• Function as a Subject Matter Expert (SME): to nutrition and clinical science expertise to translate complex science and research into compelling product claims and scientific messaging. • Communicate the science and product benefits to both internal and external audiences of varying knowledge levels. • Remain current in standards of nutrition care and scientific literature. • Represent Nutrition Science in cross-functional initiatives and programs. • Product claims development and substantiation. • Establish and maintain internal stakeholder relationships (e.g., medical affairs, platform scientists, product development, commercial, public affairs, regulatory), and external stakeholders (e.g., key opinion leaders, customers and consumers). • Actively engage in product ideation and innovation to build product pipeline. • Assess new ingredients and technologies. • Develop clinical research strategy that generates new evidence for new claims, messaging, and publications. • Prepare and deliver nutrition science-based content and presentations to field sales force, sales training, affiliates, advisory boards, customers, consumers and external key opinion leaders. • Develop and review AN product and science educational materials.

Title: Spanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - Indianapolis Location: - Schererville, Indiana, United States - Indianapolis, Indiana, United States - Avon, Indiana, United States - Batesville, Indiana, United States - Bloomington, Indiana, United States Part-time Remote Job Type: Per Diem Job Description: Job Title: Registered Dietician - Indianapolis IQVIA are looking for experienced Dieticians to join our team. The ideal candidate will have experience in providing dietary advice and support to individuals with rare diseases. Key Responsibilities: Our remote Registered Dieticians are responsible for: - Conduct nutritional assessments and develop personalized dietetic plans for clients with various disease classifications via telecommunications. - Provide ongoing dietetic counselling and support to clients and their families - Nutritional assessments and dietetic counseling (only done for clients in which you are licensed to practice.) - Maintain accurate and confidential client records - Participate in virtual team meetings and training sessions Qualifications: - Qualified Registered Dietician (CDR) with Current National Registration and in-state licensure (except CA, MI, NJ, AZ, VA, and CO) - In-state licensure: Unencumbered and active state license required - Multi-state license in NY, FL, and TX preferred - Minimum 1 year of experience planning for and coaching patients - Minimum 1 year of experience working remotely via telehealth - Excellent communication and interpersonal skills - Experience working with patients with obesity (with and without diabetes) preferred - Experience managing patients on GLP-1 preferred - Bilingual (Spanish/English) required Note: This position is not eligible for sponsorship. #remote IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role is $45 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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 Senior Specialist Drug Safety Submission, also known as Pharmacovigilance (PV) Submission Specialist, will focus on ensuring the timely and accurate submission of global safety reports to regulatory authorities and investigators, ensuring drug safety and compliance. This role will also support the PV safety systems programming and maintenance and provide review and expertise for global Safety management plans and other PV study documents to ensure regulatory reporting accuracy. Essential Functions - Prepare and submit safety reports (e.g., Individual Case Safety Reports, Periodic Safety Update Reports and Development Safety Update Reports) to Global regulatory agencies. - Ensure that all submissions adhere to relevant global regulations and guidelines. - Contribute to the development and improvement of global safety reporting processes. - Support the department with EudraVigilance registration issues and maintenance of EudraVigilance accounts. - Manage and maintain safety data, ensuring accuracy and completeness. - Collaborate with cross-functional teams to gather and share safety information. - Participate in audits and inspections related to safety reporting. - Support programming efforts in relation to PV safety systems for regulatory reporting. - Assist with clinical study project set-up/close-out regarding regulatory reporting. - Represent PVG in ImmunityBio internal and external team meetings. - Resolve complex problems through in-depth evaluation of various factors and collaboration with stakeholders. - Maintain up-to-date knowledge of required therapeutic areas and regulatory requirements for SAE processing. - Assist in the generation and writing of DSURs and other periodic reporting. - Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. - Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities. Education & Experience - RN, pharmacist, or Bachelor’s degree in Health Sciences or health science field, with 5+ years of drug safety surveillance and/or pharmacovigilance or comparable relevant experience and training is required OR; - Associate’s degree with 7+ years of drug safety surveillance and/or pharmacovigilance experience or comparable relevant experience and training is required. - Experience in drug safety, pharmacovigilance and global regulatory reporting is required. - Experience in using safety databases and reporting systems is required. - Experience with safety database programming is required. (with ARISg a plus) - Medical writing experience with PSURs, DSURs, SDEAs is preferred. - Oncology experience is preferred Knowledge, Skills, & Abilities - Strong understanding of pharmacovigilance principles, global regulatory requirements and safety reporting guidelines. - Expert global knowledge of GCPs and regulatory requirements. - Ability to coordinate complex global and domestic studies. - Knowledge of international safety reporting processing. - Effective problem-solving ability and project management skills. - Effective mentoring skills and ability to train and lead others. - Knowledge of Broad-based therapeutics - Excellent oral, written communication skills and attention to detail. - Ability to work within a team and independently as needed - Excellent analytical and technical skills, including the ability to comprehend and integrate scientific data from a variety of sources. - Proficiency with medical terminology. Working Environment / Physical Environment - This position works onsite or remote based on the candidate’s geographic location. - 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 20 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. National Market (all markets unless identified as Premium) $118,500 (entry-level qualifications) to $130,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $135,000 (entry-level qualifications) to $148,500 (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.

CRA II - Sponsor Dedicated | Oncology / Neurology (Home-Based - Orlando, FL) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $70,100.00 - $126,100.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.