Responsibilities Responsible for executing GRO Regulatory Data Analytics operations in line with Work Instructions and SOPs. Primarily will be Regulatory Data Analytics Service related to product registration data management (includes the procurement of data from source regulatory documentation which requires a thorough understanding of the structure and contents of a regulatory dossier, and a thorough understanding of the data structures applicable to registration data and the related system workflows). Operationally hands-on in terms of carrying out data management activities as an individual contributor. This will require a thorough understanding of the structure and contents of a regulatory dossier (i.e. will be fluent in navigating and understanding the contents of a dossier). Registration data management will require a thorough understanding of the registration data structures, workflows, and applicable work instructions etc. Perform Quality Control (QC) and data integrity checking, as part of the Regulatory Data Analytics operation, to confirm the accuracy and completeness of the Teva Global Registration database. Represent GRO Regulatory Data Analytics across the wider Global Regulatory Affairs community. Must be proficient at building effective working relationships with all stakeholder and customer groups. Responsible for providing effective business project contributions for projects focused on improving regulatory data quality, the provisioning of regulatory data for internal re-use via system integration, or the implementation of any business or technology change that impacts regulatory data or the regulatory technology landscape.     Qualification & Experience Required: Bachelor’s or master’s degree in Life Sciences or Information Technology. Preferred: MS in scientific or information technology discipline. Required: 1-3 years (Preferred experience in regulatory operations/affairs)  

Responsibilities Build and retain clientele enabling growth of business on a short- and long-term basis. Competes for all existing and new sales opportunities within prescribed market to meet or exceed targets. Gathers, analyzes and delivers information from the field to allow the company to develop strategies. Co-ordinate all issues with key clients between service, delivery teams and finance.   Qualification & Experience MBA with a bachelor’s degree in science. At least 12 years of experience in International Business Development from a Global Clinical Research Organization (CRO)  

Responsibilities Review / Approval of Nitrosamines related documents. Analytical Development Report, Method Validation Protocols and Reports. Nitrosamine risk assessment Review / Approval of Computer System Validation related activities in gALM. Release / Reject of batches manufactured for clinical study. Review / Approval of Qualification documents for new instrument/ equipment. Implementation of Corporate policies / standards at site. Review, evaluation and approval of QMS documents i.e. change controls / deviations / LIR / chromatographic errors etc. Review / approval of Investigations, CAPA, LIR in Trackwise system. Ensure CAPA actions based on the investigation root cause are identified and implemented. Preparation of trends for non–conformance. Self-inspection of various departments to check compliance with GxP, SOPs and applicable regulatory requirements. Compilation of Site Quality Council Report and presentation of data on monthly basis. Review of Risk Assessments, Quality Technical Agreements between Teva and various contract laboratories, Intra Company- Quality Technical Agreement (IC-QTA). Review / Approval of specifications, Method Validation Protocols / Reports, Method Transfer Protocols / Reports, ADR, PDR, Study Protocol / Reports etc. Perform audit of Contract Laboratories, Third party vendor in co-ordination with Subject Matter Expert. Support during regulatory and other inspections at site. Any other responsibilities assigned by Head of Quality       Qualification & Experience M Pharm/ B Pharm/ M Sc 10 plus years relevant experience in Quality & Analytics Must have experience in QMS.  

