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Johnson & Johnson Remote jobs - 121 jobs

  • Strategic Director, MedTech Commercial Ops - Remote

    Johnson & Johnson 4.7company rating

    Santa Clara, CA jobs

    A leading healthcare innovator is seeking a Director of Commercial Operations for their MedTech division in Santa Clara, CA. You will drive global business results for the Polyphonic digital ecosystem by shaping go-to-market strategies and enhancing sales enablement. The ideal candidate has over 10 years of experience in commercial operations within healthcare, strategic acumen, and knowledge of MedTech processes. This role may require domestic and international travel and offers a salary range of $146,000 to $251,850. #J-18808-Ljbffr
    $146k-251.9k yearly 5d ago
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  • Senior Product Manager, Peripheral Portfolio Strategy (Remote)

    Johnson & Johnson 4.7company rating

    Santa Clara, CA jobs

    A global healthcare leader is seeking a Sr. Product Manager for their Peripheral Portfolio Strategy team. This fully remote role requires strong experience in medical devices and collaboration with various internal teams. The ideal candidate will help develop innovative product strategies and engage with key clinical stakeholders to identify market opportunities, driving accountability and success within the company. An MBA is preferred, and candidates must be comfortable with frequent travel. #J-18808-Ljbffr
    $125k-162k yearly est. 5d ago
  • Remote Global Regulatory Lead - TA Liaisons

    Gilead Sciences, Inc. 4.5company rating

    Washington, DC jobs

    A leading biopharmaceutical company is seeking an Associate Director to serve as Regional Regulatory Lead, overseeing complex regulatory submissions and managing cross-functional teams. The ideal candidate should have significant regulatory experience, a strong track record in strategy development, and excellent negotiation skills. This role offers a chance to influence drug development processes in a dynamic environment. #J-18808-Ljbffr
    $136k-195k yearly est. 4d ago
  • Sr. Operations Associate

    Eli Lilly and Company 4.6company rating

    Parkton, NC jobs

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Sr. Operations Associate (OA) will report to an Associate Director of Packaging Operations. The OA will be responsible for providing leadership within the area's process team, managing projects and process improvements, acting, as a liaison between operations and multiple functional groups to support event management, change controls, etc. The OA will also assist the operations team in the day to day management of the production floor and lead investigations and drive implementation of actions associated with deviations. Key Objectives/Deliverables: Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes and controls for the Packaging area. Monitor and build a strong safety culture Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations. Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE). Understand and influence the manufacturing control strategy for their area. Trained as a Lead Investigator Development and monitoring of metrics for the area Aid in issue resolution, batch/product approvals, and production schedule execution. Lead specific activities of the process teams. Potential back-up of Associate Director/Manager Minimum Requirements: Bachelor's degree (or equivalent work experience) Experience: 2 to 5 years Operations or Manufacturing Support in Pharmaceuticals Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Goals Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA. Excellent interpersonal, written and oral communication skills Ability to travel up to 10% Additional Preferences: Technical or Science degree preferred Previous leadership/supervisory experience helpful Career interests in Operations Leadership Device Assembly or Packaging experience Education Requirements: Bachelors degree (or equivalent work experience in cGMP production) Other Information: The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities. Must be flexible to attend meetings or support off-shifts (operations is 24/7) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $160,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $65.3k-160.6k yearly Auto-Apply 4d ago
  • Director, HEOR - Oncology

