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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.

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.

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 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.

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 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.

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 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. 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. 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

Job Title : Regulatory Affairs Associate Location : Clark, NJ 07066 Duration : 12 Months Shift Details : On-Site Job Description : • Review formulas for compliance with local regulations, in particular for US and Canada, • Reviewing artwork for US and Canada Compliance, • Notifying products in US and Canada as needed, • Canada Chemical regulatory oversight and review, • Preparing registration documents as needed Qualifications: • Bachelors level degree in Science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs., • Experience in drug or cosmetic industry

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients.

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 DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US Advertising and Promotion – Eye Care combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual shares knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies. Responsibilities: • Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner., • Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers. Summarizes findings, under supervision, in concise reports for distribution within AbbVie., • Oversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act., • Develops and guides implementation strategies for promotional activities, • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas, • Ensures departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports (where applicable). Manages direct reports (where applicable) and assists in the development, training and mentoring of staff members., • Effectively presents pertinent information to appropriate cross-functional groups, • Effectively delivers difficult messages to commercial organizations without damage to relationships, • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) by fostering mutually beneficial interactions and exchange Qualifications • Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.), • Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.), • Experience working in a complex and matrix environment and exhibits strong negotiation skills, • Strong communication skills, both oral and written, • Experience in management capacity preferred, • Experience in US Regulatory Affairs Advertising and Promotion Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Purpose Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities • Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical Directors and/or Scientific Directors, and of Clinical Scientists working on the same or related programs., • Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB)., • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Qualifications • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a clinical research program of moderate complexity with minimal supervision., • Ability to perform and bring out the best in others on a cross-functional global team., • Ability to interact externally and internally to support a global scientific and business strategy., • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future., • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Purpose: Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities: • Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical Directors and/or Scientific Directors, and of Clinical Scientists working on the same or related programs., • Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB)., • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a clinical research program of moderate complexity with minimal supervision., • Ability to perform and bring out the best in others on a cross-functional global team., • Ability to interact externally and internally to support a global scientific and business strategy., • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description The Continuous Improvement Manager is responsible for leading, developing, and executing strategies to drive operational excellence across the medical device manufacturing organization. This role champions Lean, Six Sigma, and problem‑solving methodologies to improve product quality, reduce waste, enhance cost efficiency, and ensure regulatory compliance. The Continuous Improvement Manager partners closely with Manufacturing, Quality, Engineering, Supply Chain, and Regulatory Affairs to standardize processes and cultivate a culture of continuous improvement. Key Responsibilities Continuous Improvement Leadership • Develop and implement sitewide continuous improvement strategies aligned with business goals., • Facilitate Kaizen events, value stream mapping, root cause analysis (RCA), and other improvement workshops., • Mentor and train employees at all levels in CI tools, Lean thinking, and structured problem-solving., • Analyze production and quality performance to identify opportunities for efficiency, cost reduction, and throughput improvements., • Drive initiatives using DMAIC, PDCA, 5S, standard work, and other Lean/Six Sigma methodologies., • Ensure improvement projects support and strengthen compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements., • Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation., • Plan, execute, and sustain medium‑to‑large scale CI projects, ensuring milestones are met., • Develop business cases, project charters, and ROI analyses to justify improvement initiatives., • Promote a culture of operational excellence and accountability throughout the organization., • Create and maintain training materials, SOPs, and standardized processes., • Bachelor’s degree in Engineering, Manufacturing, Operations, or related field., • 5+ years of experience in continuous improvement, operational excellence, or process engineering within a regulated manufacturing environment (medical device preferred)., • Strong working knowledge of Lean, Six Sigma, and structured problem-solving tools., • Experience working within FDA-regulated or ISO 13485 environments., • Demonstrated success leading CI projects and cross-functional teams., • Excellent analytical, communication, facilitation, and change‑management skills., • Familiarity with statistical software (Minitab, JMP, etc.)