other functions during document development, including, as needed, with external service providers/contractors. As part of a clinical delivery team, provide communications support to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency. Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Clinical Regulatory Writing on drug and non-drug projects, as required. Work independently but with the guidance and support of more senior members of the group. Essential Skills/Experience Life Sciences degree in an appropriate subject area. Experience in medical communications. Strong communication and leadership skills. Knowledge of the technical and regulatory requirements related to the role. Desirable Skills/Experience Advanced degree in a scientific discipline (Ph.D). Experience of medical writing in the pharmaceutical industry and understanding of communication development in projects.

Medical Writer I - India, Bangalore - Office or Home-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 Medical Writer I to join our diverse and dynamic team. As a Medical Writer I at ICON, you will play a pivotal role in the development and preparation of clinical trial documents, regulatory submissions, and scientific publications, contributing to the advancement of inNvative treatments and therapies. What you will be doing Collaborating with cross-functional teams to prepare, write, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents in compliance with internal standards and regulatory guidelines. Conducting literature reviews, data analysis, and interpretation of clinical trial results to support the development of scientific manuscripts, abstracts, posters, and presentations for publication in peer-reviewed journals and scientific conferences. Assisting in the review and validation of clinical data, ensuring accuracy, completeness, and consistency with study protocols, standard operating procedures (SOPs), and regulatory requirements. Participating in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, and deliverables, while providing input and feedback on document content, format, and presentation. Keeping abreast of emerging trends, scientific developments, and regulatory updates in relevant therapeutic areas, and applying kNwledge of medical writing principles and best practices to support the successful execution of clinical research projects. Your profile Bachelors degree in Life Sciences, Pharmacy, Medicine, or related field, with a keen interest in medical writing, clinical research, and drug development processes. Excellent written and verbal communication skills, with the ability to translate complex medical and scientific information into clear, concise, and engaging content tailored to diverse audiences. Strong attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously, prioritize workload effectively, and meet project deadlines in a fast-paced environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with document management systems, reference management software, and statistical analysis tools preferred. Demonstrated ability to work collaboratively as part of a multidisciplinary team, communicate effectively across different functional areas, and adapt to changing project requirements and priorities. Motivated self-starter with a passion for learning and professional growth, committed to delivering high-quality work and contributing to the success of clinical research initiatives. 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.

Main purpose of the Job: To provide inputs and/or assist the Head Clinical Development in development of clinical programs across indications involving vaccine candidates. Provide inputs to all aspects of product development including, synopsis and protocol design, conduct of clinical trials, implementation and monitoring; as well as data interpretation and reporting. Role & responsibilities Support the Head - Clinical Development in Strategizing Clinical Development of investigational vaccines to move into early phase of clinical trials. Provides input and/or support the Head in the design, planning, initiation and completion of clinical trials. Coordinate with Preclinical, CMC/Quality and Clinical teams with respect to product development. Responsible for the preparation of study protocols, Clinical dossiers and other regulatory submissions including publications. Assist in the execution of the assigned clinical trial and/or clinical program in partnership with other line functions including medical associates, statisticians, trial managers where applicable. Attend appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events.

As a Site Contract Analyst II at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start Up Team Lead in developing and executing the plan for country and site distribution. Your expertise and dedication will be essential in efficiently conducting SSU (Study Start Up) activities in the assigned countries, ensuring the smooth initiation and progress of clinical trials. What you will be doing Efficiently Drive Study Initiation: review and negotiate clinical site investigator contracts and budgets. Maintain communication with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents. Reviewing and analysing contracts, agreements, and legal documents related to clinical trial activities and vendor relationships. Negotiating contract terms and conditions with clients, vendors, and other stakeholders to ensure compliance with regulatory requirements and company policies. Collaborating with cross-functional teams to assess contract risks, identify opportunities for improvement, and develop strategies to mitigate potential issues. Maintaining accurate and up-to-date records of contract status, milestones, and deliverables using contract management systems. Providing guidance and support to internal teams on contract-related matters, including contract interpretation, compliance, and dispute resolution. Your profile Bachelors degree in Business Administration, Legal Studies, or a related field; advanced degree or certification in Contract Management or a relevant discipline preferred. Minimum of 2 years of experience in contract administration, contract management, or a related field, preferably in the pharmaceutical or clinical research industry. Strong understanding of contract law, legal terminology, and regulatory requirements related to clinical trials and vendor agreements. Excellent analytical and problem-solving skills, with the ability to evaluate complex contractual issues and propose effective solutions. Strong attention to detail and organizational skills, with the ability to manage multiple tasks and prioritize work effectively in a fast-paced environment.