    Eli Lilly and Company 4.6company rating

    Remote

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: The Oncology Medical Affairs team has an immediate opening for a Health Economics and Outcomes Research (HEOR) Scientist. The demand for high-quality economic and outcomes research (HEOR) and real-world evidence (RWE) to support drug development, health technology assessment/access decisions, product differentiation, and clinical decision-making continues to grow. Because of this heightened need, this team is seeking a talented individual who is energetic, creative, diverse, influential, and collaborative, to join the HEOR Oncology function and Team Lilly. This HEOR scientist will be expected to provide strategic insight and leadership into the health outcomes (HO) evidence needs (e.g., health economics, access and reimbursement) for the Lilly Oncology portfolio, among other pipeline projects per the business' needs. This scientist's duties may range from developing and articulating product-value propositions, patient-reported outcomes strategies, real-world evidence generation, and differentiation strategies using HO research, depending on the individual assignment. This researcher will leverage their knowledge of health outcomes disciplines, therapeutic-area knowledge of disease states in the Lilly portfolio, comprehension of drug development and commercialization, and geographic market learning in this role. Research project ownership and execution is required. Responsibilities: Strategy Drives sustained integration of HEOR from early-clinical development through commercialization Develops and oversees HO research strategy for Lilly Oncology portfolio compounds. Serves as a strategic partner on lead/core teams throughout development and/or commercialization lifecycles Formulates and drives Patient-Focused Outcome, Real-World Evidence, and/or economic-value strategies for priority products and geographies. Study Development and Execution Executes bold high-impact science for products across the lifecycle, to influence and support evidence needs for Lilly products in support of improving patient outcomes. Applies technical expertise (e.g., scope or depth in statistical analysis, economic modeling, clinical trials, PFO development, observational/epidemiologic research, and health technology or other value assessment) to execute HEOR. Applies disease-state knowledge and research methods to solve HO issues associated with registration, pricing, reimbursement, and access initiatives. Organizational Leadership and Influence Communicates technical expertise with business acumen in a simple, succinct way. Leads HO evidence planning and implementation in collaboration with cross-functional teams across the development and commercialization lifecycle. Integrates and influences key business partners around HEOR prioritization, trade-offs, and recommendations to achieve strategic goals. Provides consultation, input, and strategic direction about how to leverage HEOR to the enterprise Triages business partners' requests with excellent prioritization and timeliness. Information Dissemination Communicates HO information to internal business partners, the scientific community, and customers, adapted for the audience and in a timely manner. Leads research dissemination strategies and communication efforts including abstracts, posters, podium presentations, promotional materials, and manuscripts. Plans for, aligns, and drives application of results/deliverables to increase the impact of HO work Environmental Awareness Maintains awareness of significant developments in disease states in the Lilly portfolio and HO field including current HO methodologies, HO applications, and other issues as appropriate for the position. Anticipates and evaluates future market needs and trends for HO information within pertinent therapeutic area and geography of interest. Monitors and influences internal and external environmental factors that shape and impact generation and use of HO research. Project Management Ensures HO projects meet timelines, budget, and scope by coordinating research efforts with cross-functional Lilly business partners and external collaborators as appropriate. Basic Requirements: Doctorate (PhD, MD), PharmD/MS degree with 10+ years' experience in creating, executing, and delivering outcomes strategies/projects, with at least 5 years' experience in therapeutic area expertise (preference to Oncology) Additional Preferences: Strong comprehension and excellent written and verbal communication skills. Demonstrated ability to translate and disseminate complex scientific information in a clear and concise manner Demonstrated ability to influence and collaborate within and across teams Proven ability to be flexible with work assignments, deliver results with quality and speed, especially in an Oncology dynamic environment Understanding of health care systems in at least one of US, Europe, and/or Asia Understanding of and experience with health care delivery models and clinical research Technical and analytic capabilities in one or more of the following areas: economic modeling, economic evaluation, cost-efficacy evaluation, patient-focused outcomes, real-world evidence, burden of disease, epidemiology, statistics, health care policy Demonstrated ability to drive research agendas to completion and dissemination Ability to think and act globally with a customer focus and a solution orientation Additional Information: Domestic and international travel may be necessary (approximately 25%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $165,000 - $316,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $165k-316.8k yearly Auto-Apply 5d ago
  • National Key Account Executive- Eye Care (Retina)

    Abbvie 4.7company rating

    Irvine, CA jobs

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description This position offers remote work flexibility, allowing candidates to work from any location within the United States. The Key Account Executive - Eye Care (Retina) is an in-field position focused on our top retina customers including independent retina group practices and private-equity backed groups. The Key Account Executive is responsible for developing relationships with C-Suite and functional leaders within our top accounts and collaborating with the accounts to develop customized business plans and strategies to promote AbbVie products. Key Account Executive - Eye Care (Retina) is also responsible for execution of the contracting strategies for retina products and collaboration with GPOs and alignment with Market Access and Contracting Operations. Primary responsibilities include developing strong relationships at various levels with key account personnel, collaborating with account leadership to identify opportunities for growth, working with various sales and marketing groups to facilitate account-specific program development and best-in-class execution by leading both account and AbbVie pull-through activities. Responsibilities: Develop relationships at C-Suite and key functional leaders for Key Accounts Work with Key Accounts, affiliated GPOs, US Market Access, and retina brand team to develop customized business plans and strategies to promote AbbVie products Act as thought leaders for Key Accounts, and as the “voice of the customer” back to retina sales and marketing , and AbbVie eyecare leadership teams Collaborate with internal marketing teams to develop tools and materials for best-in-class program execution Work cross functionally with US Market Access, Contracting Operations, and external GPO teams to monitor and pull through contracting strategies for retina products Identify areas of opportunity within accounts to train and educate doctors, staff, and key leaders on AbbVie's products and disease states Find efficient ways to communicate the vast groups of non-called-on doctors within the top accounts Provide subject matter expertise to the field sales organization Actively participates in leadership team meetings when appropriate and attends major industry/customer conferences, and other applicable meetings. Driving a personal auto or company car or truck, or a powered piece of material handling equipment Qualifications Bachelor's degree in health, sciences, pharmacy or business-related field preferred or relevant and equivalent industry experience required. A minimum of 7 years of professional industry experience with an established track record of managing industry-based marketing functions - preferably with an in-depth knowledge of pharmaceutical and medical device industry marketing, sales and business development .Minimum five years of successful sales management or equivalent people leadership experience Strong interpersonal, relationship building, and presentation skills are needed to effectively work with diverse customers and employees across a variety of organizational levels and disciplines, including senior executives, therapeutic decision makers, and other influencers. Well-developed verbal and written communication skills, including clear presentation of technical and analytical information to various management levels and external parties. Proven leadership ability and ability to influence through others. High standards for professional conduct with the ability to prioritize, execute multiple critical issues concurrently, make difficult decisions, deal quickly and effectively with change, and constructively confront and resolve conflict. Track record of meeting or exceeding commercial targets and working effectively in complex environments Superior organization, project management marketing planning and strategic development skills, strong analytical, and financial/budgetary experience and the ability to execute key strategies Ability to travel as needed for work requirements - travel is expected to be 50% An essential requirement of your position is to satisfy all applicable health care industry representative (HCIR) credentialing requirements to gain and maintain entry into facilities and organizations that are in your assigned territory. You must also be in good standing and/or eligible to obtain these credentials. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, proof of immunization/vaccination for various diseases, fingerprinting and specific licenses required by individual state or cities. Please remember that you are solely responsible for ensuring that you satisfy all HCIR credentialing requirements and for any associated liability for failing to do so. to AbbVie has resources to answer questions you may have regarding your responsibilities. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $109k-142k yearly est. 1d ago
  • Clinical Pharmacologist/Clinical Research Physician