., • Experience with automation, digital manufacturing tools, or Industry 4.0 technologies.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Candidates for this position can be located in either Florham Park, NJ or Mettawa, IL. The Associate Director, Migraine Consumer Marketing serves as the patient, brand and product subject matter expert for consumer marketing across the organization. They will work closely with multiple cross-functional teams and own external agency relationships to support key initiatives to drive brand success. Key Job Responsibilities • Lead evolution of brand consumer marketing strategy - including positioning, segmentation, omni channel strategy - to ensure continued alignment against objectives and long-term plan., • Develop data-driven insights, leveraging internal and external partners and diverse data sources to inform strategic planning and in-market execution, • Lead the development, execution and optimization of marketing tactics, including creative, media planning, and effectiveness metrics., • Collaborate with external agencies, internal partners, and leadership to build and execute marketing plans aligned to business goals., • Provide leadership, direction, and development for direct reports and foster positive working relationships while building a collaborative, integrated commercial brand team, • Partner with internal groups (e.g. Public Affairs, Legal, Regulatory, Medical and Project Management) to ensure compliance and consistency in approach and messaging., • Identify and implement new technological and operational capabilities in partnership with the internal Centers of Excellence (COE)., • Support the brand’s annual planning process, representing both DTC and cross-functional brand needs in development, alignment, and presentation to senior leadership.Qualifications, • Bachelor’s Degree required., • Proven marketing experience with increased proficiency in all marketing skills., • 8+ years of consumer marketing experience, prior Pharma and broadcast TV development. experience preferred, • Deep understanding of brand management principles, including positioning, personality & overall campaign development., • Proven experience developing and executing consumer marketing campaigns across all channels (i.e. TV, Digital, Social, Website, CRM)., • Track record of delivering impactful and timely in-market execution marketing campaigns, • Experience identifying key campaign metrics (KPIs) and utilizing for continuous enhancements and future design/innovation., • Experience managing multiple external agencies (advertising, media, digital, database) and internal partners., • Ability to influence at all levels in a highly matrixed organization, including senior management., • Strong planning and organization skills, attention to detail, execution, and follow-through. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients. Responsibilities • Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation)., • Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects., • Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately., • Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff., • Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures., • Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics department., • (Clin Stat) Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements., • (SSG) Lead statistical support for benefit-risk planning and assessment. Provide leadership to the development, delivery and interpretation of safety outputs, including graphics. Partner with cross-functional team to develop output specifications to address both pre-planned safety analyses and ad hoc requests., • evidence generation, including GMA studies, presentations, and publications in assigned therapeutic area(s). Support or lead GMA Statistics to provide functional area input for life-cycle management of products. Support or lead communications between assigned product team(s) and functional management. Build/drive cross-functional relationship and collaboration.Qualifications Minimum Qualifications: • MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field., • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams, • Pharmaceutical or related industry knowledge required (including experience and understanding of drug development and life-cycle management in the regulated environment.), • Experience leading safety-related projects (eg, ISS, benefit-risk assessment, signal detection), • High degree of technical competence and excellent communication skills, both oral and written, • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others, • Able to manage project timeline and quality of deliverables, • Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo Key Stakeholders Clinical development experts Statistical programmers Data science experts (SSG) Patient safety experts (GMA Stat) Global Medical Affairs experts Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities - • Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical Directors and/or Scientific Directors, and of Clinical Scientists working on the same or related programs., • Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB)., • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a clinical research program of moderate complexity with minimal supervision., • Ability to perform and bring out the best in others on a cross-functional global team., • Ability to interact externally and internally to support a global scientific and business strategy., • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Continuously expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. Proactively anticipates and mitigates regulatory risks. Ensures compliance with Global regulatory requirements. Manages compounds in the obesity TA through all phases of development, including post approval and through the life cycle of the product. Demonstrates excellent understanding of drug development in the obesity/metabolic TA and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of reg strategies. Responsibilities: • Interfaces with the LRST and AST to lead and support cross-functional company objectives. Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel., • Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests., • Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products., • Leads preparation of global regulatory product strategies for assigned products. Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders., • Acts independently under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT members. May have direct report(s) and contribute to the performance management for other RA team members, • Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products., • Follows company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements., • Ensures alignment of global regulatory strategies with Sr. Management. Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management. Proactively informs AST and cross functional management, including RDLT and Commercial Leadership of issues, labeling outcomes, approval or other risks and mitigations. Provides assessment of impact on global programs. Represents ABBV Regulatory position in interactions at Joint Governance., • Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects. Frequent to continuous computer usage (greater or equal to 50% of the workday) is required Qualifications • Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject., • Preferred Education: Relevant advance degree is preferred. Certification a plus., • Required Experience: 7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g. other R&D role or specialized training). Requires drug development experience in US&C region. Proven 5+ years in strategic leadership role with strong project management skills. Experience working in a complex and matrix environment with multiple stakeholders and influencing cross-functional teams. Experience interfacing with major government regulatory bodies., • Require experience cont’d: Strong communication and proactive negotiation skills. Experience development and implementing successful global regulatory strategies., • Preferred Experience: 10+ years experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global development foundation with business acumen., • Note: Higher education may compensate for years of experience. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. The Scientific / Medical Director, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities for AbbVie’s Oncology portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives, scientific communications, value propositioning, and safeguarding patient safety (risk minimization activities and safety surveillance activities). The Scientific / Medical Director works closely with commercial and research and development teams to provide critical medical input into evolving core medical, brand (product), and value and access strategies to support our evolving on-market and therapeutic area needs. Responsibilities • In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory, HEOR and other functional areas, provides leadership and support for assigned indications/projects., • Works closely with Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core asset strategy, and is responsible for executing medical support/launch activities for gynecologic oncology initiatives., • Conducts promotional review and assists in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia., • Serves as Medical expert for internal and external stakeholders regarding asset clinical profile, value, and appropriates; and provides Medical review for cross-functional deliverables, ensuring compliance and scientific accuracy., • Develops innovative research concepts, generates evidence, and drives execution of scientific communication plans, including high-quality publications, presentations, and educational programs., • Engages and cultivates relationships with key opinion leaders, scientific advisors, and advocacy groups within the gynecologic oncology community., • Monitors the evolving relevant therapeutic landscape to inform business decisions and anticipate future needs., • Leads the development and execution of advisory boards., • May lead delivery of medical functional plan, brand plan, and/or integrated evidence plan.Qualifications Position will be commensurate with education and experience. For Scientific Director: • Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred., • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred., • Substantial understanding of relevant therapeutic area required., • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred., • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Ability to run a clinical study independently with little supervision., • Proven strategic leadership, influencing, and collaboration skills in cross-functional environments. Ability to interact externally and internally to support global business strategy., • Expertise in evidence generation, scientific communication, and health economics/outcomes research., • Must possess excellent presentation, organizational, and written/oral communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. Purpose: Reporting to the Global Head of Neuroscience and Eye Care Pipeline, this role provides strategic medical and scientific leadership for core medical affairs activities in AbbVie’s Neurodegeneration Pipeline Portfolio. This includes healthcare provider engagement strategies, critical data generation, educational initiatives, and patient safety. Key to success is partnering closely with commercial teams to influence product strategies, support market access, and drive scientific communications. Offers medical insights and executes data generation, expert engagement, and communication initiatives across early and late-stage development. Leads gap assessments, develops scientific communication platforms and wholistic value narrative (including clinical, societal & humanistic), and guides integrated evidence plans to enable launch readiness. This position can be based from our Florham Park, NJ or Mettawa, IL sites and will follow a hybrid schedule of 3 days/week onsite. Responsibilities: • Lead, oversee, and support assigned indications and projects in collaboration with cross-functional teams (Medical, Clinical Development, Commercial, Market Access, HEOR)., • Initiate and manage medical affairs activities, data generation, and dissemination to advance scientific and business objectives., • Provide scientific and technical support for assets, deliver presentations, maintain relationships with key opinion leaders, and contribute to cross-functional teams., • Guide development of Target Product Profiles (TPP), contribute to Phase II-III trial design, and lead Phase 3b/4 strategies in alignment with TPP., • Lead the planning and execution of advisory boards, scientific, and medical education programs for both internal and external stakeholders., • Stay current on scientific advancements and literature; act as a resource for Psychiatry and other relevant therapeutic areas. Initiate and publish research projects., • Lead cross-functional teams on discrete projects such as data analysis, expert engagement, publications, and collaborations., • Represent Medical Affairs in due diligence activities for asset acquisitions aligned with disease area strategy., • Ensure scientific initiatives meet budget, timeline, and compliance requirements., • Manages a team of high performing colleagues.Qualifications, • Advanced degree (PhD/PharmD/DVM); post-doctoral experience preferred., • Senior Director: Advanced degree with minimum 10 years’ experience in clinical trials or medical affairs (pharmaceutical industry or academia); typically 15 years overall experience., • Executive Medical Director: M.D. with minimum 5 years of clinical trial experience. 