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    

Responsibilities In consultation with GRM TA Lead or designee, support the implementation and management of RMPs and related aRMMs/APVAs, as required Support the management of RMP and related aRMMs/APVAs (e.g. global, regional and/or local commitments) implementation and associated LM and REMS collaborations, including but not limited to Complex aRMMs (i.e., Pregnancy Prevention Programs, Controlled Distribution Programs, etc.). aRMM direct import (DI) activities (i.e., coordinate and monitor DI vendor website and associated alerts). Business agreement changes (in-licensing/Pharmacovigilance Agreements) that impact RM. Additional RM related activities include but not limited to GRM related training management (i.e. planning/tracking/repository) in collaboration with PV Learning Strategy function. aRMM effectiveness related activities (i.e., manage data acquisition, etc.). Ongoing GRM TA Regulatory Information Management system (Verity) related tasks for RMPs and aRMMs, including process improvements (i.e., Verity User Guide/User Requirements and associated work instructions). Track budget spend and monitor vendor key performance indicators, as needed. Maintenance, tracking and support repository of all materials and queries related to above.     Qualification & Experience Advanced scientific degree preferred More than 3 years of relevant pharmaceutical industry experience Experience in global pharmaceutical safety risk management is preferred Understanding of pharmacovigilance/regulatory environment is expected  

Responsibilities Design and manage the development of modular, reusable, elegantly designed and maintainable software or solutions that supports the RA organization as well as other Cross Functional strategic initiatives. Participate fit-gap workshops with business providing effort estimates and solutions proposals. Hands on, solution driven, and customer focused. Develop and maintain the code repositories for which you are responsible and respond rapidly to bug reports or security vulnerability issues. Embody and integrate software development best practices into your everyday work and inspire others within the engineering community to emulate these practices. Collaborate extensively with your colleagues across Security, Compliance, Engineering, Project Management, Product Management, Product Service Management and Business Management. Continue support for moving Publishing other RA platforms to the cloud. Ensure delivered solutions adhere to architectural and development standards, best practices, and meet requirements as recommended in the architecture handbook. Ensure designed solutions are aligned with Data and Analytics strategy standards and roadmap. Bring innovations to the solutions and add measurable values to RA Business.     Qualification & Experience University degree in Information Technology, Computer Sciences, Life Sciences or similar.. 10+ years of experience in IT technology development experience, preferably with 5+ years of experience working with Pharma Regulatory affairs (RA) business. Experience working in with RA Publishing business is a plus.  

Responsibilities Manages all applicable finance activities, including Request for Proposal (RFP) for bidding & vendor selection, Grants, Purchase Orders (PO), invoice approval and tracking financial metrics. Provides guidance to the CTSM for packaging design optimization. Advises GCS Study Team on packaging designs to ensure optimal usage of available capacity and budget. Manages Order Alignment with GCS Study team members to coordinate packaging order preparation and to ensure proactive resolution of any packaging order related question. Acts as the key business partner for operational interactions with the Vendors. Reviews the vendor capacity, resource planning and distribution tracker and verifies this with the study requirements to ensure the study timelines and specifications are met. Coordinates material routing and inventory management of all drug product, primary packed materials, packaging components and labels for packaging orders at external vendors. Liaises with CTSM/SCM on a regular basis to create packaging orders based on the project specific requirements. Interacts with the SCM and CTSM to flag potential issues or bottlenecks due to availability of PP/DP or locally/ regionally sources items at the respective local hub. Ensures most cost-efficient material flow, minimizing waste and allowing the flexibility to accommodate the changing demand. Manages all packaging activities executed by vendors and ensures agreed milestones and cost are met and creates packaging orders in SAP. Coordinates logistic documents for facilitating import requirements. Manages deviations occurring at external vendors and escalates high level issues/bottlenecks to the relevant internal GCS stakeholders and external partners. Participates or supports external inspections and audits together with TRD QA (and GCP QA where applicable) to assess packaging contractor capabilities.     Qualification & Experience 2+ years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise Apprenticeship or formal education in a logistical, technical, or related business area  