    Eli Lilly and Company 4.6company rating

    Remote

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Purpose and Role Lilly is seeking an individual with expertise in early clinical development, including clinical pharmacology, to join a passionate team with a robust, industry-leading pipeline. The ideal candidate will have expertise in diabetes, obesity, cardiovascular, renal or endocrinology drug development with demonstrated learning agility, a problem-solving mindset, and the willingness to develop knowledge and skills in new areas. The Clinical Research Physician (CRP) will be the clinician to progress multiple early clinical assets into first-in-human studies or support their further development through the conduct of clinical pharmacology and mechanistic studies. Through the application of scientific and medical training, the CRP participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contracts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders. The CRP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. In addition, the CRP works with the basic research scientists to plan pre-clinical studies, develop biomarker plans, and serves as a scientific and medical resource for study teams, departments, and others as needed. Basic Qualifications Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.). Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer. Additional Skills/Preferences At least two (2) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of Phase 1 and Phase 2 studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management). Pharmaceutical company experience preferable. Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable. Experience in Clinical Pharmacology preferable. Additional scientific training or degree (M.S., Ph.D.) preferable. Fluent in English; both written and verbal communications. Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills. Demonstrated ability to influence others (both within teams and a matrix environment) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (approximately 10-15%). Core Job Responsibilities The primary responsibilities of the CRP are generally related to early phase clinical studies and late phase biopharmaceutical submission studies. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission. Support preparation for first-in-human dosing studies including biomarker plans. Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharmaceutical plan to support submission. Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies. Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug disease response models. Contribute, as an integral member of the Exploratory Medicine and Pharmacology team, to global Phase 1 and 2 clinical studies as well as submission planning activities. Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development. Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharmaceutical submission plan. Clinical Research/Trial Execution and Support Design and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic studies). Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations. Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research. Design and oversee implementation methods for development and biomarker qualification studies. Design, create, and provide oversight for protocol development. Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements. Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements. Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group. Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects. Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Serve as resource to clinical trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures. Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety. Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers. Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process. Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies. Publish results of research projects as appropriate. Consider, review, or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials. Provide clinical reports for local and international regulatory purposes. Regulatory Support Activities Support and assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response. People Management and Development: Develop and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience. Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness. Develop an organizational talent base that demonstrates judgment-based risk taking and decision making. Business customer support (pre and post launch support) Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, New Product Planning, and business development. Understand the scientific information needs of all Development customers (business unit, payers, patients, health care providers). Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. Support business-to-business and business-to-government activities as medical expert. Contribute actively on an ongoing basis to the strategic planning for the brand. Become familiar with market archetypes and potential influence on the medical interventions for the product. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $389,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $112k-141k yearly est. Auto-Apply 10d ago
  • Automation Engineer