 Responsibilities Project Execution: as individual contributor, responsible for Building and exhibiting deep expertise on available data sets and supports data enabled decision making using data from external suppliers (JDI, JPM, DDD, etc.) in Japan and internal data for various other sources in Eli Lilly Japan Ensuring high stakeholder satisfaction through consistent delivery of high quality, timely and insightful outputs throughout analytics value chain on various objectives related to – Brand descriptive analytics and visualization to provide data-based insights on planning, measurement and segmentation e.g. Lilly brand performance, market monitoring, new brand launches, customer analysis OCE (omni-channel engagement) analytics, segmentation, targeting and campaign measurement etc. e.g. analysis on source of business, test and control, engagement segmentation, channel spend optimization, trade off analysis, etc. market intelligence reporting on KPIs related to sales, sales growth, wholesaler inventory, market share, market growth, sales force activity, P2P and non-personal channel promotional impressions and engagement metrics etc. data support through data mining and warehousing Developing into a trusted advisor by actively participating in various phases of the project including kick-off, methodology development, execution, insight generation and data visualization and results presentation to various stakeholders Participating in meetings with stakeholders and communicating the final outputs and recommendations   Project Delivery: as team member, supporting the team lead in driving quality, speed, value and compliance throughout the analytics value chain project management for seamless project execution, prioritization and high quality delivery creation and maintenance of standard operating procedures (SOPs), quality checklists that will enable excellent quality outputs shared learning forums to identify challenges and establish best practices expansion of analytical capability of the team by taking on more complex projects and delivering value process improvements and implementation of analytical best practices   Qualification &  Experience Degree in sciences or quantitative discipline i.e. Finance, Econometrics, Statistics, Engineering or Computer Sciences. Experience in pharma/healthcare industry is preferable. 4-6 years of analytics experience with demonstrated ability to think strategically in an ambiguous environment in analytics Experience in pharma industry is preferable  

Responsibilities Responsible/accountable for management/delivery of overall book of work for clinical Design -DDH Staff. Develops and executes sourcing plans in partnership with GSC leads to ensure seamless delivery of asset plan and priorities. Adjusts work plan based on shifting priorities using effective change control. Leads and directs internal and external team members in achieving team goals. Identifies and resolves issues affecting delivery of work. Conceives and implements new and efficient ways to accomplish goals. Regularly reports results of team activities to leadership and stakeholders.     Qualification & Experience Master’s degree in scientific, health, communications, technology, health outcomes, or public health related field. 8 years’ experience medical communication / pharmaceutical industry. Strong scientific communication skills, including extensive experience in writing/content development, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically.  

Responsibilities Performs data analysis, identifies business needs, defines requirements, documents processes and procedures, and advises on ways to be more efficient. Create new models based on understanding of how data-driven changes to process, products, services, software, and hardware can improve efficiencies and add value. Create detailed business analysis, outlining problems, identifying gaps in existing functionality, opportunities, and solution recommendations. Develop project or product rationale and perform scoping assessments to resolve feasibility. Develop a comprehensive requirement specification that will settle estimate of cost, time, and resources to deploy solutions Develop estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.). Ensure that relevant customers are involved in specification of new and/or major upgrades to existing services or products Ensure the overall user experience is at the center of the design for new solutions and services and support super user training Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support validation and testing as appropriate and ensure alignment to Security and Compliance policies and procedures within Service Delivery reach Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), TT Service Portfolio and with industry best practices in leveraging technologies for the business and taking advantage of reusable products, solutions and services wherever applicable.   Qualification & Experience At least 8 years of work experience in life sciences in business analysis or equivalent role Solid understanding of TechOps, Supply Chain, Quality and Finance processes and systems  

Responsibilities Responsibility for ensuring high quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT) Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review. Contributes to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study. In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools. Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools. May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications. May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. Produce training materials and provide training to iCTT.   Qualification & Experience Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master's, PharmD, M.Pharma, PhD, MBBS, BDS, MD strongly preferable. Fluent English (oral and written). >1 year experience in pharmaceutical industry/ clinical research organization - Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization. Work experience in clinical operations preferable. Strong interpersonal skills - Ability to work under pressure  

Responsibilities Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations Contribute to Module #1 documents including FDA forms and cover letters for maintenance/non-maintenance submissions with management oversight Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all Novartis requirements for submission-related activities Proactively identify issues, gaps, and trade-offs affecting optimal and timely submission. Independently manage US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable Independently manage the user fee registration requests. Independently manage and execute drug shipment ticket review process (US) In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc. Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities Where appropriate, participating in kick-off meetings for NDA/IND annual reports and QC of NDA annual reports from previous versions (US). Where appropriate, perform QC of approved label versus previous versions with adequate management oversight   Qualification & Experience Minimum of 3 years pharmaceutical experience with a minimum of 1-2 years of regulatory experience preferred. Prior publishing/Regulatory Operations experience desired. Good communication and negotiation skills.  