Perform all surveillance activities including periodic report production, leading monthly signal-detection activities, and SIRC activities for established products. Author/provide strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Produce high-quality and timely responses to safety queries. Identify and use appropriate sources of information and database searches to retrieve relevant data for evaluation of signals for all products in your area of responsibility. Foster a culture devoted to growth and achievement. Raise appropriate concerns/issues to senior staff in a timely manner. Lead the Safety Strategy and Management Team (SSaMT) for established products. Perform end-to-end pharmacovigilance activities independently on established products. Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures. Provide strategic and scientific input into regulatory authority submissions, queries, and discussions. Support responses to queries/impositions by regulators, with a high level of attention to implications in other countries. Ensure good communication and guidance to AZ products. Essential Skills/Experience Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety (pharmacovigilance)/clinical development. Comprehensive understanding of applicable Patient Safety regulatory obligations in the EU. Awareness of Patient Safety policies, processes, and procedures. Awareness of medico-legal aspects of patient safety. 4 to 7 years of Patient Safety experience (with clear evidence of delivery). Total of 7 to 10 years of experience. Desirable Skills/Experience Ability to work effectively as a member of a cross-functional or distributed team. Ability to work with autonomy. Ability to acquire and assimilate knowledge in different fields, disease, and therapeutic areas. Good communication skills with the ability to work across cultures. High ethical standards, including a commitment to AstraZeneca values and behaviors. Ability to appreciate diversity and work as equals with global and cross-functional teams. Communication: Well-developed interpersonal skills. Cultural sensitivity. Ability to network with other functions globally

We are currently seeking a Software Trainee as part of our Technology team, the role will include responsibility for: Monitoring DocFlow for upcoming reports and assigning as appropriate to an Aggregate Data Management Specialist. Refreshing preliminary tables at DLP-45 and sends to the client PSSR authors Receiving requests for tables from client Communicating with the requestor to get clarity on Table Requests Answering questions on table generated from requestor Generating all the requested data tables Quality control and peer QC of data table Uploading tables into GDMS Informing PSSR Authors that the data tables are available in GDMS Creating aggregate case lists after the report was submitted to the agencies Learning and maintaining a working knowledge of data table generation systems and tools and how these are applied On-going liaison with PSSR Authors to ensure data table standards and deadlines for delivery are met Recording of key information (including workflow) to support delivery of metrics Adhering to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved Desirable Skills and Experience 0-1 years experience Knowledge in OOP concepts and design principles Excellent verbal communication Good team player Awareness of latest computer technology

10+ years of pharmaceutical competitive intelligence experience Very good understanding of pharmaceutical business from commercial and clinical development perspectives, of global pharmaceutical environment and challenges Possess expertise in 1-2 therapy areas to work as an SME Highly proficient in using Microsoft suite (Excel, PowerPoint and Word) and build visually appealing business reports Proficient in using pharmaceutical databases (Citeline, Trial trove, Factiva etc.) and the ability to judge their appropriate application to the project/business needs Strong analytical skills to grasp problems (complexity, context etc.), see the big picture, conceptualise out of the box solutions Superior communication skills to ensure that the scope of projects/initiatives and expectations are commonly understood Excellent writing and comprehension ability, impeccable attention to detail and QC abilitiesGood organizational, time management and priority setting skills, and the flexibility to multi-task in a fast-paced environmentAbility to interface with cross-functional teams on a sound clinical and commercial base Education Qualification:M. Pharm/M.Sc./MBBS/Ph.D/MBA