    Eli Lilly and Company 4.6company rating

    Lebanon, TN jobs

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is currently constructing an advanced manufacturing facility for production of advanced therapy medicinal products (ATMPs) located in Lebanon, IN. This facility is intended to provide current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Responsibilities: As an Automation Engineer you will provide automation design and oversight to the delivery of Lilly's new Lebanon LP2 facility. Collaborate with system integrators to deliver all aspects of Automation. Support key corporate initiatives such as life cycle management, Engineering information management, and cyber security. Drive automation governance and replication Tier 1 equipment, architecture, and Automation/IT systems and solutions. * Safety - Work safely and continually looks for improvements in personnel and equipment safety, ensure safe design and operation of new equipment, ensure automation design reflects safety concerns for operations and maintenance. Automation Design * Design and implement Automation Strategies that allow the operators to interact and manipulate the process in compliance with cGMP batch manufacturing requirements. * Generate/Update Design SDLC documentation. Automation/Control Discipline * Partner with colleagues to properly support and enhance the Automated Systems and Equipment including the adjustments on PID Control Parameters. * Perform solution assessment and performance reviews and verified the proper and efficient operation of the automated systems. * Partner with colleagues to support the discipline through solution assessment, replication, and development. * Manage tools, and implement engineering standards, master specifications and best practices. * Provide technical coaching and consultation to other Lilly engineers and facilitate shared learning forums. * Support Projects and the integration of new equipment/technologies to the manufacturing workflow. * Support Automated System Commissioning and Qualifications. * Technology and Innovation. Keep current on external trends and practices to evaluate technology for application within Lilly. Basic Qualifications: * Bachelor's Degree in Engineering or related field. * 5+ years of experience in automation or process control. Additional Skills and Preferences related to the roles we are recruiting: * Experience with Emerson DeltaV Systems, Rockwell Automation, OSI/PI Historian, or related automation and control platform. * Expertise in Rockwell Automation Platforms including FactoryTalk View SCADA and ControlLogix PLC's. * Knowledge of Drug Product manufacturing processes including formulation, equipment preparation, and filling. * Knowledge of Drug Substance manufacturing processes including large and/small molecule and Batch. * Knowledge of plant utility systems including purified water, clean steam, process air, and recovery and environmental systems. * Knowledge of building management systems (HVAC) and qualified building management systems for critical monitoring. * Knowledge related to ISE S95 principles and IT/Automation integration. * Experience in a pharmaceutical or GMP industry. * Experience in OSI/PI Data Historians or related technology. * Experience in Microsoft operating systems, virtual environments, and networking. * Communicate effectively with internal customers, business partners, and leadership including written and visual presentations. * Experience in Automation Project Delivery related to Major Capital delivery. * Technical leadership on automation project delivery Additional Information: * This is an onsite position that requires onsite presence the majority of the time, with some flexibility for working from home depending on business need. * This position is based in Lebanon, IN and is not a fully remote role. This would require relocation to Lebanon, IN area (within commuting distance). * Some business travel will be required for this role including OUS. Business travel typically includes design review meetings at A&E firms and equipment OEM's, Factory Acceptance Testing, and training. Travel is not expected to exceed 10-20%. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $66k-171.6k yearly Auto-Apply 45d ago
  • Remote District Business Manager, Oncology/Hematology

    Bristol Myers Squibb 4.6company rating

    San Francisco, CA jobs

    A leading biopharmaceutical company is seeking a District Business Manager to lead their Oncology/Hematology Sales team in San Francisco. This role involves motivating a team, analyzing market data, and developing business plans to enhance performance. The ideal candidate will have a strong background in sales management and a degree in a related field. Join us to make a tangible difference in the lives of cancer patients while building a rewarding career. #J-18808-Ljbffr
    $112k-149k yearly est. 5d ago
  • Design + Human Factors Engineering Senior Director

    Eli Lilly and Company 4.6company rating

    Remote

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Title: Design + Human Factors Engineering Senior Director -DDCS Department Name: Delivery, Device and Connected Solutions Purpose: In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years. In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company. This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries. Position responsibilities: Design and Human Factors: Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio. Ensures that: Human capabilities and limitations are adequately reflected in the system requirements Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs) Human performance and safety risks are appropriately addressed in planning. The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance. Human Factors Standards are appropriately documented in the Design Control Quality System. Project milestones are met by identifying and managing risks and escalating as appropriate. Functional budgets and project forecasts are maintained in compliance with P&L People: Responsible for developing and managing the Design + Human Factors Engineering team. Provides leadership, feedback, coaching, performance and career development support to direct reports. Ensures career development discussions, talent assessment, and succession planning are in place for employees. Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization. Strategy / Corporate Integration: Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team. The delivery strategy and project workload are closely linked to that of the Business Units, Sales Affiliates, Medical, Manufacturing and Marketing. The position would work closely with the above groups to consistently align the strategies and projects. Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry Relationship Management: Ensure compliance with external collaborations Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units) Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve Minimum requirements: MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience. Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products. Experience working within a Sponsor organization Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting. Human subjects research bioethics and study design Prior supervisory experience of team organization Ability to work effectively across boundaries Demonstrated quality mindset, ability to influence and leadership capabilities Additional Skills and Preferences: Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75) Business skills (capital and expense differentiation and impact on COGS and variance). Communication and interpersonal skills necessary for broad interactions at all levels of the corporation. Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.). Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners. Leadership skills with previous experience managing technical personnel and alliance partnerships Demonstrated ability to lead cross-functional teams Additional Information Position Location: Indianapolis, IN Ability to travel ~10-20% of the time, both domestic and international Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $163,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $163.5k-264k yearly Auto-Apply 49d ago
  • Field Clinical Specialist - Shockwave -Dallas, TX - Remote

