Responsibilities Apply clinical judgement, critical thinking, and regulatory knowledge to the management of adverse event data within GPS systems to ensure data integrity, consistency, and compliance. Continuously expand knowledge of Lilly compounds / products (e.g., design of clinical trials, safety profile, regulatory commitments, indications, identified risks, main adverse reactions, risk minimization activities). Continuously expand regulatory expertise on case collection and expedited reporting requirements dictated by major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA). Participates as a cross functional team member of study teams, as assigned Understand functioning of systems owned GPS (e.g., MOSAIC, LSS), contributing with updates / enhancements and solution of workflow issues Process adverse events and other safety information from various sources (e.g., Clinical Trials, Patient Support Programs, Lilly Market Research, literature, spontaneous reports, etc.). Assess individual reports identifying gaps of information and the need to conduct follow-up to clarify seriousness, expectedness, causality and achieve case completion. Comply with internal and external timelines for managing adverse event data entry. Lead/support literature search strategy updates and system issues/enhancements. Translate global / regional / local PhV regulatory requirements into expedited reporting rules and conduct Product License studies activities. Responsible for the completeness and accuracy of data management within the GPS Systems, and other associated case management activities. These activities may include but are not limited to: Management of adverse events arising from various sources including but not limited to literature, Patient Support Programs (PSPs), Clinical Trials (CT), spontaneous, pregnancy, devices, Lilly Market Research (LMR), etc. Ensure the following: appropriate serious outcome criteria for adverse events are selected, appropriate terms selected from source documents, listedness and relatedness is completed accurately, and cases are available as appropriate for Medical Review. Complete or verify MedDRA coding. Identify concomitant medication and relevant medical history. Ensure appropriate Follow Up is obtained utilizing a customer experience mindset whether working with patients, HCPs, or investigators/site personnel. Understand and proactively manage incoming work by prioritizing and collaborating with global colleagues. Prioritize work to ensure internal and regulatory timelines are met. Be a pro-active member providing expertise on local or global projects to ensure Safety Management is consistently delivering innovation and improvements. Maintain understanding of PV agreements for assigned products.     Qualification & Experience Master’s degree or equivalent experience. Healthcare degree, or study in the area of pharmaceutical/biological science preferred. Critical thinking to solve problems, and make decisions autonomously, and as part of a team. Ability to apply critical thinking and flexibility in the use of electronic systems and adapting new and changing systems.  

Responsibilities Planning, designing, developing, uploading, editing, and managing periodic reviews of the MA tactics listed above Tracking and monitoring the overall quality of the deliverable and timelines to ensure affiliate teams have adequate time for localization Serve as a first point of contact regarding material submission, tracking, follow-up, and platform support Check for submission accuracy and completeness and tactics Ensure tasks are assigned to appropriate reviewers to complete new and periodic reviews Verifying that all functional inputs are secured Ensuring all the supporting documents are uploaded to the content review and approval platform (VVMC) prior to submitting the tactic for Medical/Legal/Regulatory review by global and/or affiliate teams Shepherding projects through their lifecycle, from kick-off through withdrawal Demonstrate knowledge of tactic types and the associated business rules Demonstrate a thorough understating of Lilly's review processes and must be capable of understanding and applying these processes and requirements when executing their role Comprehending project/content management tools such as Wrike, Veeva Vault, and any other tools that may be rolled out from time-to-time to meet the business requirements Identifying ways to continuously improve processes by exploring opportunities to reduce costs and by documenting the rationale behind tactic decisions Ensuring quality, speed, value, and compliance throughout the tactic lifecycle Participating actively in deviation investigations and contribute to continuous improvement efforts as role dictates Managing and tracking timelines for tactics and key milestones Anticipating potential issues, proactively communicating with stakeholders and reviewers, and working toward resolutions in a timely and compliant manner Manage print/digital tactic fulfilment process   Qualification & Experience Bachelor’s degree with relevant work experience. MBA in Pharma/ IT/ Marketing from a reputed B-School or Master in Pharma/ Biotechnology/Life Science Domain is preferred. 3 Years of experience in digital content project management/coordination (eg, Emailers, Web sites, and Banners etc.) space in Pharma /Marketing/Digital Marketing/ Vendor Management experience is preferable Strong written and verbal communication skills in English  