Designation: Research Scientist - Document Reviewer Job Location: Bangalore Department: Clinical Development About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve Rproductivity, speed up time to market and lower the cost of innovation. Job Purpose: The position holder is responsible for document review related to Bioanalysis, including Pharmacokinetics and Immunogenicity. Key Responsibilities: Review technical documentation and record review in a report Provide assistance/participate for the preparation of SOPs etc. Execution of review documents in accordance with planned timelines Technical data reviews for studies utilizing analytical skills, technical knowledge and utilizing excellent regulatory guidelines requirements Capable to focus attention to detail review and identify critical observations Routine review of laboratory log books, equipment calibration and validation status etc. Handle multiple studies data review simultaneously in an efficient and effective manner. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: Master s degree in Biological Sciences (Preferably Biochemistry background) or a related field. Technical/functional Skills: Good knowledge of MS Office applications is necessary Handling audits and participation in audits is preferable Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. Experience: 12-15 years of total experience in Document review. Behavioral Skills: Should be independent. Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

-Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. -Applicable to Clinical Scientific Expert IThe Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned. Job Description Major accountabilities: Implementing issue resolution plans; -Assist with program level activities (e.g., tracking of program -Managing interactions with relevant line functions including data management, drug supply management, clinical development and/or Novartis Country Pharma Organizations; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans. Applicable for Clincial Scientific Expert I: -Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready. High quality contributions to study documents (e.g. protocol, ICF, clinical sections of CTA) -Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Clinical Research. Clinical Trial Protocol. Clinical Trials. Data Integrity. Learning Design. Lifesciences. Risk Monitoring. Trends Analysis. Languages : English. Skills Desired Clinical Research, Clinical Trial Protocol, Clinical Trials, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis

Internal/extrernal stakeholders, project team members, vendors Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents (e. g. , statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 3 years programming experience in industry recommended. For US positions: US military experience will be considered towards industry experience. Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs. Understanding of clinical data structure (e. g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e. g. , MS office, XML. Demonstrated ability in the handling and processing of upstream data, e. g. , multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e. g. , ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Preferred Requirments: Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical development Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience in other software packages (e. g. R) Experience with the Linux operating system IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs. iqvia. com

Department - Clinical Reporting Unit Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment. The position The key responsibilities in this position will be to perform medical writing tasks of high complexity and act as project manager. Plan, develop and oversee regulatory documents across all phases including but not limited to preparation of Protocols, Clinical Trial Reports (CTRs), non-interventional study reports (NSRs), Meeting packages and briefing book, Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries and Clinical overviews (NDA/MAAs). In this position, you need to lead, set direction, drive discussions, ensure decisions are taken and influence and implement project strategy. You will have to communicate the clinical data in a clear and concise manner. You will contribute to process improvements, knowledge sharing, skill building, and mentor and train other medical writers as needed. You will have to maintain good relationship with the stakeholders and colleagues. Ensure timely, clear, and proactive communication and collaboration with the stakeholders and colleagues globally. Assume role as Project Medical Writer (PMW), Clinical Submission Team Lead (CST) for assigned project. Responsible in order to meet timelines, the medical writer must be good at planning own work and be proactive when problems arise and seek help and advice from relevant people within GBS as well as within HQ. Support execution of Clinical Reporting strategy and vision in line with the leadership team. You will challenge the expert contributors on the clinical documents where the quality of their written contribution could be improved. Qualification You are expected to have the below skills and knowledge: Graduate (PhD, MSc., M Pharm, or equivalent). 10+ years of experience as medical writer or other relevant work experience. Experience in regulatory medical writing, Clinical study Report (CSR), protocol, IB, informed consent and clinical summaries and clinical overviews. Excellent understanding of clinical development and regulatory processes and requirements. Experience working within a global setting. Experience from the pharmaceutical /CRO industry. Strong understanding of external requirements related to regulatory documents. Strong analytical skills. Excellent communication and presentation skills. Committed, persistent and accountable. Able to handle numerous tasks simultaneously. Requires good communication and analytical skills. Demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc. Established record of being a proactive team-player and able to deliver on time and with high quality.