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About Wakefern Wakefern Food Corp. is the largest retailer-owned cooperative in the United States and supports its co-operative members' retail operations, trading under the ShopRite®, Price Rite®, The Fresh Grocer®, Dearborn Markets®, Fairway Markets®, Gourmet Garage®, and Morton Williams® banners. Employing an innovative approach to wholesale business services, Wakefern focuses on helping the independent retailer compete in a big business world. Providing the tools entrepreneurs need to stay a step ahead of the competition, Wakefern’s co-operative members benefit from the company’s extensive portfolio of services, including innovative technology, private label development, and best in class procurement practices. The Quality Assurance Supplier Compliance Auditor is responsible for managing compliance programs for Wakefern Own Brands suppliers. This role develops and maintains an approved supplier program based on regulatory and corporate requirements to mitigate risk and ensure Wakefern and its Members source from vendors that meet established standards. The position focuses on ensuring food safety and quality expectations are met through on-site supplier audits, documentation reviews, and corrective action management. Responsibilities include investigating consumer complaints and recalls/withdrawals, coordinating with internal teams, and supporting the supplier selection processes. Strong knowledge of FDA, USDA, GFSI standards, HACCP, GMPs, SOPs, and third-party certifications (GLOBAL G.A.P, PrimusGFS, BRC, and SQF) is essential. Essential Functions • Reviews and maintains supplier documentation and audit results within the Supplier Management program., • Actively participates in supplier quality related communication and feedback. This includes ownership of the escalation process for nonconforming product, ensuring root cause analysis and corrective solutions are identified and implemented with closure plans., • Participates in supplier selection process for food safety and quality., • Follows-Up on consumer complaints/recalls/withdrawals related to private label product, regulatory issues and coordinates with the Consumer Affairs divisions with appropriate action., • Schedules and confirms audit date with the Supplier., • Prepares and sends supplier audit plan according to protocols., • Adheres to all quality and code of conduct standards., • Conducts audits using applicable checklists, reports, and tools available., • Maintains positive Supplier relationships and responds to all Supplier inquiries and concerns., • Submits complete and accurate audit reports within established timelines to Manager., • Ensures thorough Supplier records are maintained., • Handles multiple projects/tasks simultaneously and within required time schedules., • Maintains up to date knowledge of applicable compliance regulations and standards. Qualifications • Bachelor’s degree in Food Science preferred or similar Science degree., • Seven (7) years of experience in QA/QC processes in a food and/or regulatory industry., • Demonstrated knowledge in FDA and USDA regulations in all related commodities including Seafood., • Demonstrated knowledge in conducting risk assessments, audits, Food GMPs, SOPs, HACCP/Food Safety and environmental guidelines., • Demonstrated Knowledge in the Global Food Safety Initiative (GFSI) Auditing Scheme highly preferred., • SQF Practitioner and/or SQF Internal Auditor Certification highly preferred., • Accredited minimum 16 hour HACCP training., • Self-motivated and strong analytical / problem solving skills., • Experience working in cross-functional teams with significant experience in auditing products, operations and processes are key qualifications of this position., • Familiarity with the third-party certification process (GLOBAL G.A.P, PrimusGFS, Harmonized GAP, Primus Standard, BRC and SQF)., • Effective communication and customer service skills., • Well-developed organizational and time management skills., • Strong computer skills, including Excel, Word, Outlook, and Database systems., • Required to travel up to 80%, mostly overnight travel throughout the U.S. and possibly international., • Spanish verbal proficiency, preferred: must be able to conduct field interviews with agricultural workers, address hygiene practices, and discuss basic agricultural topics including harvesting procedures, chemical handling and personal protective equipment use. Working Conditions & Physical Demands • This position is primarily field‑based (approximately 80%) with remaining time spent performing administrative and computer‑based work (approximately 20%). The position requires regular travel to audit sites by car and/or plane. The incumbent must be able to communicate effectively in person and by phone. Travel and fieldwork involve the ability to stand, walk, and carry up to 25 pounds of equipment, including navigating uneven or steep terrain as needed., • While auditing/assessing, • Open agricultural fields and orchards; food and non-food handling and storage facilities, • Moving tractors, farm machinery as well as standard processing and packing equipment, • Temperature extremes of high heat or cold Core Competencies • Communicate Effectively: Communicates thoughts and ideas in a well-organized manner, encouraging two-way communication., • Build Relationships: Creates cross-functional partnerships through the development and maintenance of constructive and cooperative relationships., • Stay Competitive: Demonstrates a mindset of continuous improvement while exhibiting passion and enthusiasm for their work., • Embrace Change: Looks for new ways of working by supporting advancements in processes and technology., • Develop You: Identifies and capitalizes on opportunities for personal and professional career growth., • Drive for Results: Supports divisional and strategic objectives through achievement of work goals. Compensation and Benefits The salary range for this position is $81,000 to $105,000. Placement in the range depends on several factors, including experience, skills, education, geography, and budget considerations. Wakefern is proud to offer a comprehensive benefits package designed to support the health, well-being, and professional development of our Associates. Benefits include medical, dental, and vision coverage, life and disability insurance, a 401(k) retirement plan with company match & annual company contribution, paid time off, holidays, and parental leave. Associates also enjoy access to wellness and family support programs, fitness reimbursement, educational and training opportunities through our corporate university, and a collaborative, team-oriented work environment. Many of these benefits are fully or partially funded by the company, with some subject to eligibility requirements.

About the Company: Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY Reporting to the Sr. Director of Executive Management & Government Affairs, will serve as a key partner within the Office of the CEO, supporting enterprise-wide strategic initiatives, executive decision-making, and cross-functional execution. This role will act as a force multiplier to the CEO Office by driving structured analysis, managing high-impact projects, coordinating cross-departmental priorities, and supporting public affairs and external advisory engagements. The ideal candidate is highly analytical, detail-oriented, politically astute, and capable of operating in a fast-paced, high-visibility executive environment. KEY ROLES AND RESPONSIBILITIES • Executive Strategy & Decision Support, • Provide structured analytical support to the CEO and Chairman (COB) on high-priority business issues., • Develop executive-level briefing materials, board presentations, and strategic recommendation documents., • Conduct financial, operational, and market analyses to inform leadership decisions., • Track and systematize key corporate KPIs and executive dashboards., • Enterprise Project Management & Cross-Functional Coordination, • Support enterprise-wide strategic initiatives by establishing milestone tracking and governance frameworks., • Facilitate cross-functional alignment across commercial, medical, regulatory, finance, and operations teams., • Identify risks, bottlenecks, interdependencies and escalate issues proactively., • Prepare periodic executive progress reports and performance summaries., • Drive Process optimization efforts to improve organizational efficiency and reduce silos, • Public Affairs & External Advisory Support, • Support management of external advisory firms, consultants, and lobbying partners., • Conduct regulatory and policy research and assist in risk monitoring activities., • Prepare briefing materials for government relations and strategic stakeholder engagements., • Maintain structured documentation and tracking of external engagements and outcomes. Prepare daily/weekly/monthly distribution related reports and analyze to monitor performance, • Strategic & Special Projects, • Support planning and execution of high-impact strategic initiatives and confidential executive projects., • Develop business cases, scenario analyses, and financial models., • Conduct competitive intelligence and industry benchmarking., • Ensure disciplined execution from project initiation through post-implementation review. WORK EXPERIENCE • 1–3 years of professional experience in corporate strategy, consulting, business operations, project management, finance, healthcare, or related fields., • Experience supporting cross-functional initiatives or participating in multi-departmental projects., • Exposure to executive-level reporting or presentation preparation preferred but not required., • Experience in regulated industries (e.g., healthcare and biopharma) is a plus., • Internship or early-career experience in strategy, analytics, or operations roles will be considered., • Bilingual, Korean preferred. QUALIFICATIONS • Strong analytical and problem-solving skills with the ability to structure ambiguous issues., • Proficiency in Microsoft PowerPoint and Excel; ability to build clear, data-driven presentations., • Strong written and verbal communication skills., • High attention to detail and organizational discipline., • Ability to manage multiple tasks and prioritize effectively in a fast-paced environment., • Demonstrated ownership mindset and willingness to learn., • Ability to handle sensitive information with discretion EDUCATION • Bachelor’s Degree required in business or related field CORE COMPETENCIES • Strategic Thinking – Ability to connect operational details to enterprise-level strategy., • Executive Communication – Clear, concise, board-ready communication skills., • Analytical Rigor – Data-driven mindset with strong quantitative capability., • Project Discipline – Structured planning, milestone tracking, and accountability management., • Organizational Influence – Ability to navigate complex stakeholder environments without formal authority., • Discretion & Integrity – High ethical standards and confidentiality in handling sensitive information., • Agility & Ownership – Comfortable operating in ambiguity with strong execution bias. Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDRD

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Associate Director, Health Authorities will aid the advance of global clinical regulatory compliance for investigational and marketed products and manage the preparation, review, and finalization of submission packages and responses to Health Authorities. This position will contribute to the preparation of INDs, CTAs, BLAs, MAAs, and any other application for health authorities in line with local requirements. Essential Functions • Lead Health Authorities direct reports by delegating projects, establishing and meeting timelines, and ensuring high quality work products, • Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance., • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document, • Provide input to the design and reporting of clinical studies sponsored by IBRX, • Manage the preparation of the relevant clinical sections of written summaries for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and any other applications., • Create and maintain project plans for health authorities operations, • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies, • Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, and subject matter experts / key opinion leaders to gather data, craft highquality RFI responses, and foster constructive agency relationships, • Prepare and assign responses to Health Authority comments and questions pertaining to clinical issues. Maintain timelines on responses and assemble the final, completed submission package., • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Ensure continuous monitoring of, and incorporation of, the most recent regional and local healthauthority guidances; interpret amendments and apply updated requirements to all regulatory dossiers to mitigate agency queries and preserve submission integrity, • Oversee versioncontrol governance by supervising a centralized document repository, defining namingconvention standards, authorizing changetracking procedures, and approving final module versions prior to electronic upload to ensure auditready documentation, • Develop and maintain productdevelopment road maps based on projected approval dates, • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required., • Experience managing staff required, • Experience in the management and preparation of the submission of clinical modules in eCTD format required., • Experience in medical writing, • Experience with organizing responses to Health Authority information requests required., • Experience with regulatory submissions outside of the US preferred Knowledge, Skills, & Abilities • Expert knowledge of Health Authority guidance documents and requirements, • Strong leadership skills with the ability to direct and develop professional staff, • Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Expert knowledge of clinical documentation, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail, • Ability to successfully manage multiple changing deadlines and operate in ambiguity Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval, • This position may need to sit for long periods of time and use various computer programs, • This desk-based role involves the close study of scientific and regulatory documents, • This position will work closely with scientific colleagues throughout the day, often on a project-team basis This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $185,000 (entry-level qualifications) to $203,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. QuidelOrtho is seeking a Manager, Data Analytics. The Manager, Data Analytics is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across Quality disciplines. operate under little to no direct supervision and provide independent guidance to the business. This position is considered a subject matter expert in Quality Data Analytics and Complaint Trending. They are accountable for the work of the Quality Data Analytics team and the success of team projects; and will have significant amounts of critical organizational and technical knowledge. This leader is responsible for the day-to-day management and supervision of Quality Engineers and Data Analysts and is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Manager, Data Analytics ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be Hybrid in any global QuidelOrtho site. * Provides independent guidance to business partners on quality data handling and analytics. Establish dashboards and data visualizations to support product quality and continuous improvement. * Leads metrics and data analytics work for Complaints, Recalls, NC, CAPA, Audits/Compliance and other areas of Quality. * Ability to manage complaint trending activities and related software system validations * Ability to compile and present quality data and analysis to the business eg: Management Review. * Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives. * Establishclear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. * Provide technical, regulatory, and operational leadership to ensure Quality systemscomply withISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. * Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. * Promote a culture of continuous improvement byidentifyingopportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). * Ensure the teammaintainsa state ofinspectionreadiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. * MonitorQuality performance using metrics and data analytics toidentifyrisks, drive root cause analysis, and implement sustainable improvements. * Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning. * Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders. * Ability to identify and drive process improvements; own process investigations, nonconformance records or corrective actions in response to audit findings. * Perform other work-related duties as assigned. Required: * Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. * 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership. * Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. * Proven ability to lead and develop high-performing teams and build future technical and people leaders * Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. • Excellent collaboration, influence, and communication skills across functional and organizational boundaries., • Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement., • Experience leading in a matrixed, global organization and managing competing priorities effectively., • Commitment to scientific integrity, compliance excellence, and continuous improvement. Preferred: * Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. * Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools. * Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. * Experience supporting or leading Health Authority or Notified Body inspections. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. Typical office or laboratory environment. May involve virtual collaboration across multiple global sites. No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $135,000 to $175,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Veeva RIM Specialist will provide expertise and guidance in the management and publishing of regulatory documents ensuring their conformance with Health Authority requirements. This role is hands on and execution focused, working closely with all of regulatory affairs to support all US and ex-US regulatory activities and maintain inspection-ready system. This position will assist staff in submission and document management activities using Veeva RIM software. Essential Functions • Create and maintain electronic project folders for projects., • Execute the upload, tracking, life cycle maintenance of regulatory submissions, including INDs, BLAs, CTAs, for US and ex-US regions within Veeva RIM., • Maintain Veeva RIM by uploading all submissions, Health Authority correspondence, etc., • Track all regulatory meetings, questions, information requests, and responses ensuring proper linking within Veeva RIM. Upload and manage Word and source documents in Veeva Vault to support collaboration, version control, and document updates., • Ensure regulatory documents received via email, secure links, or external portals in addition to gateway submissions are captured and filed appropriately., • Assist in responding to internal audits, health authority inspections, and regulatory inquiries related to RIM documentation., • Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements., • Configure Vault objects, lifecycles, workflows, document types, and metadata to support business processes., • Provide technical and functional support for users including, but not limited to, access to Veeva RIM, • Assist in system validation, upgrades, and testing, ensuring compliance with GxP and regulatory standards., • Partner with regulatory affairs, IT, and clinical teams to translate business requirements into technical solutions., • Assist in training Regulatory Documentation Specialists, ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed., • Act as a key operational contact for Regulatory Affairs regarding Veeva RIM., • Provide day-to-day support to system users., • Collaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer needed., • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or, • High School diploma with 9+ years' experience required., • Hands on experience with Veeva RIM and Veeva Vault required., • Familiarity with global regulatory submissions and health authority correspondence strongly preferred. Knowledge, Skills, & Abilities • Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission., • Expert knowledge of Electronic Document Management Systems., • Strong knowledge in Veeva Vault especially Veeva RIM., • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities., • Strong organizational skills, written and oral communication skills, and attention to detail. Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves close study of scientific and regulatory documents., • This position will work closely with colleagues throughout the day, often on a project-team basis. This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $50.48 (entry-level qualifications) to $55.53 (highly experienced) per hour The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Job Description Summary #LI-Hybrid Novartis has an exciting opportunity for a Director, Analytics Standards & Impact Measurement. This role is responsible for establishing enterprise-wide standards for advanced AI, ML, and data science rigor, defining measurement frameworks, and quantifying the business impact of all analytics and AI initiatives across Commercial Analytics. By ensuring that analytics outputs, whether built by expert data scientists or citizen data scientists using self-serve platforms, meet the highest standards of AI/ML validity, regulatory compliance, and business value, this director enables democratized, trustworthy analytics at scale while measuring and communicating the return on analytics investments. This position will be located at the East Hanover, NJ site and will not have the ability to be located re-motely. This position will require 15% travel as defined by the business (domestic and/ or international). Job Description Key Responsibilities • Define enterprise-wide AI, ML, and data science standards embedded into self-serve analytics platforms, ensuring citizen data scientists follow rigorous methodologies automatically., • Establish model validation protocols, testing frameworks, and quality gates built into automated workflows for predictive models and AI solutions., • Create standardized methodologies for common use cases (patient predictive models, HCP targeting, driver analysis) that can be templatized for citizen data scientists., • Define enterprise-wide frameworks for measuring analytics impact including lift analysis, ROI calculation, incrementality measurement, and business value assessment., • Execute enterprise-level impact measurement studies to quantify business value of analytics initiatives and report quarterly/annual ROI to leadership., • Establish production-readiness criteria for AI/ML models from self-serve platforms, including quality thresholds, documentation requirements, and approval workflows., • Ensure all AI, ML, and data science outputs meet regulatory requirements ( HIPAA, GDPR, promotional review) and partner with Legal, ERC, and Medical Affairs on governance., • Advanced degree in Data Science, Machine Learning, Statistics, or related quantitative field; or bachelor's degree with 10+ years relevant experience., • 10+ years of experience in data science, machine learning, advanced analytics, or AI development., • 5+ years of leadership experience setting AI/ML standards and measuring impact in commercial pharma or healthcare., • Expert knowledge of advanced analytics methodologies: machine learning, causal inference, experimental design, predictive modeling, AI validation., • Deep knowledge of pharmaceutical analytics and regulatory environment for AI/ML applications., • Proficiency in data science/AI programming and AI/ML platforms., • Proven ability to influence without direct authority and drive adoption of AI/ML standards across diverse teams., • Experience with self-serve analytics and AI platforms and embedding governance into automated workflows., • Strong business acumen with ability to measure and communicate ROI of AI/ML initiatives to C-suite., • Systems thinker who can balance AI/ML rigor with practical business needs and timelines., • Experience building communities of practice and enabling citizen data scientists in AI/ML development. The salary for this position is expected to range between $194,600 and $361,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $194,600.00 - $361,400.00 Skills Desired Agile (Programming Methodology), Artificial Intelligence (AI), Business Value Creation, Change Management, Curious Mindset, Data Governance, Data Literacy, Data Quality, Data Science, Data Strategy, Data Visualization, Deep Learning, Learning Agility, Machine Learning (ML), Machine Learning Algorithms, Mentorship, Nlp (Neuro-Linguistic Programming) And Genai, Organization Awareness, Stakeholder Engagement, Statistical Analysis, Time Series Analysis, Vision, Visualization

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and be responsible for participating in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). Key responsibilities will include contributing to the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards, • Contribute to the development of global CMC regulatory strategies, • Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation, • Provide expert opinion on CMC topics planned or performed, • Contribute to the design of CMC protocols, • Interact with other groups when needed to address CMC related matters, • Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues, • Train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate, • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years relevant progressive experience required, • Experience in the preparation of the submission of CMC modules in eCTD format required, • Familiarity with organizing responses to Health Authority requests required, • Familiarity with regulatory submissions outside of the US desired Knowledge, Skills, & Abilities • Knowledge of Health Authority procedures and guidance regarding document management and electronic submission, • Knowledge of Health Authority CMC guidance documents and requirements, • Proficient in Electronic Document Management Systems, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail, • Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred Working Environment / Physical Environment • This position works on-site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents. $170,000 (entry-level qualifications) to $187,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Manager, Lifecycle Maintenance will advance the maintenance global clinical regulatory compliance for investigational and marketed products and manage the maintenance of study files in eCTD format. This position will contribute to the organization in the design and conduct of clinical trials in conformance with Health Authority requirements and the management of clinical trial documentation to support clinical submissions. Essential Functions • Lead Lifecycle Maintenance staff by delegating projects, establishing and meeting timelines, and ensuring high quality work products, • Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance., • Provide input to the design and reporting of clinical studies performed by IBRX or by CROs, • Manage the review, cataloguing, and submission of documents including investigator brochures, protocols, informed consent forms, clinical study reports, annual reports, DSURs, PSURs, PAERs, and clinicaltrials.gov entries in the US and abroad, • Manage all protocol supportive documentation including the cataloguing and submission of essential investigator qualification documents, • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan, • Create and maintain project plans for regulatory lifecycle maintenance operations, • Monitor FDA and other healthauthority guidance, prepare supplemental dossiers, and manage the lifecycle documentation for postapproval changes., • Lead datadriven strategic initiatives to maintain comprehensive regulatory documentation, ensuring compliance and supporting organizational objectives., • Oversee configuration, maintenance, and user support for internal platforms used for file storage., • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the internal review of the relevant clinical sections of written summaries for regulatory submissions including INDs, NDAs, and BLAs, • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 7+ years relevant progressive experience required; or, • Master's degree in life sciences or technical discipline with 5+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 3+ years relevant progressive experience required, • Experience managing staff preferred, • Experience in the management and preparation of the submission of clinical modules in eCTD format required, • Experience with organizing responses to Health Authority information requests required, • Familiarity with global regulatory submissions (US and ex-US) strongly preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority guidance documents and requirements, • Strong leadership skills with the ability to direct and develop professional staff, • Strong knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval, • This position may need to sit for long periods of time and use various computer programs, • This desk-based role involves the close study of scientific and regulatory documents, • This position will work closely with scientific colleagues throughout the day, often on a project-team basis This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $165,000 (entry-level qualifications) to $181,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Manager, Veeva RIM will provide strategic and strategic leadership and oversight for Veeva RIM. The manager will manage the day-to-day management and operations of Veeva RIM, ensuring accurate, timely, and compliant uploads and maintenance of regulatory submissions and related documentation across US and ex-US regions. This role parents closely with Clinical, Nonclinical, and CMC regulatory teams to support all regulatory activities. This position will assist and direct staff in the use of Veeva RIM software to ensure that all regulatory content, submissions, and processes are managed efficiently, accurately, and in full compliance with global regulations. Essential Functions • Lead the Regulatory Affairs Veeva RIM Team by delegating projects, establishing and meeting timelines, and ensuring high quality work products., • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees, and monitoring performance., • Manage dossier archiving and ensure regulatory data integrity, version control, and audit readiness., • Use Veeva RIM to upload and manage all regulatory submissions (e.g., BLA, IND, CTA), registrations, and archival of documents for both US and ex-US., • Upload, track, and maintain all correspondence with health authorities as well as ethic committees., • Partner with IT, Quality, and clinical on system support activities as needed., • Partner with IT, Quality, and clinical on system validation, upgrades, and testing, ensuring compliance with GxP and regulatory standards., • Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM., • Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates., • Manage documents received but not limited to via regulatory gateways, emails, secure links., • Establish and maintain RIM-related SOPs, work instructions, and best practices., • Lead or support migration of regulatory and submission documents from legacy systems to Veeva., • Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention., • Track regulatory submission, • Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM., • Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates., • Manage documents received but not limited to via regulatory gateways, emails, secure links., • Establish and maintain RIM-related SOPs, work instructions, and best practices., • Lead or support migration of regulatory and submission documents from legacy systems to Veeva., • Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention., • Track regulatory submission renewals, post-approval changes, and ensure timelines are met., • Monitor regulatory guidance and changes, perform impact assessment; communicate changes to cross-functional teams., • Ensure compliance with relevant regulatory requirements (FDA, EMA, ICH, local authorities), • Ensure that all working files and archives are organized and maintained in accordance with SOPs and Health Authority requirements, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications., • Provide user support/training for Veeva workflows; act as tool superuser., • Train and support cross-functional uses on Veeva RIM processes and document standards., • Prepare for internal/external audits, inspections, and data integrity assessments, address findings promptly., • Act as a point of contact for troubleshooting Veeva RIM issues and coordinating with system administrators., • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 7+ years of regulatory operation experience in the biotech or pharmaceutical industry required; or, • High School diploma with 11+ years of regulatory operation experience in the biotech or pharmaceutical industry required., • Familiarity with global regulatory submissions (US and ex-US)., • 2 years of experience managing regulatory documentation using Veeva RIM required., • 2+ years of experience managing staff in support of Regulatory Affairs operations is preferred. Knowledge, Skills, & Abilities • Leadership skills with the ability to direct and develop professional staff, • Strong knowledge of Health Authority guidance documents and requirements., • Strong knowledge of Health Authority procedures and guidance regarding document management and electronic submission., • Strong knowledge of the use of Veeva RIM in document management., • Strong attention to detail and document management skills., • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities., • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $165,000 (entry-level qualifications) to $181,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Job Description Summary #LI-Remote- Location: Remote- At Novartis, an industry leader, you will provide critical medical and scientific leadership across a broad rheumatology portfolio. The Medical Director will play a central role in strategic planning, tactical execution, and budget planning, with a strong emphasis on evidence generation, clinical development support, and scientific communications. This role will drive close collaboration and co leadership with Global and U.S. Medical Affairs, Clinical Development, HEOR, Regulatory, Commercial, and Market Access colleagues to develop and execute integrated evidence plans and scientific communication strategies supporting early pipeline, launch, and in line rheumatology therapies. The Medical Director will serve as a key internal and external scientific leader, partnering with healthcare professionals, investigators, and professional societies to advance data generation, scientific exchange, and understanding of evolving standards of care across multiple rheumatology and rare autoimmune disease areas. Major Accountabilities • Lead the development and execution of integrated evidence generation plans across multiple rheumatology disease states, including Sjogren's disease, lupus, systemic sclerosis, psoriatic arthritis, and rare autoimmune conditions, in partnership with Global and U.S. cross functional teams., • Provide medical leadership and scientific input to clinical development programs, including support for protocol development, study design, data interpretation, and ongoing trial execution and enrollment across early and late phase studies. Partner with Clinical Development, Clinical Operations, and external investigators to drive innovative patient recruitment and retention solutions, supporting the successful enrollment of a large portfolio of Phase 3b studies, while overseeing Investigator Initiated Trials (IITs) and Research Collaboration programs to ensure scientific quality, strategic alignment, and compliant execution., • Develop and implement a comprehensive external medical engagement strategy, including interactions with medical experts, investigators, academic centers, large rheumatology practices, and professional societies, ensuring impactful and compliant scientific exchange., • Collaborate in the establishment and ongoing execution of advisory boards and expert meetings, partnering with cross functional stakeholders to ensure clear objectives, high quality scientific dialogue, and compliance with all applicable guidelines., • Lead the development and execution of scientific communication plans, including congress strategy, publications, external presentations, and scientific materials aligned with evidence and lifecycle strategy., • Drive and coordinate congress medical strategy and execution, including scientific sessions, investigator meetings, and external engagement activities at key U.S. and international rheumatology congresses, in collaboration with Global teams., • Serve as a strategic partner to field medical teams (e.g., MSLs) by providing scientific leadership, aligning on external engagement priorities, and incorporating field insights into medical strategy and evidence planning., • Represent the U.S. Medical voice in internal forums and cross functional governance, providing input into global strategy, evidence planning, and external engagement approaches., • Act as a disease area medical expert for internal stakeholders across functions and for external audiences, including healthcare professionals, professional medical societies, and patient advocacy organizations., • Perform additional Medical Affairs responsibilities as assigned, consistent with business needs and organizational priorities. Key Performance Indicators • Demonstrated ability to collaborate effectively across Global and U.S. matrix teams to co develop and execute integrated medical, clinical, and evidence strategies., • Strength of scientific and strategic thinking, including the ability to translate complex clinical and real world data into clear medical insights that inform development, lifecycle, and scientific communication decisions., • Effectiveness in building and sustaining trusted relationships with external stakeholders, including healthcare professionals, investigators, and professional societies., • Successful contribution to clinical development support, evidence generation, and launch readiness across multiple rheumatology and rare autoimmune disease areas., • Ability to communicate clearly, concisely, and credibly with diverse internal and external audiences, aligning stakeholders around shared medical and scientific objectives., • Consistent delivery of key medical initiatives on time, with high quality, and within budget., • Demonstrated ability to leverage advanced analytics and AI enabled tools to enhance evidence generation, insight synthesis, scientific planning, and operational efficiency, while ensuring appropriate governance, data integrity, and compliance., • Evidence of innovative thinking, including identification and application of novel approaches-such as AI supported literature analysis, data visualization, and insight generation to improve medical strategy and scientific impact., • Consistent adherence to ethical standards and compliance requirements, ensuring all medical activities meet internal policies and external regulatory guidelines. Job Description Education (minimum/desirable): • Doctorate level degree required (MD, PharmD, DO, or PhD in Health Sciences or related field or Nurse Practitioner (DNP)/ Physician's Assistant (PA) degree with significant relevant clinical experience required.) Experience required: • Highly preferred: 3+ years pharmaceutical US Medical Director experience, ideally in immunology and/or neurology. Launch experience with new products and/or new indications. Strong knowledge of immunology and/or rheumatology preferred. • Clinical research experience - including concept and protocol development - conducted in a pharmaceutical environment is strongly preferred., • Solid understanding of clinical trial operations and experience driving patient recruitment solutions, is strongly preferred., • Strong track record of positive, productive interactions with Medical Experts, Investigators, and Professional Societies., • US and European travel required. (25-30% annually)., • Location is flexible as position is remote. The pay range for this position at commencement of employment is expected to be between $204,400 - $379,600 a year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. To learn more about the culture, rewards and benefits we offer our people click ___. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $204,400.00 - $379,600.00 Skills Desired Agility, Agility, Clinical Practices, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation, Medical Affairs, Medical Communication, Medical Education, Patient Care, People Management, Pharmaceutics, Priority Disease Areas Expertise, Product Launches, Product Strategy, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies {+ 4 more}