    Johnson & Johnson 4.7company rating

    Dallas, TX jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: MedTech Sales Job Sub Function: Clinical Sales - Hospital/Hospital Systems (Commission) Job Category: Professional All Job Posting Locations: Dallas, Texas, United States : Job Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Field Clinical Specialist is a visible position that will provide case support to physicians within certain territories. Case support will be done on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) technology. The Field Clinical Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. Case support may be required to support other territories at certain times. You must be located in the Dallas area. Essential Job Functions * Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. * Effectively meet the needs of internal and external customers with a sense of urgency and drive. * Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms. * Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders. * Partner with other clinical research colleagues to meet business needs in the field including site re-training, data collection for timely database locks and resolution of critical issues. * Administrative activities including training to procedures, manage territory travel and budgets. * Other duties as assigned. Qualifications * Minimum Bachelor's Degree in business, science, nursing or related fields, or equivalent experience. * Minimum 2 years' experience directly supporting interventional or surgical procedures within a hospital setting OR, 1 year of industry, hospital-based life sciences, sales support experience. Cardiovascular industry experience preferred but not required. * Working knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. * A history of effective collaboration with regulatory agencies through clinical studies and market releases. * Product knowledge including product vigilance and medical device reporting. * High attention to detail and accuracy. * Computer skills (MS Office products, word processing, spreadsheets, etc.). * Finance and budgeting knowledge. * Good prioritization and organizational skills. * Excellent critical thinking skills. * Excellent influencing and negotiation skills. * High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people. * Entrepreneurial "hands-on" experience. Pro-active and "can do" attitude. * Ability to consider and accept feedback and suggestions for continuous improvement. * Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such. * Effective written, verbal and presentation skills with all levels of customers and management. * Ability to work in a fast-paced environment while managing multiple priorities * Operate as a team and/or independently while demonstrating flexibility to changing requirements. * There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) * Significant travel >50% of time requiring the employee to be effective in a remote manner. * Employee may be required to lift objects up to 40lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space. Pay Transparency: Additional Information: * The base pay range for this position is $100,000 - plus a strong variable component. * The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. * This position is eligible for a car allowance through the Company's Fleet program * Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. * Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). * Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Behavior, Communication, Consulting, Cross-Selling, Customer Centricity, Customer Effort Score, Customer Retentions, Execution Focus, Goal Attainment, Hospital Operations, Innovation, Market Research, Medicines and Device Development and Regulation, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection
    $100k yearly Auto-Apply 11d ago
  • Sr Field Coordinator

    Johnson & Johnson 4.7company rating

    Danvers, MA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Sales Enablement Job Sub Function: Sales Operations & Administration Job Category: Business Enablement/Support All Job Posting Locations: Danvers, Massachusetts, United States of America, Remote (US) Job Description: About Cardiovascular Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This is a remote role available in all states/cities within United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. We are searching for the best talent for a Sr. Field Coordinator. You will be responsible for: Operational Efficiency & Process Improvement * Identifies operational gaps or barriers impacting field execution and develops practical, scalable solutions. * Analyzes workflows and processes to drive efficiency and reduce administrative friction for field teams. * Leads or supports improvement initiatives across Commercial Effectiveness, Sales Leadership, Marketing, Clinical, and other partners. Field Support & Issue Resolution * Highly professional and organized support for sales and clinical leadership to ensure new-hire onboarding and ongoing field operations operate at the needed speed and quality. * Serves as a central resource for resolving operational issues, system challenges, data inconsistencies, or process bottlenecks. * Monitors trends, flags risks, and proactively surfaces insights to improve planning and field operations. * Ensures tools, processes, and information are accurate, accessible, and aligned to commercial priorities. Cross-Functional Communication & Alignment * Collaborates with internal stakeholders to diagnose issues, clarify requirements, and align on solutions. * Communicates updates, guidance, and operational changes clearly and effectively to field teams. Data Integrity & Reporting * Ensures accurate data capture and reporting within CRM and other commercial systems. * Provides concise operational summaries and insights that highlight barriers, trends, and recommended actions. Team Support & Knowledge Transfer * Supports training and onboarding of coordinators and team members on operational processes and systems. * Shares best practices to strengthen consistency and effectiveness across the team. Leadership Behaviors * Demonstrates ownership, professionalism, and a field-first mindset while upholding Johnson & Johnson's Leadership Imperatives and Credo. Qualifications/Requirements * High school diploma required. Associate or bachelor's degree preferred. * Minimum of 4 years of administrative experience required. * Proficiency in Microsoft Office including Excel, PowerPoint, Word, SharePoint, and Outlook is required. * Experience with Ariba, Concur software preferred. * Strong written and verbal communication skills and the ability to work both as a team member and independently are required. * The ability to take initiative, be results oriented and manage multiple competing deliverables simultaneously is required. * Strong analytical and presentation skills are preferred. * This position is remote-based and may require up to 10% travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $55,000.00 - $88,550.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************
    $55k-88.6k yearly Auto-Apply 6d ago
  • Undergrad Intern - Amgen Foundation (Summer 2026)