Responsibilities Responsible for development & tracking procedures, establishment and maintenance of service contracts and warranties with vendors. Be accountable for compliance to Lab and MEIC procedure including presenting required evidence during audit. Directs and coordinates the laboratory support staff for R&D Project Lab activities & support. Plans and execute preventative maintenance and calibration for lab requirements. Maintains an adequate inventory of materials, and laboratory equipment. Ensures effective operation of all laboratory equipment and serves as point of contact for instrument repairs. May organize and participate in vendor negotiations, product and software evaluations, tutorials, and facility modifications. Interfaces with Employee Health and Safety (EH&S) and acts as a liaison between departments and the scientific staff to complete lab modifications and ensure safety compliance. Provides technical input to purchasing and other functional areas. May trouble shoot and repair general instrumentation. Trains new scientific staff in the general use and function of designated instrumentation and creates and refines user protocols for general use. Be the single point of contact for stakeholder holder communication, maintain dashboards. Enable operational excellence & continuous improvement initiatives May have budget accountability for a department, function. Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms. Risk identification and mitigation Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem. Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties .   Qualification & Experience To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelors Degree in Biomedical, Chemical, Electrical, or other sciences related field and 10 + years of engineering lab / product development experience and 5+ years of leadership or managerial experience. OR Advanced Degree in Biomedical, Chemical, Electrical, or other sciences related field and 3+ years of engineering experience and 5+ years of leadership or managerial experience Prior work experience in a regulated industry (medical device, pharma, aerospace, defense) Experience working in a clean room environment or equivalent  

Responsibilities Understand the research question and scientific strategy (created by the Epidemiology Strategists and NIR Study Scientists) for which the literature review is being conducted. Review the published literature generated as a result of the search strategy and select the most relevant and scientifically sound studies from which to include information in the synthesized literature review. Extract the relevant epidemiologic data and other scientific information (e.g., specifics of the study designs and methodology) from the selected publications and populate epidemiology literature review templates Determine if additional search criteria should be applied to identify literature should be included in the review and apply such criteria Calculate common epidemiologic parameters (person-time, exposure, incidence, prevalence, etc.) with strategic guidance from the Epidemiology Strategists and Scientists As directed by the Strategists and Scientists, create code lists for use with selected data sources (e.g., billing codes) and for use in specific analyses As directed by the Strategists and Scientists, create tables, figures and graphs summarizing pertinent data and in a format potentially usable for additional analyses (e.g., meta-analysis) Create displays of data for oral presentation (i.e., power point) and written documents, including regulatory submissions Conducts QC of all literature reviews and other epidemiology content to ensure accuracy Upload all working and final documents and maintains the complete meta-data for each review into the Epidemiology Literature Review and Category C Studies Archives (among other SharePoint pages) on the WWPS/Epidemiology SP site for future reference and re-use. Execute any other scientific, regulatory, compliance., tactical and/or operational tasks necessary for the successful creation and delivery of epidemiology studies and related content. Comply with internal and external processes and guidelines while managing the literature review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned literature review.     Qualification & Experience MS level degree or higher in a life or health science with training specific to public health, health services research, epidemiology, clinical research, biostatistics or similar. Applicants with a BA/BS in any of the disciplines listed above will also be considered if they have additional years of relevant hands-on experience (see below). Minimum of 2 years of documented pharmaceutical or academic experience in epidemiology, pharmacoepidemiology, health economics and outcomes research, health services research, other observational research, secondary data analysis, biostatistics or public health