Responsibilities Helps create best-in-class internal communications function across the R&D organization that fuels employee engagement, influences connectivity and culture, positively impacting all functions. Develops communication materials using a variety of tactics (written communications, presentation materials, MS-Teams and other platforms, town halls, small group meetings, etc.) to articulate key messages. Ensures communication messaging and materials are high quality, accurate, appropriate and integrated with Elanco’s priorities and themes. Develop and maintain strong relationships with key stakeholders, including executives, internal teams, external partners, and global communications team. Assists senior leaders in writing and editing impactful and engaging content that effectively describes and promotes employee engagement and supports other programs and initiatives at Elanco. Analyze and interpret data related to employee communication and engagement (such as VOE) to inform decision-making. Build dashboards for R&D initiatives such as portfolio or enterprise level information rollouts to the organization. Leads through shared learning, process improvement, and identification of special/complex continuous improvement projects. Works with appropriate firm personnel to create and maintain content for employee communication channels, and partners with the broader marketing and IT teams to explores/recommends new channels or technologies where possible. Manages content for the global company intranet, ensuring that it is up-to-date, engaging, and informative. Manage communication budgets and implement metrics reports to measure effectiveness of internal communication channels and measures internal communications with the goal of continuously improving internal communications strategy to reach and engage employees.     Qualification & Experience Minimum 8 years of internal communications experience in pharma/medical device/life sciences domain. A strong collaborator with solid English language writing, editing and proofreading skills, with the ability to develop clear and concise messaging for different audiences. Experience managing communication initiatives across multiple channels and touchpoints. Demonstrates strong learning agility to adapt to R&D environment and processes. Strong skills in working with and learning different IT platforms (power point, Power BI, PMO software, etc)  

Responsibilities Provide statistical input to the design, analysis, reporting and interpretation of clinical studies and contribution to publications. Use SAS or other software to develop custom programming code to generate tables, data listings, graphs and derived datasets as specified in the protocol/statistical analysis plan. Ensure that outputs meet quality standards and project requirements. Perform validation programming and work with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keep project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs and relevant regulatory guidelines. Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload. Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others. Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Negotiate and establish accurate time estimates for completion of study activities with internal team members and statistical management, and complete project activities within timeframe allotted. Assist in drafting regulatory submissions. Effectively utilize current technologies and available tools for conducting the analyses. Keeping up-to-date with current literature and research new methodologies. Identifying, developing and implementing novel statistical methodologies in support of medicine development Ensure scientific integrity and animal welfare in all activities. Interact with global statisticians and implement recommendations locally. Create and maintain standard macros and applications to improve the efficiency of the department. Proactively participate in and/or lead process/quality improvement initiatives, standardization, and other non-clinical initiatives. Contribute to the mentoring of other team members, developing training courses, presenting training materials, providing feedback, or guiding new associates in process. Engage in knowledge share activities.

Responsibilities Responsible for contribution to or participation in trial planning activities related to medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialist to enable decision making. Responsible for documenting medical review in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager , Trial Manager(s) and Medical Specialist during trial conduct. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review.   Qualification & Experience Minimum as Graduate in Medicine or other relevant (MBBS & MD in pharmacology preferred, MBBS & MD in other clinical/paraclinical areas with relevant experience in clinical patient management/ clinical research). 2 + years of experience as Medical Reviewer is preferred. Good knowledge of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), GCP (Good clinical Practice). Demonstrated computer skills (MS Office, MS Project, PowerPoint). Excellent understanding of medical terminology and clinical trial activities. Excellent written and spoken English.    

Qualification & Experience Candidate must have experience in regulatory medical writing. Experience in authoring protocols, clinical study reports, investigator’s brochures, informed consent forms, summary documents, etc. Experience in multiple therapeutic areas, including but not limited to vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology oncology, etc. Strong communication and interpersonal skills. Bachelors/advanced degree or equivalent education/degree in life sciences/healthcare. Experience from the pharmaceutical /CRO industry. Ability to work independently and lead projects. Strong analytical skills. Commitment to highest quality outputs, including high attention to detail. Ability to manage variable workload.  

Qualification & Experience Degree/MBA/MSW - HR Experience: 10+ years(Hospital Exp)   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

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 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.