    Amgen 4.8company rating

    Remote

    Career CategoryCollege JobJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Undergrad Intern - Amgen Foundation (Summer 2026) What You Will Do Let's do this. Let's change the world. During this program, you will gain real-world experience in the corporate social responsibility field and learn new skills around the management and operations of the Amgen Foundation. The Amgen Foundation is the main philanthropic arm of the biotechnology company Amgen, Inc. To help strengthen our staff engagement programs, analyze data to identify trends and potential areas for improvement in the Foundation's community giving programs. On completion, independently study and synthesize results, then share insights. Conduct independent research to learn about emerging staff engagement trends outside of our organization and share those back with the team. Recommend new ideas and approaches to engage employees in community giving. Shadow and support our team to learn about the Amgen Foundation's signature global programs; participate in short-term projects. Support the Foundation's management of its global communications strategy and operations. Support annual community grants cycle; participate in short-term projects, including analyzing and sharing insights around submitted grant applications. Provide support for the Foundation's day-to-day business operations that helps make the team's work smoother and more effective. What We Expect of You We are all different, yet we all use our unique contributions to serve patients. The curious individual we seek is a collaborative team member with these qualifications: Basic Qualifications: Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria: 18 years or older Currently enrolled in a full-time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent Completion of one year of study from an accredited college or university prior to the internship commencing Enrolled in a full-time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university Must not be employed at the time the internship starts Student must be located in the United States for the duration of the internship OR co-op Preferred Qualifications Degree concentration in Business Administration, Economics, Communications, Public Administration, Nonprofit Management, or Science Education Able to analyze and interpret data using a variety of reporting tools. Proficiency in conducting research and compiling comprehensive reports. Strong written and verbal communication skills. Able to effectively convey ideas through reporting and confidently present ideas and results to stakeholders of all levels. Able to produce reliably high-quality work with a keen attention to detail and adherence to consistently high standards. 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. The base pay range for this opportunity in the U.S. is [input market pay range]. Build a network of colleagues that will endure and grow throughout your time with us and beyond. Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. Participate in executive and social networking events, as well as community volunteer projects. Apply now and make a lasting impact with the Amgen team. careers.amgen.com Please search for Keyword R-229821 In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future full-time roles is not guaranteed. 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. . Salary Range -
    $41k-56k yearly est. Auto-Apply 60d+ ago
  • Sr. Field Clinical Engineer - Shockwave Medical

    Johnson & Johnson 4.7company rating

    Santa Clara, CA jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Operations Job Sub Function: Clinical/Medical Operations Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Senior Field Clinical Engineer - Shockwave Medical to join our team. This role is fully remote. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials. In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success. Essential Job Functions Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms. Provide clinical and technical support for key study investigators and clinical leaders at assigned sites. Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues. Administrative activities including training to procedures at site level. Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals. Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools. Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked. Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals. Partner with assigned physician advisors to create and deliver recruitment strategies. Partner with vendors that support recruitment activities. Other duties as assigned. Requirements · Bachelor's Degree in a scientific field of study or equivalent work experience. · Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital. · Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials. · Thorough knowledge of Good Clinical Practice (GCP) is required. · Ability to attain and maintain hospital credentials. · Ability to work in a fast-paced environment while managing multiple priorities. · Operate as a team and/or independently while demonstrating flexibility to changing requirements. · Experience with electronic data capture (EDC) systems. · Must have excellent verbal and written communication skills. · High attention to detail and accuracy. · Able to manage multiple project teams with guidance · Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.) · Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America. · May be required to lift up to 25 pounds. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : US $106,250 - $143,750 / Bay Area - $122,400 - $ 165,600 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $122.4k-165.6k yearly Auto-Apply 60d+ ago
  • Global Safety Medical Director - Hematology/Oncology

    Amgen 4.8company rating

    Remote

    Career CategorySafetyJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Global Safety Medical Director - Hematology/Oncology What you will do Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed. Validate safety signals and lead safety signal assessments Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.) Prepare/review core and regional risk management plans including additional risk minimization measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Prepare/review safety sections of new drug applications and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications: Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Experience in the study/research and/or treatment of Oncology disease states 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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. . Salary Range 243,245.00 USD - 319,267.00 USD
    $129k-182k yearly est. Auto-Apply 60d+ ago
  • Principal IS Business Analyst - Clinical Study Design and Analysis

    Amgen 4.8company rating

    Remote

    Career CategoryInformation SystemsJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Principal IS Business Analyst - Clinical Study Design and Analysis What you will do Let's do this. Let's change the world. Amgen is seeking a Principal IS Business Analyst to join the Clinical Study Design and Analysis (CSDA) product team. You will be responsible for "Run" and "Build" project portfolio execution, collaborate with business partners and other IS service leads to deliver IS capability and roadmap in support of business strategy and goals. The role 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 deliverables from the team. Roles & Responsibilities: Collaborates with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Captures the voice of the customer to define business processes and product needs. Works with Product Managers and customers to define scope and value for new developments. Collaborates with Engineering and Product Management to prioritize release scopes and refine the product backlog. Ensures non-functional requirements are included and prioritized in the product and release backlogs. Facilitates the breakdown of epics into features and sprint-sized user stories and participates in backlog reviews with the development team. Clearly expresses features in user stories and requirements so all team members and stakeholders understand how they fit into the product backlog. Translates complex business and technological needs into clear, actionable requirements for development teams. Ensures acceptance criteria and definition of done are well-defined. Works closely with UX to align technical requirements, scenarios, and business process maps with user experience designs. Stays focused on software development to ensure it meets requirements, providing proactive feedback to stakeholders. Develops and executes effective product demonstrations for internal and external stakeholders. Maintains accurate documentation of configurations, processes, and changes. Serves as a liaison between global DTI functional areas and global development scientists, prioritizing their needs and expectations. Manages a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree and 2 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Master's degree and 4 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor's degree and 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Associate's degree and 10 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR High school diploma / GED and 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery through technology. Experience with Agile software development methodologies (Scrum). Excellent communication skills and the ability to interface with senior leadership with confidence and clarity. Experience in writing requirements for the development of modern web applications. Experience in 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 and related technology needs. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code and no-code test automation software. Technical thought leadership. Ability to communicate technical or complex subject matters in business terms. Experience with Jira Align. Knowledge of cloud platforms (AWS, Azure/Databricks, GCP) and enterprise infrastructure technologies. Experience with DevOps, continuous integration, and continuous delivery methodologies. Professional Certifications: SAFe for Teams certification (preferred). Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members, with a demonstrated ability to delegate work effectively. 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. 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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. . Salary Range 143,358.00 USD - 173,256.00 USD
    $113k-142k yearly est. Auto-Apply 10d ago
  • R&D Access & Use Evidence Generation AI Use Case Delivery - Grad Intern