7+ years preferred., • Strong leadership and cross-functional team management skills in a global environment., • Expertise in a relevant therapeutic area with ability to provide scientific strategy and support., • Proven ability to independently lead clinical studies or medical affairs teams., • Knowledge of clinical trial methodology, regulatory requirements, and protocol design., • Excellent oral and written communication skills in English., • People management experience preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future., • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. Purpose: Reporting to the Global Head of Neuroscience and Eye Care Pipeline, this role provides strategic medical and scientific leadership for core medical affairs activities in AbbVie’s Psychiatry Pipeline Portfolio. This includes healthcare provider engagement strategies, critical data generation, educational initiatives, and patient safety. Key to success is partnering closely with commercial teams to influence product strategies, support market access, and drive scientific communications. Offers medical insights and executes data generation, expert engagement, and communication initiatives across early and late-stage development. Leads gap assessments, develops scientific communication platforms and wholistic value narrative (including clinical, societal & humanistic), and guides integrated evidence plans to enable launch readiness. This position can be based from our Florham Park, NJ or Mettawa, IL sites and will follow a hybrid schedule of 3 days/week onsite. Responsibilities: • Lead, oversee, and support assigned indications and projects in collaboration with cross-functional teams (Medical, Clinical Development, Commercial, Market Access, HEOR)., • Initiate and manage medical affairs activities, data generation, and dissemination to advance scientific and business objectives., • Provide scientific and technical support for assets, deliver presentations, maintain relationships with key opinion leaders, and contribute to cross-functional teams., • Guide development of Target Product Profiles (TPP), contribute to Phase II-III trial design, and lead Phase 3b/4 strategies in alignment with TPP., • Lead the planning and execution of advisory boards, scientific, and medical education programs for both internal and external stakeholders., • Stay current on scientific advancements and literature; act as a resource for Psychiatry and other relevant therapeutic areas. Initiate and publish research projects., • Lead cross-functional teams on discrete projects such as data analysis, expert engagement, publications, and collaborations., • Represent Medical Affairs in due diligence activities for asset acquisitions aligned with disease area strategy., • Ensure scientific initiatives meet budget, timeline, and compliance requirements., • Manages a team of high performing colleagues.Qualifications, • Advanced degree (PhD/PharmD/DVM) required; post-doctoral experience preferred., • Senior Director: Advanced degree with minimum 10 years’ experience in clinical trials or medical affairs (pharmaceutical industry or academia); typically 15 years overall experience., • Executive Medical Director: M.D. with minimum 5 years of clinical trial experience. 7+ years preferred., • Strong leadership and cross-functional team management skills in a global environment., • Expertise in a relevant therapeutic area with ability to provide scientific strategy and support., • Proven ability to independently lead clinical studies or medical affairs teams., • Knowledge of clinical trial methodology, regulatory requirements, and protocol design., • Excellent oral and written communication skills in English., • People management experience preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities: • Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives., • Maintains and evaluates productivity metrics to project current and future business needs, • Aligns and maintains effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identifies areas of improvement in process/policy, develops recommendations/plan, and leads initiatives., • Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs., • Operates independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day-to-day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers., • Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development., • Exhibits solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possesses and leverages broad industry knowledge, • Develops and implements complex processes and projects and develops and delivers strategic presentations for senior management, • Identifies areas of improvement in process, policy, develops recommendations/plan and leads initiatives, • Bachelor’s degree plus 8+ years of relevant experience (e.g. Applicable pharmaceutical/medical devices/biologics experience, pharmacy rotations Public Health, etc.), • Advanced degree preferred: MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD degree plus 6 years of relevant industry experience. Certification a plus., • Experience in US Regulatory Affairs Advertising and Promotion highly preferred, • Experience working in a complex and matrix environment, • Strong communication skills, both oral and written, • Experience developing and implementing successful global regulatory strategies, • Experience in management capacity preferred Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately paymore or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and untilpaid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities: • Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives., • Maintains and evaluates productivity metrics to project current and future business needs, • Aligns and maintains effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identifies areas of improvement in process/policy, develops recommendations/plan, and leads initiatives., • Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs., • Operates independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day-to-day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers., • Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development., • Exhibits solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possesses and leverages broad industry knowledge, • Develops and implements complex processes and projects and develops and delivers strategic presentations for senior management, • Identifies areas of improvement in process, policy, develops recommendations/plan and leads initiatives, • Bachelor’s degree plus 8+ years of relevant experience (e.g. Applicable pharmaceutical/medical devices/biologics experience, pharmacy rotations Public Health, etc.), • Advanced degree preferred: MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD degree plus 6 years of relevant industry experience. Certification a plus., • Experience in US Regulatory Affairs Advertising and Promotion highly preferred, • Experience working in a complex and matrix environment, • Strong communication skills, both oral and written, • Experience developing and implementing successful global regulatory strategies, • Experience in management capacity preferred Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description This role may be based in either Florham Park, NJ, or Lake County, IL. The Associate Director (AD) of HCP Promotion reports to the HCP Marketing Director. The AD is the primary owner of GenAIsys development, incorporating provider pathway and specialty insights to support omnichannel integration. They lead the evolution of generic strategy, specialty-segmented strategy execution, and KPI tracking. The AD is also responsible for HCP unbranded content, including challenger insights. This role works closely with cross-functional teams including MABI, medical affairs, market access, training, finance, compliance, and others to develop, analyze, refine, and deploy the HCP promotional strategy. As a prominent member of the Marketing Team, the AD is expected to bring significant experience in product management, sales force execution, customer analytics, and innovative problem-solving to the team. A track record of success in working with cross-functional teams is important to the role. The AD must demonstrate a strong competency in communication and quantitative analysis skills to generate the support for their strategic plans with the Integrated Brand Team and Sales Leadership Teams. • Lead the development, analysis, refinement, and deployment of the HCP promotional strategy, • Development of HCP messaging by targeted customer segments leveraging market insights and clinical data, • Manage a significant HCP promotional budget supporting personal and non-personal promotion to HCP customers, • Work in close partnership with the sales teams to implement HCP promotional messages at POA meetings and throughout the year, • Develop robust working relationships with key customers (both internal and external) through exceptional communication and partnership practices, • Work collaboratively with HCP brand team and Integrated Brand Team across all approved indications, • Drive the development of the annual strategic and tactical plans, working in concert with the consumer, market access, and medical affairs teams for presentation to the leadership, • Collaborate and communicate with multiple agencies and external vendors to plan for, prioritize, and execute brand tactics within timelines and allocated budget, • Gain approval for marketing materials through internal review processes to ensure marketing activities are in compliance with medical, regulatory and legal requirements., • Define key performance metrics & assess brand performance, • Maintain detailed understanding of disease and competitive marketplace, • Develop and deliver presentations to key internal stakeholders (Psychiatry Integrated Brand Team, Neuroscience business unit, leadership team, sales teams) and external audiences, • Bring innovative thinking and ideas to the table, challenging the status quo where appropriate to ensure brand and portfolio market leadership, • Operate in compliance with all AbbVie internal policies (ethics, environmental health and safety, financial, human resources, and general business policies) and applicable external regulatory requirements.Qualifications, • Bachelor’s Degree required., • Proven marketing experience with increased proficiency in all marketing skills., • At least 7 years of pharmaceutical experience with strong analytical and strategic marketing skills is required, • Previous experience in product management, specifically in the US market for HCP personal and non-personal promotion is strongly preferred, • Strong communication skills, both oral and written, with the ability to make effective presentations to internal and external customers, sales teams, and senior management, • Sound financial acumen with a foundational understanding of P&L drivers and previous experience with budget ownership is required, • Ability to define, track, analyze key performance measures and make data-driven decisions, • Strong interpersonal skills with ability to lead, interact with focus, and drive consensus among internal and external stakeholders from a variety of backgrounds, disciplines, and departments, • Proven project management skills, tactical development, planning, and execution, and prioritization among competing business needs, • Is a self-starter, intellectually curious, and can change course rapidly where required, • Is open to suggestions and experimentation for improvement, embraces ideas from others, encourages innovation but is grounded in reality, • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of marketing materials, • Willingness to travel up to 25%, attending sales meetings, field visits, conferences, market research, meetings with key stakeholders, • A potential pharmaceutical leader who is Excellence Focused; Optimistic; Open and Authentic Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description Join The WorkPlace Group’s Pharmaceutical Talent Pool! Are you a