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format. The Associate Director will have one or more direct reports, will work closely with cross-functional teams on CMC regulatory strategy and regional regulatory requirements, and will consult with CMC subject matter experts (SMEs). Key responsibilities will include the development of Health Authority submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Provide expert opinion on CMC topics planned or performed, • Manage the preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards, • Assist with the development of global CMC regulatory strategies, • Prepare or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation, • Provide expert opinion on CMC topics planned or performed, • Assist with the design of CMC protocols, • Collaborate with other groups when needed to address CMC related matters, • Prepare responses to Health Authority comments and questions pertaining to CMC issues, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance, • Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required., • Experience in the management and preparation of the submission of CMC modules in eCTD format required, • Experience with organizing responses to Health Authority requests required, • Experience with regulatory submissions outside of the US preferred, • Experience managing staff preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority CMC guidance documents and requirements, • Good leadership skills with the ability to direct and develop professional staff, • Expert knowledge of Chemistry, Manufacturing and Controls of a medical product and related regulatory requirements and guidelines, • Expert knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred, • Ability to manage work and staff with firm deadlines and adapt quickly to changing requirements and priorities, • Excellent organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents., • This position will work closely with scientific colleagues throughout the day, often on a project team basis., • This position may also need to travel to meet with Regulatory Agencies, attend conferences, or visit manufacturing sites. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $200,000 (entry-level qualifications) to $220,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Compliance Summer Intern will support the Compliance department in key operational, strategic, and crossfunctional initiatives. This role offers a unique opportunity for a student interested in pharmaceutical compliance, risk management, systems/process implementation, and other operational projects. The intern will gain handson experience working alongside Compliance business partners while contributing to meaningful projects that support Eisai's commitment to ethical business practices and patientcentered decisionmaking. Key Responsibilities • Support system implementation activities, including documenting business requirements, testing new system functionalities, and assisting in user acceptance testing (UAT)., • Assist with policy and training updates, including drafting content, organizing reference materials, and helping prepare communications., • Participate in team meetings and project working sessions., • Currently enrolled in an undergraduate or graduate program in Business, Legal Studies, Public Health, Regulatory Affairs, Life Sciences, Healthcare Administration, or related fields., • Demonstrated interest in compliance, healthcare/pharmaceutical regulation, or corporate ethics., • Strong analytical, organizational, and problemsolving skills., • Excellent written and verbal communication abilities., • Ability to manage multiple tasks, meet deadlines, and collaborate with team members., • How a Compliance department operates within a pharmaceutical organization., • Key elements of healthcare laws, regulatory requirements, and industry standards that govern pharma interactions and operations., • Best practices in governance, monitoring, training development, and risk mitigation., • Practical experience supporting a system implementation or enhancement project., • Direct exposure to real projects that support business needs., • Handson experience in a missiondriven organization committed to patients and ethical conduct., • A blend of operational work, strategic thinking, and professional development., • A strong foundation for students interested in careers in healthcare compliance, regulatory affairs, risk management, or corporate governance. Eisai Salary Transparency Language: The hourly rate for the Compliance Summer Intern (Hybrid - Nutley, NJ) is : $25. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Support regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements for major filings, (IND, NDA, sNDA, Amendments, DMFs, etc.) and regulatory maintenance activities. Support global submission timelines and coordination of publishing activities of work-related experience required for this position. Solid knowledge of submission requirements for regional markets may be required to ensure the overall submission and quality of the dossier meets regulatory compliance. Essential Functions Submission Management & Publishing Tasks: Manage assigned regulatory activity projects and closely collaborates with Senior Managers from GSM, Regulatory Affairs and other functional areas for the planning and publishing of regulatory submissions, monitoring submission forecast and ensuring timely high quality of regulatory submissions are submitted to health authority within required submission timelines. Publishing regulatory submissions (bookmarks, hypertext links, QC) scheduled to be submitted to regulatory agencies (e.g., FDA, EMA and Health Canada). Publishing Tasks: Assists with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types Submission Specialist Tasks: • Responsible for publishing, review, submission compilation and archive for routine regulatory activities (e.g. Amendments) and complex eCTD submissions (e.g. IND, NDA)., • Uses internal and industry best practices in order to ensure quality submission deliverables., • Provide operational oversight to ensure timely, high quality regulatory submissions, • Participates in the development of optimal business processes (internal guides, SOPs, etc.) and practices within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies and advises management with regards to opportunities for efficiencies, business process improvements, and cost reductions., • Position accountability/scope includes supervision of certain projects and assistance with priority setting required. Receives project assignments from manager, but has the responsibility for independently managing and executing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up., • Identifies opportunities and advises management for process improvements or cost savings. May participate on internal project teams in order to guide and update business processes., • Supports various document management assignments, including file transfer, archiving, tracking, and archival of Regulatory submission documentation (including SPL, FDA correspondence and submission)., • Demonstrates team leadership skills and ability to positively influence and work with others. Builds and maintains positive relationships internally and externally., • Participates in other key projects and activities as assigned by management to support the Regulatory Operations function including submission authoring and Regulatory Systems implementation projects. Publishing Tasks: Assist with hands-on daily submission compilation and publishing activities associated with preparation of various regulatory submission types. Applies good judgment and demonstrates initiative to resolve issues. • Expert understanding of Project Management tools and techniques., • Ensures publishing activities are processed in accordance with established SOPs., • Collaborate timeline with the regulatory affairs representatives, maintains the submission timelines, obtain status updates from the Publishing Manager and subteam members, RA Leads and reports submission status and activities to various stakeholders., • Update the regulatory submission calendar, and reports on key submission milestones to stakeholders, as applicable. Business Process Development & Problem Solving: • Participate and contribute to new and updated process and procedures. Review regulatory documents to ensure compliance with submission guidelines to drive efficient future state process including gaining buy in for key stakeholder and drive to standardization of processes., • Identifies risks and opportunities and addresses as needed with a focus on regulatory compliance requirements by supporting best practices, Working Procedures and SOPs., • Support process updates due to changing regulations that impact submission strategies and technologies, SEND, CDISC, Validator Software, etc. This includes not limited to identifying the validation checks needed to ensure compliance with eCTD Specifications for world-wide regulatory agencies., • May participate on internal project teams in order to guide and update business processes, as applicable. Regulatory Information Applications & Technology: • Support technology activities to ensure that regulatory information applications and systems are implemented, validated, and maintained in accordance with regulatory requirements compliance including but not limited to performing UAT scripts)., • Support Global System development and process development on a basic level, and process redesign., • Technical knowledge of the US and global regulatory requirements for electronic submissions Regulatory Training: Support and coordinate training to global submission management, regulatory publishing and other functional areas. Regulatory Submission Intelligence: Perform and collect regulatory information applicable to global electronic submissions guidance, publishing tasks, data standards, and technology and marketing trends in regulatory space. Ability to gather data, analyze research material information and communicate to management potential impact on regulatory operations strategies, and/or identify hot topic issues. Responsible for staying abreast of US, Harmonized (ICH) eCTD and Global guidances, and provide updates as required Requirements • Bachelor's Degree required, preferably in science or health related discipline, • Minimum 3-5 years pharma experience, including at least 1-2 years submission experience, • Experience regulatory professional that understands regulatory submission/ePublishing requirements for filing original applications, amendments, complex supplements/variations and line extensions, as well as routine submissions., • Excellent communication skills required to interact effectively with regulatory affairs members and regulatory colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues with diplomacy and tact., • Applies good judgment and demonstrates initiative to resolve issues., • Advance understanding of Submission Project Management tools and techniques., • Ensures submissions are processed in accordance with established SOPs., • Excellent analytical and problem solving skills: facilitating team(s) to identify issues and propose solutions with respect to regulatory eCTD submission issue, • Strong Communication Skills: Excellent verbal and written communication skills with demonstrated ability to present and articulate requirements with regulatory affairs members and regulatory colleagues proactively. Ability to foster and maintain relationships with strategic global regulatory organization and other functional partners to ensure understanding of current processes., • Project Management Skills: Strong project management skills with attention to detail, ability to work in a fast-paced environment while successfully prioritizing and working on multiple tasks while utilizing organizational skills., • Knowledge of Drug Development: Experience in regulatory operations or regulatory affairs with advanced knowledge of pharmaceutical development (e.g. CMC, Nonclinical, Clinical), • Technology & Software Skills: Advanced working knowledge of global eCTD publishing and Electronic Document Management technology, ISI Toolbox, Regulatory Tracking Systems (RTS) and related technology applications. Advanced user skill in MS Word, MS Sharepoint, Adobe Acrobat Professional, eCTD content templates and experience., • Teamwork Skills: Experience in working on teams and to establish effective relationships with team members., • Critical Thinking and Problem Solving Skills: Ability to track regulatory eCTD submission changes (e.g. regional DTD upgrade or system upgrades) and interpret potential implications for regulatory activities, training and/or timelines. Ability to identify the root cause of problems as well as the implications associated with potential solutions and communicate to management. Eisai Salary Transparency Language: The annual base salary range for the Senior Associate, Global Submission Management is from :$82,500-$108,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS: Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title., • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred., • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs., • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory., • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Alzheimer's Disease (Northern CA) - Field Based is from :$160,100-$210,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS: Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title., • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred., • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs., • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory., • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the MSL/Senior Medical Science Liaison, Neurology (Alzheimer's Disease) - Field Based, Northern and Central Florida - Field Based is from :$165,300-$216,900 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Profile Summary The Associate Director, Medical Information Oncology, is responsible for leading and driving Global & US Medical Information activities for assigned therapeutic area(s) to meet the Eisai product information needs of external customers and internal business partners. This role is seen and sought after for their subject matter expertise in Oncology and assigned therapeutic area(s) and serves as medical reviewer of Eisai's advertising, promotional, and scientific exchange materials as part of Copy Review Committee and Medical Review Committee. Beyond traditional responsibilities, this position offers a unique opportunity to optimize and communicate medical information insights as part of a broad, cross-functional strategic team, ensuring these insights inform decision-making and drive innovation across the organization. The Associate Director will also leverage and implement AI-driven tools and capabilities in new and transformative ways, enhancing efficiency, personalization, and scalability of medical information services. The AD, Medical Information contributes to the development and implementation of medical plans, including the creation of standard medical responses, development of AMCP dossiers, compendia submissions, and other medical information deliverables. This role is also responsible for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to performance improvement activities, conducting quality monitoring, tracking and reporting of medical information insights and metrics, ensuring regulatory compliance, inspection readiness, and appropriate documentation and reporting of product incident reports. Responsibilities (Expanded) * Develop and manage tactical execution of the Medical Information component of Global & US Medical Affairs strategic plans for assigned therapeutic area(s). * Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; conduct quality assurance measures and handle escalated inquiries as needed. * Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, AMCP dossiers, compendium and pathways submissions, etc. * Serve as medical reviewer, ensuring medical accuracy and provision of feedback for Eisai's advertising, promotional, and medical materials as part of Copy Review Committee and Medical Review Committee. * Lead and provide oversight of department reporting processes, KPIs, insights analytics, digital analytics, and other trend reports that are shared with internal stakeholders; proactively identify opportunities to optimize insights for strategic decision-making. * Explore and implement AI-driven tools and technologies to enhance medical information processes, improve efficiency, and deliver innovative solutions for internal and external stakeholders. * Liaise with global and regional medical affairs colleagues as appropriate. * Provide strong scientific support for conference and booth coverage. * Implement and participate in department training, process and performance improvement activities, quality monitoring, metrics tracking, regulatory compliance, inspection readiness, and product incident response. * Serve as a business partner to internal and external collaborators as needed to support scientific exchange activities and address critical escalations as warranted. * Provide mentoring, guidance, and training to new hires/less experienced colleagues. * May provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate. * Travel required up to 30% of time. * Hybrid based in Nutley, NJ (in office Tuesday, Wednesday and Thursday) Qualifications: * Advanced degree in sciences or related field with 10+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience. * Strong scientific knowledge and expertise in Oncology, including evaluating and communicating clinical trial and disease state information to a wide range of audiences. * Demonstrated experience in conducting scientific literature review, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, dossier, compendium submissions, etc.) * Practical experience and knowledge of FDA guidance on appropriate scientific exchange practices. * Previous experience of managing/leading teams directly/indirectly or coaching and mentoring new hires/less experienced colleagues. * Proficiency with Microsoft Office Suite software, SharePoint, Veeva, customer relationship management software, and other technology and telephony systems. Additional Preferred Qualifications: * Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights. * Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions. * Strong understanding of data visualization and insights reporting to support strategic decision-making. Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Medical Information, Oncology is from :$164,600-$216,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Senior Medical Information Manager is responsible for contributing to the development and implementation of the Medical Information component of the strategic plan for their assigned therapeutic area. In addition, the Senior Medical Information Manager leads cross functional teams and initiatives to support Medical Affairs and business objectives. Responsibilities:* Respond to unsolicited medical inquiries from healthcare professionals, patients/consumers, field staff and other internal business partners.* Develop and manage tactical execution of the Medical Information plan for their assigned therapeutic area.* Utilize scientific expertise to lead the development and maintenance of medical information resources for assigned products to meet the needs of external customers and internal business partners.* Conduct detailed analyses of scientific literature to communicate relevant scientific information and competitive issues with Medical Affairs colleagues, cross-functionally and globally.* Implement Medical Information component of strategic medical plans for assigned products, including implementing performance improvement activities, service quality monitoring, and tracking and reporting of metrics.* Serve as POC for medical and scientific review of promotional and scientific exchange materials in CRC and MRC in collaboration and partnership with Medical Directors.* Provide inputs to the overall development of budget and resources and escalate deviations, as needed.* Analyze metrics and develop insights reports on Medical Information activities presented to internal stakeholders.* Provide scientific support for assigned stakeholders on ad hoc projects and/or initiatives, including at Medical Information Booths for assigned medical conferences.* Provide supervisory guidance, training to new hires/ less experienced colleagues and/or mentorship to pharmacy students. Qualifications:* Advanced degree in sciences or related field with 8+ years of experience in the pharma/ biotech industry.* OR a combination of equivalent education and experience.* Advanced knowledge of U.S. regulatory standards related to pharmaceutical manufacturers' communications and dissemination of medical information.* Knowledge of clinical trials, drug approval processes, and clinical application of drug products.* Prior experience in medical writing and development of scientific communication materials.* Some experience coaching and mentoring new hires/ less experienced colleagues.* Proficiency with Microsoft Office Suite software, Sharepoint, Veeva, customer relationship management software and other technology and telephony systems.* Proven performance in earlier role.* Able to travel as needed (approximately 10% on average)* Hybrid, onsite in Nutley NJ, 3 days a week (Tuesday, Wednesday and Thursday) Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Senior Manager, Medical Information, Oncology is from :$130,500-$171,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Regulatory Affairs Program Manager leads crossfunctional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and are launched on schedule. This role partners closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission timelines, and drive successful product approvals worldwide. Essential Functions • Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies., • Function as a Regulatory Affairs point of contact for internal teams, translating regulatory requirements into clear and actionable objectives., • Coordinate crossfunctional project teams, ensuring alignment with regulatory objectives and strategy. Track and report program status to senior leadership and external partners., • Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards. Assess impact on products/processes and communicate findings., • Identify risks early, develop mitigation plans, and resolve issues that could impact timelines or approvals., • Foster a culture of continuous improvement and regulatory excellence., • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates., • Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in sciences, business, project management or a related field with 7+ years of relevant progressive experience is required., • 5+years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred., • 3+years managing complex, multiregional regulatory programs is preferred. Knowledge, Skills, & Abilities • Understanding and knowledge of FDA and other major healthauthority requirements, a plus., • Proven ability to work with crossfunctional teams, manage budgets, and deliver on schedule., • Excellent written and oral communication skills., • Strong analytical and problemsolving abilities., • Proficiency with MS Office suites and project management tools. Working Environment / Physical Environment • This position works on-site, • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer., • Lift and carry materials weighing up to 30 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $141,300 (entry-level qualifications) to $157,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Title: Chief Compliance Officer Department: Office of Institutional Compliance Reports To: General Counsel, Senior Vice President of Legal Affairs and Secretary to the Board of Trustees Position Type: Staff Position Summary: The Chief Compliance Officer (CCO) serves as the senior executive responsible for overseeing and managing compliance with federal, state, and local laws and regulations as well as university policies and procedures. Reporting to the General Counsel, the CCO provides leadership in the development, implementation, and oversight of a comprehensive university-wide compliance program. This position ensures the university maintains a culture of compliance, ethical conduct, and risk awareness while fulfilling its academic and research mission. Essential Functions: Compliance Program Leadership: -Develop, implement, and maintain an effective, risk-based university compliance program. -Lead the coordination of compliance efforts across academic, administrative, and research units. -Monitor and report on the effectiveness of the compliance program to senior leadership and relevant university committees. Regulatory Oversight & Risk Management: -Ensure compliance with applicable laws and regulations (e.g., FERPA, Title IX, Clery Act, HIPAA, NCAA, ADA). -Partner with university stakeholders to assess and manage institutional compliance risk. -Stay abreast of regulatory changes and update compliance policies, procedures, and training accordingly. Training and Awareness: -Develop and deliver regular compliance training and education to faculty, staff, and students. -Promote a culture of ethics and compliance across the university community. Investigation and Reporting: -Oversee and coordinate internal investigations into reports of non-compliance or misconduct. -Maintain a confidential reporting system and ensure reports are addressed appropriately and promptly. -Prepare periodic compliance reports for the Board of Trustees and executive leadership. Policy Development and Review: -Lead or assist in the creation and revision of university-wide compliance-related policies and procedures. -Ensure alignment of policies with best practices and regulatory requirements. Collaboration and Leadership: -Serve as chair or member of university compliance-related committees. -Act as a liaison with external agencies on compliance matters and audits. -Provide expert guidance to university leadership on compliance risks and mitigation strategies. Other duties as assigned. Prerequisite Qualifications: -Education: Juris Doctor (JD) or advanced degree in law, compliance, public policy, higher education administration, or a related field required. -Experience: Minimum of 8-10 years of progressive experience in legal, compliance, or regulatory roles, preferably within a higher education, healthcare, or public sector setting. -At the university's discretion, the education and experience prerequisites may be exempted where the candidate can demonstrate to the satisfaction of the university, an equivalent combination of education and experience specifically preparing the candidate for success in the position. Preferred Qualifications: -Experience working in a university general counsel's office or comparable environment. Skills and Competencies: -Deep knowledge of laws and regulations affecting higher education institutions. -Proven ability to lead compliance initiatives in a complex university environment. -Exceptional communication and interpersonal skills. -Strong ethical judgment, discretion, and integrity. -Ability to work independently in a fast-paced environment. -Proficiency with compliance tracking tools and systems. Bargaining Unit: Non-Aligned Range/Band: 5 Salary Information: In compliance with the NJ Pay Transparency Law, the annual salary range for this position is $130,000-$150,000 (USD). NJIT considers factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/training, key skills, internal peer equity, as well as, market and organizational considerations when extending an offer. This pay range represents base pay only and excludes any additional items such as incentives, bonuses or other items. To learn more about the comprehensive benefits NJIT offers for this position, please visit our benefits page: . FLSA: Exempt Full-Time Travel: -<5% Apply NowShare Save Job

Minimum 2 years of experience in risk management, compliance, regulatory affairs, or related field. Experience supporting regulatory examinations or compliance engagements in financial services. Regulatory Strategy Senior Officer (Associate).

A leading fragrance and flavor company is seeking a Regulatory Affairs Technical Senior Manager to ensure compliance with chemical regulations, including TSCA and CEPA.

Job DescriptionCoreWeave is The Essential Cloud for AI™. Built for pioneers by pioneers, CoreWeave delivers a platform of technology, tools, and teams that enables innovators to build and scale AI with confidence. Trusted by leading AI labs, startups, and global enterprises, CoreWeave combines superior infrastructure performance with deep technical expertise to accelerate breakthroughs and turn compute into capability. Founded in 2017, CoreWeave became a publicly traded company (Nasdaq: CRWV) in March 2025. Learn more at the Role: The Staff, Energy Operations is a senior, development-facing role within CoreWeave's Data Center Development organization. This position is responsible for owning the site-level utilities path required to advance data center developments from early diligence through development readiness, construction alignment, and delivery to Operations — from dirt to blinky lights. This role owns the end-to-end execution of site-specific utility workflows, ensuring every project has a clear, validated, and de-risked path to capacity. The role operates hands-on with all utilities, developers, and internal teams to manage utility feasibility, delivery timelines, cost assumptions, and execution risk. You will work closely on utility execution, schedule, budget, local relationships, government affairs, and internal grid-planning teams, which remain responsible for policy, regulatory engagement, and long-range system planning. What You'll Do:Site-Level Utility Ownership (Hard Development Gate) • Own site-specific power feasibility and validation for all Development opportunities., • Serve as a hard Development gate — no site advances without a confirmed, executable utilities path., • Validate availability, delivery timelines, upgrade requirements, costs, and risk profiles.Utility Coordination & Execution, • Act as the primary site-level technical point of contact with utility providers., • Drive overall utility coordination, design reviews, infrastructure planning, development budgeting to turn over execution., • Hold utilities and external partners accountable to agreed delivery schedules and milestones., • Support on-the-ground engagement internal and external teams with utilities, municipalities, and local stakeholders.Alternative Power & Acceleration Strategies, • Support alternative power structures where required to accelerate delivery or mitigate risk., • Translate alternative power paths into a clear schedule, cost, and execution impacts for Development decision-making.Cross-Functional Integration, • Serve as the connective tissue across Development, Operations, Finance, Legal, Gov/Tax, Sustainability, Design, and Construction., • Ensure power costs, timelines, and risks are accurately reflected in:, • Development schedules, • TCO and financial models, • Executive-level materials supporting go / no-go decisionsConstruction & Operations Alignment, • Partner closely with Construction teams during Development and execution to:, • validate construction schedules and sequencing,, • Align power delivery milestones with build and commissioning plans,, • Roll up all utility-related outputs through the Principal of Development, who serves as the single point of contact by jurisdiction., • Maintain a single source of truth for:, • all site utility status,, • delivery timelines,, • risks and mitigations across the Development pipeline., • Prepare clear, executive-ready materials (presentations, summaries, risk readouts) for leadership review and decision-making.Contracting & Legal Support, • Partner with Legal to support negotiation and execution of: Utility Service Agreements, Interconnection Agreements, and Easements and site-specific power rightsDevelopment-Stage Technical Due Diligence, • Take evaluation package from power teams, translate to site-specific deliverables and schedule for all utility infrastructure post diligence., • Pressure-test assumptions to ensure Development schedules remain executable through construction and Ops handoff.Travel Requirements:, • Willingness and ability to travel regularly (25–40%), including:, • site visits and jurisdictional reviews,, • utility and municipal meetings,, • partner and developer coordination,, • collaboration with Design, Construction, and Operations teams., • Comfortable serving as the on-the-ground Development representative for ALL utilities.Who You Are:, • 10+ years of experience in power, utilities, or energy infrastructure supporting large-scale data center, industrial, or infrastructure developments., • Proven experience aligning utility infrastructure delivery with complex construction sequencing and master project schedules., • Demonstrated expertise in the full project development lifecycle, including early-stage supporting internal teams feasibility assessments, due diligence, and execution planning., • Extensive experience managing direct relationships and negotiations with U.S. utility providers, specifically regarding large-load (100MW+) interconnections across multiple jurisdictions., • Strong understanding of utility tariffs, interconnection processes, and site-level power cost modeling., • Extensive experience supporting the full construction lifecycle, from project inception through commissioning and transition to operational stabilization., • Direct experience in utility operations or a utility-facing execution role with a proven track record across national or multi-regional U.S. markets., • Technical familiarity with complex construction schedules, procurement of long-lead electrical equipment, and practical constructability assessments., • Demonstrated mastery of project management fundamentals, including the ability to mitigate risks and manage critical-path dependencies across multiple workstreams., • Experience developing high-level reporting, presentations, and strategic content to facilitate data-driven decision-making for executive leadership., • Professional exposure to Joint Venture (JV) frameworks or capital-partner development models within a real estate or infrastructure context. Wondering if you're a good fit? We believe in investing in our people and value candidates who can bring their diverse experiences to our teams – even if you aren't a 100% skill or experience match. Here are a few qualities we've found compatible with our team. If some of this describes you, we'd love to talk. • You love to translate complex utility and interconnection processes into executable development plans that keep projects moving., • You're curious about how power markets, grid constraints, regulatory shifts, and commercial structures shape site feasibility and long-term infrastructure strategy., • Be Curious at Your Core, • Act Like an Owner, • Empower Employees, • Deliver Best-in-Class Client Experiences The base salary range for this role is $161,000 to $215,000. The starting salary will be determined by job-related knowledge, skills, experience, and the market location. We strive for both market alignment and internal equity when determining compensation. In addition to base salary, our total rewards package includes a discretionary bonus, equity awards, and a comprehensive benefits program (all based on eligibility) What We Offer The range we've posted represents the typical compensation range for this role. To determine actual compensation, we review the market rate for each candidate which can include a variety of factors. These include qualifications, experience, interview performance, and location. In addition to a competitive salary, we offer a variety of benefits to support your needs, including: • Medical, dental, and vision insurance - 100% paid for by CoreWeave, • Company-paid Life Insurance, • Voluntary supplemental life insurance, • Short and long-term disability insurance, • Flexible Spending Account, • Health Savings Account, • Tuition Reimbursement, • Ability to Participate in Employee Stock Purchase Program (ESPP), • Mental Wellness Benefits through Spring Health, • Family-Forming support provided by Carrot, • Paid Parental Leave, • Flexible, full-service childcare support with Kinside, • 401(k) with a generous employer match, • Flexible PTO, • Catered lunch each day in our office and data center locations, • A casual work environment While we prioritize a hybrid work environment, remote work may be considered for candidates located more than 30 miles from an office, based on role requirements for specialized skill sets. New hires will be invited to attend onboarding at one of our hubs within their first month. Teams also gather quarterly to support collaboration. California Consumer Privacy Act - California applicants only CoreWeave is an equal opportunity employer, committed to fostering an inclusive and supportive workplace. All qualified applicants and candidates will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information. As part of this commitment and consistent with the Americans with Disabilities Act (ADA), CoreWeave will ensure that qualified applicants and candidates with disabilities are provided reasonable accommodations for the hiring process, unless such accommodation would cause an undue hardship. If reasonable accommodation is needed, please contact: . Export Control Compliance This position requires access to export controlled information. To conform to U.S. Government export regulations applicable to that information, applicant must either be (A) a U.S. person, defined as a (i) U.S. citizen or national, (ii) U.S. lawful permanent resident (green card holder), (iii) refugee under 8 U.S.C. § 1157, or (iv) asylee under 8 U.S.C. § 1158, (B) eligible to access the export controlled information without a required export authorization, or (C) eligible and reasonably likely to obtain the required export authorization from the applicable U.S. government agency. CoreWeave may, for legitimate business reasons, decline to pursue any export licensing process.

A mid-sized pharmaceutical company is seeking a Senior Vice President (SVP) of Regulatory Affairs in East Brunswick, New Jersey. This executive role will lead global regulatory strategy across CMC, Clinical, and Non-Clinical programs, and requires 15+ years of regulatory experience in pharma/biotech

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

We’re seeking an experienced SVP, Regulatory Affairs to lead all global regulatory strategy including CMC, Clinical, and Non‑Clinical approval pathways for a growing mid‑sized pharmaceutical company. Build, mentor, and scale a high‑performing Regulatory Affairs team; manage regulatory operat

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The Regional Executive Director ensures all aspects of clinical care and programming are aligned with evidence based, best practices, and complies with all applicable legal, ethical, and regulatory standards. Compliance with all applicable laws and regulatory standards. Knowledge of relevant legal,

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Owner of all CMC sections in global regulatory fillings. Lead CMC strategy and author drug substance and drug product sections for global regulatory filings for clinical trial and market authorization including IND, IMPD, NDA, and MAA. Author study development reports, process characterization repor

We are seeking a talented and experienced Construction Project Manager to oversee construction of a ground up MRI Facility.Come join our team! We are looking to build services and capabilities through the growth of our key asset- our staff.Ranked among the nation's top A/E firms by Engineering Ne

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A well-known and growing Personal Injury Law Firm in New Jersey is actively seeking an experienced full-time Bi-lingual Receptionist.Answer and manage a high-volume, 10-line phone system promptly.Route calls to appropriate staff members with accuracy.Greet visitors in a professional manner and maint

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Ensure projects adhere to industry standards, best practices, and regulatory compliance.

Substance Salon 52 Park Ave Rutherford, NJ.Substance Salon is seeking an experienced Operations Manager with a proven track record managing a salon, spa, or med spa and driving measurable sales growth.We are a 16 year established premium salon in Rutherford.This role is for a leader who understands

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This job description outlines the general nature and level of work performed by employees within this classification.It is not intended to be a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.Assist operations manager with a team

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

Flow-Turn has been a trusted global manufacturer of powered belt curves and specialty conveyors since 1981.Headquartered in Union, New Jersey, we specialize in designing and producing custom solutions tailored to meet diverse customer requirements.Serving industries such as baggage handling, packagi

Our client is looking for a Senior Project Manager to work at their manufacturing facility in Irvington, NJ.The Senior Project Manager is responsible for end-to-end execution of medium to high complexity Capital and Product Development projects.This person will lead cross functional project teams, a

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Job title : Project Manager – Banking & Capital Markets.Manage and lead assigned projects to completion with delivery of agreed objectives.Ensure that all projects follow Group Policies and Procedure – including proper Project Governance and reporting to senior management & stakeholders.

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Primary Responsibilities Include the Following:.Manage a portfolio of multiple innovations across Personal Care Categories that will accelerate the growth of the Suave business.Develop project timelines and identify milestones that support the planned in-store date.Oversee the product development jo