    Amgen 4.8company rating

    Remote

    Career CategoryCollege JobJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. R&D Access & Use Evidence Generation AI Use Case Delivery - Grad Intern What You Will Do Let's do this. Let's change the world. During this program, you will [support strategic exploration of artificial intelligence (AI) opportunities within the Access & Evidence Generation ecosystem. This internship will focus on identifying, structuring, and prioritizing AI use cases across real-world evidence (RWE), payer evidence generation, evidence operations, evidence strategic planning and performance management. The intern will conduct a structured assessment of current-state processes and future-state opportunities, developing end-to-end AI use case scenarios and associated business cases. This role is conceptual and strategic in nature and does not require model development or software engineering. It is well suited for a graduate student with strong analytical thinking, business acumen, and interest in applied AI in a regulated life sciences environment]. Assess the current state of Access & Evidence Generation processes, including RWE generation, payer evidence, evidence operations, and strategic planning. Identify and articulate AI opportunity areas across the evidence lifecycle (e.g., automation, augmentation, decision support, optimization). Develop end-to-end AI use case scenarios, including: Problem statement and business context, Target users and workflows AI capability description (e.g., predictive analytics, NLP, decision intelligence) Expected value and outcomes Assumptions, dependencies, and constraints Create business cases for proposed AI use cases, including: Value drivers (efficiency, quality, scalability, decision impact) Qualitative and, where possible, quantitative benefit estimates High-level feasibility and risk considerations (data, governance, compliance) Conduct use case prioritization based on value, feasibility, and strategic alignment. Synthesize findings into clear, executive-ready deliverables, including written analyses and presentation materials. Collaborate with Medical Affairs Operations and relevant stakeholders to validate assumptions and refine recommendations. What We Expect of You We are all different, yet we all use our unique contributions to serve patients. The individual we seek is deeply excited about AI and solving manual workflow with automation using AI. They are creative, curious and self-motivated.: Basic Qualifications: Amgen requires that all individuals applying for a grad internship at Amgen must meet the following criteria: 18 years or older Graduated with a bachelor's degree from an accredited college or university Currently enrolled in an MBA program for an MBA internship OR a Master's program for a Master's internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Master's OR Pharm D OR Ph.D. program before the internship starts Enrolled in an accredited college or university following the potential internship Must not be employed at the time the internship starts Student must be located in the United States for the duration of the internship. Preferred Qualifications: Experienced with ‘use case' development, in a graduate program focused on data science/analytics Familiarity with one or more of the following: Real-world evidence (RWE) or Health Economics outcomes research (HEOR),Market access or payer evidence generation, Medical Affairs or evidence operations Exposure to AI concepts such as machine learning, natural language processing, or decision intelligence (conceptual understanding sufficient). Experience developing business cases, strategy frameworks, or process analyses. Comfort working in ambiguous problem spaces and structuring open-ended questions 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. The base pay range for this opportunity in the U.S. is $30-$40 per hour Build a network of colleagues that will endure and grow throughout your time with us and beyond. Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. Participate in executive and social networking events, as well as community volunteer projects. Apply now and make a lasting impact with the Amgen team. careers.amgen.com - Please search for Keyword R-234081 In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed. 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. . Salary Range -
    $30-40 hourly Auto-Apply 10d ago
  • Clinical Development Scientist - Lilly Gene Therapy, Sensory

    Eli Lilly and Company 4.6company rating

    Remote

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Role Overview The Clinical Development Scientist is a clinical trialist with clinical trial experience responsible for management of clinical supply (in collaboration with Supply Chain) and implementation of clinical supply/device trainings (in collaboration with other functional areas) for global clinical programs. They will be responsible for development of training materials and ensure timely planning and implementation of clinical supply/device trainings. The Clinical Development Scientist will also collaborate cross-functionally to support the clinical and scientific execution of all Lilly Gene Therapy clinical and preclinical programs, as needed. They will ensure timely planning, implementation, management, and reporting of clinical studies and trials. The successful candidate will collaborate cross-functionally to support all Lilly Gene Therapy Sensory clinical programs and provide clinical/scientific support to clinical trial sites and CROs. Responsibilities: Develop and manage updates of trial documents related to clinical supplies Develop training materials for clinical supply training sessions for clinical trial sites and CROs (if applicable) and manage the training material updates Collaborate both internally and externally to facilitate clinical trial site activities to ensure sites are ready for dose administration at site activation and throughout the trial Lead the efforts to conduct training sessions related to clinical materials and supplies Serve as the clinical development representative to work with Clinical Supply Management in supply management, demand forecasting, shipment operation/logistics, etc. Serve as the clinical/scientific representative for assigned clinical trials, as well as program teams, and facilitate the clinical/scientific execution of clinical and preclinical programs, as needed Support the clinical operations team, including clinical trial manager, in achieving trial deliverables, including adherence to budget and timelines, and developing trial documents, procedures, and plans Support authorship and review of clinical/regulatory documents ( e.g ., clinical protocols, Investigator Brochures, clinical study reports, briefing packages, etc.); collaborate cross-functionally in planning regulatory strategy and communications Other duties as assigned or as business needs require Basic Qualifications: Bachelor's degree in the Life Sciences required A minimum of two (2) years of pharmaceutical and/or clinical experience Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role Additional Skills / Preferences: Master's or higher level degree preferred (ie. PharmD, PhD, etc,..) Global clinical trials in the rare disease area Clinical/investigational pharmacy with gene therapy products or clinical supply management Prior pharma/biotech or academic experience in rare disease, otology, audiology, gene therapy, cellular therapy, and/or medical device preferred Proven track record of successfully conducting/supporting clinical trials and associated development activities Comprehensive understanding of the drug development and approval processes, and clinical trial design Strong interpersonal skills required Strong problem-solving skills, including the ability to identify and evaluate the critical factors of obstacles or opportunities; given background, experience, and judgment, able to understand potential causes and deliver potential solutions Ability to plan and think strategically and critically; intellectually curious, willing to take ownership of the assigned tasks and support clinical/pipeline programs, as needed Ability to critically evaluate and analyze scientific data and literature Strong communication skills (written and verbal) including the ability to express oneself clearly and concisely, and to message and document key progress and challenges appropriately; excellent presentation skills required Capable of representing Lilly Gene Therapy professionally with external global opinion leaders, investigators, vendors, regulatory agencies, and others Ability to work effectively cross-functionally, and to serve as clinical resource within the company Self-motivated and detail-oriented with ability to prioritize and handle multiple projects Additional Information: Travel may be up to 15%, including international travel Location: USA Remote Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $154,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $63k-154k yearly Auto-Apply 9d ago
  • Undergrad Intern - Inclusive Global Health and Impact (Summer 2026)

    Amgen 4.8company rating

    Remote

    Career CategoryCollege JobJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Undergrad Intern - Inclusive Global Health and Impact (Summer 2026) What You Will Do Let's do this. Let's change the world. This internship will be approximately 12 weeks and includes both project-based and experiential learning. The intern will be an integral member of the Amgen Inclusive Global Health and Impact (IGHI) Team, which is dedicated to embedding impact at every step of the value chain-from molecule to market-by uniting science, strategy, and multi-sector partnerships As a member of Amgen's IGHI Team, your work will be highly collaborative across multiple teams and levels within Amgen, including Representation in Clinical Research (RISE), Access to Health (ATH), and Health Impact. Additionally, you will have the chance to work cross-functionally with Research & Development, Corporate Affairs, Government Affairs, Health Equity, Advocacy Relations, Diversity, Inclusion & Belonging, and others. You will be uniquely responsible for one or more key projects that will advance the IGHI mission, including the following: Developing a project charter to map out objectives and identify key stakeholders, timelines, and deliverables Leveraging your analytical, leadership, communication, and interpersonal skills to work in teams, identify problems, conduct research, develop recommendations through qualitative and quantitative analysis, and deliver final projects Presenting your deliverables/findings through various forums including an intern-wide poster session and a final readout to executive management You will also be engaged in learning activities, networking with colleagues across the company, and enjoying full access to Amgen's Employee Resource Groups What We Expect of You We are all different, yet we all use our unique contributions to serve patients. The collaborative individual we seek is hard-working with these qualifications: Basic Qualifications: Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria: 18 years or older Currently enrolled in a full-time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent Completion of one year of study from an accredited college or university prior to the internship commencing Enrolled in a full-time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university Must not be employed at the time the internship starts Student must be located in the United States for the duration of the internship OR co-op Preferred Qualifications Pursuing a degree in Health Sciences, Psychology, Sociology, Communications, Business Administration, Public Health or a similar field Strong written and verbal communication skills Strong interest in public health, community health, social sciences, health equity, health policy, health communications, DEI (diversity, equity and inclusion), and/or other related fields Strong organization and time management skills 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. The base pay range for this opportunity in the U.S. is $24.70 - $28.30 per hour. Build a network of colleagues that will endure and grow throughout your time with us and beyond. Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. Participate in executive and social networking events, as well as community volunteer projects. Apply now and make a lasting impact with the Amgen team. careers.amgen.com Please search for Keyword R-231691 In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed. 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. . Salary Range -
    $24.7-28.3 hourly Auto-Apply 38d ago
  • Director - Clinical Research Scientist - Immunology/Gastroenterology Development

    Eli Lilly and Company 4.6company rating

    Remote

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $338,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $93k-127k yearly est. Auto-Apply 10d ago

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