passionate professional in the pharmaceutical industry looking for your next career opportunity? The WorkPlace Group is excited to invite you to join our exclusive candidate talent pool! Why Join Us? • Exclusive Opportunities: As a Leading Recruitment Process Outsourcing (RPO) and Executive Search provider, we know about job openings before they become public. We also have direct access to the Company’s Hiring Managers and serve as their exclusive and in-house recruiter., • Priority Consideration: When a job needs to be filled, our recruiting teams first look for candidates in our database and candidate network. By sharing and uploading your resume, you can gain access to a wide range of job openings in leading pharmaceutical companies., • Pharmaceutical Professionals: Whether you’re in research, development, manufacturing, quality control, regulatory affairs, or sales, we want to hear from you!, • Common Job Titles: We frequently fill positions such as Research Scientist, Clinical Research Associate, Quality Assurance Specialist, Regulatory Affairs Manager, Pharmaceutical Sales Representative, and more. Visit our website to see a complete list of job titles., • Experienced and Entry-Level Candidates: We welcome candidates at all stages of their careers., • Upload Your Resume, • Stay Connected and follow us on LinkedIn, Instagram and X For more information, visit our website at

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Candidates for this position can be located in either Florham Park, NJ or Mettawa, IL. Talent will be hired at a level commensurate with experience. Seeking a collaborative, driven Marketing Manager I/II to drive strategic launches and brand growth for Oral Migraine. This role will focus on execution and planning for new indications and expansion, with a strong emphasis on HCP with demonstrated proficiency with brand planning processes and DTC. The successful candidate will coordinate cross-functional teams, leverage market insights, and ensure launch readiness for multiple Oral Migraine indications. Key Responsibilities: • Lead the execution of innovative launch and go-to-market strategies., • Develop and implement HCP tactics and messaging aligned with the journey and needs across diverse stakeholders; support in the development of DTC tactics., • Utilize the brand planning and launch readiness process to drive impactful brand plans and ensure alignment with business and franchise priorities., • Collaborate cross-functionally with Sales, Medical Affairs, Market Research, Regulatory, Training, Operations, and Agency/External Partners., • Analyze market dynamics and stakeholder feedback to inform decisions, identify opportunities, and recommend strategic/tactical shifts., • Support and coordinate the execution of field/sales force initiatives and communication for launches and inline growth., • Manage multiple projects/workstreams with a strong focus on execution, organization, and detail., • Track and manage area marketing budgets and campaign effectiveness to ensure efficient resource utilization., • Foster a culture of innovation, positive teamwork, and continuous improvement within the launch team., • Stay current with pharmaceutical and migraine market trends to ensure market-advantaged positioning. Qualifications, • Bachelor's Degree, • 5+ years of broad marketing experience in pharmaceutical brand (HCP and/or DTC), with demonstrated experience in brand launch, brand planning, and cross-functional management., • Strong understanding of HCP and DTC channels, including messaging, tactics, and measurement., • Experience managing multi-functional projects, budgets, and timelines in a fast-paced environment., • Excellent communication (oral, written, and presentation) and interpersonal skills., • Proven ability to work collaboratively, drive results, and influence others without direct authority., • Knowledge of pharmaceutical regulations and standards. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Purpose Manages other Medical and/or Scientific Directors and leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Responsibilities Personally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel. • Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols assigned., • Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents., • Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals., • May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs)., • Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a complex clinical research program independently., • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence., • Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy., • Ability to interact externally and internally to support a global scientific and business strategy., • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills, • Ability to exercise judgment and address complex problems and create solutions across multiple projects. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. The Scientific Director, Global Oncology Pipeline, Medical Affairs provides specialist medical and scientific strategic and operational input into core pipeline medical affairs activities such as: disease area and asset strategy, evidence generation, early value propositions, narratives and publication strategy. Works closely with asset strategy, pipeline commercialization, clinical development, area and affiliate teams to ensure pipeline asset launch success. This specific position will focus on the gynecologic oncology pipeline portfolio. This position is ideally based at our Mettawa, IL or Florham Park, NJ locations and will follow a hybrid schedule of Tuesdays-Thursdays in office. Other AbbVie sites may be considered, also following a hybrid schedule. Responsibilities: • Leads medical input into disease area strategy and asset strategies within the gynecologic oncology pipeline portfolio., • Leads pipeline medical evidence generation strategy and execution including company sponsored studies, research collaborations and investigator initiated studies., • Provides in-house medical expertise for the disease area and assets, coordinating appropriate scientific activities with internal and external stakeholders as they relate to ongoing programs. May participate in due diligence or other business development activity as required by program needs, and contribute to translational strategy in partnership with discovery colleagues., • Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate., • Leads creation of early scientific narratives, messaging, and communications activities including congress planning, medical education, publication strategies and plans., • Ensures budgets, timelines, compliance requirements are factored into programs and scientific activities.Qualifications, • Advanced Degree MD, PhD or PharmD. Additional post doctorate experience highly preferred., • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred., • Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of gynecologic oncology required., • Minimum of 4 years of clinical trials experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred., • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Proven leadership skills in a cross-functional global team environment., • Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately paymore or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and untilpaid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director of IRA Navigation and Possibilities is business-critical role at AbbVie, created in response to the significant impact of the Inflation Reduction Act (IRA) on the pharmaceutical industry. This director will act as a subject matter expert, providing strategic direction and cross-functional leadership to help AbbVie proactively manage IRA-related risks and opportunities for both current commercial brands and future pipeline products. Key Responsibilities: • Partner closely with Commercial Therapeutics, US Market Access, Global Commercial Development (GCD), Finance, Government Affairs, and Legal to understand and dissect IRA’s potential effects on individual brands and pipeline assets., • Be the subject matter expert for therapeutic area leaders, Integrated Brand Teams (IBTs), and Asset Strategy Teams (ASTs) on the implications and timelines of IRA implementation and its long-term impact, raising organizational acumen and preparedness., • Develop and lead a structured framework for the ongoing evaluation and risk assessment of on-market and pipeline assets, collaborating with IBTs and ASTs., • Identify and prioritize risks posed by the IRA over the Long Range Plan (LRP) for each asset and facilitate cross-functional risk-navigating teams to propose and drive effective mitigation strategies, including life cycle management, negotiation alternatives, and evidence generation., • Contribute to portfolio-wide risk stratification and segmentation, enabling AbbVie to focus resources and innovation on areas of greatest need and potential impact., • Support organizational innovation by driving solutions that minimize IRA risk and maximize opportunity for patients, AbbVie, and the broader industry.Qualifications, • Bachelor's degree in business or related discipline., • Master’s degree highly desirable to ensure ability to consult on business strategy development and analyze information to build insights., • Advanced degree in life sciences, business, public policy, or related field preferred., • Extensive experience in the pharmaceutical industry, ideally in portfolio risk management, market access, or strategic planning roles., • Deep understanding of the US healthcare policy and regulatory landscape; specific knowledge of the IRA is highly valued., • Strong leadership skills with proven ability to drive cross-functional teams and lead complex projects., • Exceptional communication, negotiation, and interpersonal abilities., • Demonstrated analytical thinking and problem-solving skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future., • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Leads the Gastroenterology team in developing and executing the Medical Affairs strategy for Upadacitinib. Responsible for practical and clinically meaningful data strategy and delivery to inform clinical use and transform standard of care. Aligning all internal parties on Medical Benefit-Risk Evidence based positions. Deeply understanding the patient journey and apply insights into determining the medical need. Expected to work closely with Clinical Development and Asset Teams to ensure that global customer insights and health care practices, current and future are incorporated in the clinical development and regulatory plans. Provide strategic medical input into core brand strategies, and to support medical marketing activities and market access. Responsibilities: -Actively participates in advancing and communicating corporate and GMA philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of TA management. May assist in developing/mentoring junior medical affairs staff. -Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies. -Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities. -All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. -Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. -Oversees scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information. -May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities. Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area. May represent the medical function on cross-functional integrated teams for medical affairs activities. -Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. -Drives Medical Affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. -Accountable for the medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides strategic guidance to cross-functional team members related to the medical content. Maintains oversight of TA specific medical content included in commercial communications. . Qualifications • Advanced degree (MD, PhD, DO) with relevant therapeutic specialty in an academic or hospital environment highly preferred. Relevant therapeutic area clinical experience and/or Medical Affairs in an academic, hospital or pharma environment required., • Typically 8 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent., • Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a complex medical affairs team(s) independently., • Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Expert knowledge in a relevant therapeutic specialty. Must have basic understanding of Pharmacovigilance practices for Clinical Development programs., • Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives., • Works independently and leads team., • Can address complex problems within discipline or across several projects., • Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions., • Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future., • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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.

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