Responsibilities Acquire new business within assigned district(s), where there is no existing Diagnostics and / or AlinIQ footprint by consultative strategic team selling to achieve deep understanding of unmet needs and pain points of customers and stakeholders Set and achieve or exceed quarterly, annual sales quotas and manage sales budgets Focus on C-Suite value driver discussions including population/community health, merger and acquisitions, remote patient monitoring, risk stratification of business and patients Identify new opportunities for growth by focusing on end-to-end health care improvements as primary value driver for in and outside the lab to pull through digital health solution sales and reagent sales Be knowledgeable about industry trends, changing market regulations and healthcare policy within defined customer segment. Understand the impact on customers and their key care-abouts. Lead and execute complex contract negotiations to achieve the sales quota for given customer base. Create strong territory and strategic account plans to lay out strategic approach and share best practices with larger Sales team to help drive a culture of excellence. Review account activity, anticipate customer needs and improve customer satisfaction. Accountable for driving market share growth through new business opportunity realization. The role is instrumental in expanding brand reputation and delivery of sales and profitability objectives. Research target accounts to understand performance KPIs and customer strategies to drive conversations that demonstrate how the application of IT enablers and service solutions in/outside of the lab and across the broader healthcare space can improve performance KPIs and strategies. Work collaboratively with sales and DHS counterparts to achieve performance targets and exceed customer expectations. Navigate within a highly matrixed environment using strong communication and interpersonal skills to coordinate appropriate Abbott resources and support necessary Ensures that all activities are performed in compliance with quality system requirements.     Qualification & Experience Bachelor’s degree is required; master’s degree preferred. Bachelor’s degree in medical, life sciences, IT or medical technology is preferred Abbott Core Dx Digital Health Solutions Fluent in English and in the Local language Experience leading & executing simple to complex (multi stakeholder/multiyear) contract negotiations. 2-4 years in sales roles  

Responsibilities Manages and provides leadership to an efficient and effective regulatory affairs team. Assists in the career growth of Associates and Senior Associates. Plans and manages regulatory submissions and activities for products throughout the life-cycle of a product in compliance with Health Canada regulatory requirements and ICH guidelines. Reviews submissions, including deficiency letters, to ensure timeliness, accuracy, consistency, completeness, and compliance with regulatory standards. Ensures that technical data and regulatory summaries are presented clearly and succinctly to optimize the regulatory authority review and approval process. Provides support to junior staff in the creation of submission documents and coach as necessary to ensure continuing development of regulatory skills. Ensures regulatory maintenance of approved drug products. Helps regulatory staff overcome difficulties in the completion of projects by diplomatically managing relationships with business partners, regulatory agencies and internal staff. Provides strategic guidance and advice. Contributes to the creation of submission strategies throughout the product life cycle. Shows good judgment to determine when to escalate problems to the Director of Regulatory Affairs. Tracks critical attributes of projects to ensure accountability and efficiency. Creates or supports the generation of reports as required. Supports the Director in developing and implementing departmental goals to coincide with corporate goals. Contributes to the creation and implementation of standards and best practices within the department to improve efficiency and quality of processes. Reviews internal documentation (labeling, master batch records, specifications) and external documentation (clinical reports) for adherence to regulatory guidelines. Builds and maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters. Builds and maintains a good working relationship with regulatory agencies. Uses the relationship to understand expectations beyond that which is presented in guidelines and policy statements. Maintains current awareness of regulatory guidelines (Health Canada, ICH, FDA, etc.). Provides sound regulatory input and support to product development and technical transfer projects. Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development, QA, Marketing, and other functions as required. Provides cross-functional review/input from a regulatory, scientific and technical viewpoint. Maintains and applies knowledge of product data, marketing objectives, and quality procedures. May perform other regulatory affairs functions and activities as required to achieve departmental or operational priorities and prioritizes other responsibilities to meet additional work requirements.     Qualification & Experience University degree in Science, Pharmacy, Life Sciences with post-graduate certification in Regulatory Affairs program. No less than 8 years of relevant industry experience No less than 3 years of relevant Health Canada and sterile injectable experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"    

Responsibilities Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality Process: 1) Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables.     Qualification & Experience Experience: >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications) Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD)