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Job Description Founded in 2009, EDETEK is a global leader in clinical technology and services, delivering high-quality, AI-powered platforms and solutions to pharmaceutical, biotechnology, and medical device companies. With a presence across four continents and a client base of over 100 biopharmaceutical companies, EDETEK is transforming clinical development through cloud-native technologies, intelligent data management, and automation. Our platforms are built for scalability, interoperability, and compliance. The Director of AI will lead the development and implementation of AI strategies to enhance clinical development processes. This role is responsible for architecting scalable AI solutions, guiding technical execution, and driving innovation across EDETEK’s AI product portfolio. The ideal candidate will have deep expertise in AI and clinical development for life sciences companies, with a strong background in machine learning, data science, and enterprise AI systems. This role requires a dynamic leader who thrives in a fast-paced, startup-like environment and can translate business goals into impactful AI solutions. Essential Functions and Responsibilities 1. AI Strategy & Leadership • Define and execute the AI vision aligned with EDETEK’s strategic goals., • Lead cross-functional teams to deliver AI-driven capabilities across clinical development., • Provide technical leadership and mentorship across the AI engineering team., • Inform and deliver on ambitious product roadmaps to accelerate growth. 1. AI Architecture & Development • Architect and build scalable AI infrastructure and solutions to support business growth., • Oversee model training, optimization, and deployment of end-to-end ML models., • Define best practices for AI/ML lifecycle management and governance., • Ensure compliance with industry standards and regulatory frameworks. 1. Collaboration & Stakeholder Engagement • Collaborate with stakeholders to translate business goals into technical solutions., • Partner with engineering, product, and clinical teams to integrate AI into platform capabilities., • Communicate AI strategy and progress to executive leadership and external partners. 1. Innovation & Technical Execution • Lead initiatives in advanced AI domains including transfer learning, generative models, and reinforcement learning., • Drive the development of enterprise knowledge management systems, NLP frameworks, and semantic data integration., • Implement reasoning methodologies including formal logic inference, graph analytics, and machine learning discovery techniques. Requirements • Master’s degree in Engineering, Computer Science, or a related quantitative field; advanced degree preferred., • 6+ years of hands-on experience in clinical trials and clinical development., • 3+ years of experience building and deploying AI/ML solutions and products., • Strong background in AI/ML fundamentals and software development., • Experience with modern databases, cloud environments, and data ecosystems., • Proven success in leading large-scale projects with multiple stakeholders., • Ability to thrive in a startup-mode environment and manage change effectively., • Excellent communication and interpersonal skills. Preferred Qualifications, • Expertise in transfer learning, unsupervised feature generation, meta-learning, generative text models, reinforcement learning, and Agentic AI., • Proficient in deep programming and production-grade AI implementation., • Experience designing enterprise knowledge systems, semantic web frameworks (RDF, OWL, SPARQL), and healthcare classification systems (SNOMED CT, CDISC, MeSH)., • Advanced data science and mathematical skills (e.g., PhD in computational modeling, machine learning, statistics, computer science). Why Join EDETEK?, • Opportunity to lead and innovate in a dynamic and growing company., • Collaborative and inclusive work environment., • Competitive salary and benefits package., • Make a significant impact on the future of clinical development through AI. Benefits Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees. • Choice of comprehensive Medical, Vision and Dental Insurance plans, • Paid vacation time and sick days, • Corporate holidays annually, • Participation in the 401K Plan, • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc., • Health Advocate and Employee Assistance ProgramLocation NJ with onsite or hybrid work arrangements. Candidates should be able to be in the area up to 50% of the time. Equal Opportunity Employer Statement EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.

The Director/Senior Director, Product Safety and Pharmacovigilance is a highly scientific and mid-level leadership role that requires medical and safety expertise as the Product Safety and Pharmacovigilance representative on the product clinical development team. In addition, he/she manages and conducts ongoing safety surveillance for assigned products. Also, oversees the preparation of NDA safety updates, IND safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary. Additionally, he/she collaborates with cross-functional groups and other regional safety counterparts to update them on medical assessment, safety signal detection, and risk management practices in the US and international markets. The candidate will have broad knowledge and perspective of drug safety in pharmaceutical/biotech industry and clear understanding of safety reporting requirements and experience in global regulatory environment and processes. MAJOR RESPONSIBILITIES • Provide medical and safety expertise as the Medical Safety and Pharmacovigilance representative on the product clinical development team., • Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents (including IND and NDA)., • Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents including Investigators Brochures, clinical trial protocols, informed consent forms, safety management plans, clinical study reports, integrated safety summary and summary of clinical safety., • Manages and conducts ongoing safety surveillance on assigned products. Oversees the preparation of NDA safety updates, IND safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary., • Co-organize, prepare and conduct safety management team meetings for assigned products and responsible for safety surveillance, signal detection and risk management., • Coordinates the new development or maintenance of internal SOPs/WIs to ensure the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements., • Applies general safety signal management methodologies and product specific signaling strategies to monitor for emerging issues related to assigned products., • Ensure that the safety profiles of assigned HMP products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required., • Perform medical review of individual case safety reports (ICSRs) for assigned products., • Collaborate with cross-functional groups and other regional counterparts to update them on medical assessment, signal detection and safety risk management practices in the US and international markets, • Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data., • Assist in the creation, review and implementation of SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk minimization. QUALIFICATIONS • Physician (MD, DO, or equivalent) or PharmD, or PhD in Nursing/Pharmacy with minimum 6-10 years related experience in clinical safety and pharmacovigilance., • Experience in the oncology therapeutic area is preferred., • Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and global safety regulations are highly preferred., • Experienced in global regulatory environment and processes (US, UK, EU, AU, JP), and the ability to integrate safety medical knowledge with regulatory and commercial input., • Ability to critically evaluate safety data from multiple sources (clinical trials, animal studies, post-market environment, literature, etc), assess clinical importance, benefit risk and potential strategic impact of the data and present the findings clearly in both written and oral communications., • Experienced in writing/review of aggregate safety documents (DSUR, PSUR, and PBRER etc.) and risk management plans., • Thorough understanding of US and European pharmacovigilance regulations, GCP and ICH guidelines., • Demonstrated knowledge of biostatistics and epidemiology are preferred., • Good ability to interpret complex clinical data and experimental results., • Working knowledge of validated drug safety database (preferably ARGUS) and MedDRA., • Ability to influence, negotiate and communicate with both internal and external stakeholders., • Excellent English (writing and speaking) and excellent mastery of English medical terminology.

Job Description Summary The Medical Science Liaison (MSL) is a field based, customer-facing, non-promotional medical and scientific role. Their key objective is to create impact through advancing clinical practice within the territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the strategic impact of critical insights. Job Description Key Responsibilities: The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy • The primary responsibility of the MSL is to engage with customers - customer engagements may include but not be limited to emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle., • Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence in disease space throughout the product development journey to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate • Provide clinical trial support for company sponsored trials and facilitating relevant medical activities, including but not limited to identification of appropriate sites, supporting clinical trials (subject recruitment, protocol questions, SIVs, etc.) at sites, and cross-functional collaboration with Medical Affairs and Clinical Operations colleagues, • Regularly collaborate with internal colleagues (e.g., HEOR, access, marketing, commercial) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards, • Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues, • Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect the day-to-day, • Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM, • Champion emerging responsibilities as strategic priorities and territory needs evolve, • Proactively drive personal and professional development, • Conduct yourself with the highest ethical standards and adhere to Novartis Code of Conduct. Comply with all relevant laws and regulations and Novartis Ethics, Risk & Compliance policies, and procedures. Essential Requirements: • Education:Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc.), • Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required., • Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required., • Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies., • Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around them do the same., • Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment., • Adherence with Company policies, state and federal laws and regulations, • Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. Desirable Requirements: • Previous experience in assigned or related therapeutic area is preferred. NOTE: Above level experience criteria are not an exhaustive list. Driving is an Essential Function of this Role:Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. The salary for this position is expected to range between $160,300.00 and $297,700.00 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. 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 us.reasonableaccommodations@novartis.com 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 $160,300.00 - $297,700.00 Skills Desired Building Constructions, Business Analysis, Business Networking, Clinical Protocols, Clinical Research, Clinical Study Reports, Communication, Curious Mindset, Disease Management, Diversity and Inclusion (D&I), Drug Development, Epidemiology, Medical Information, Medical Research, Medical Writing, Microsoft Word, Phase Iv Clinical Trial, Product Placement, Scientific Support

Job Description Summary LOCATION: Homeworking UK or Ireland or Hybrid Working at Westworks London or Dublin: Please apply only if any of these locations are accessible to you, as relocation support is not available. ROLE TYPE: Homeworking, #LI-Home or Hybrid working, #LI-Hybrid As a core member of the Clinical Trial Team (CTT), the main purpose of this position is accountability for vendor service delivery at the study level to independently manage all clinical vendor related aspects of global clinical trial(s). Job Description Key Responsibilities: Collaborate closely with study team lead and members throughout the study lifecycle. Review vendor-related protocol sections during protocol development. Manage vendor interfaces and support contract negotiations in collaboration with procurement. Oversee vendor cost control, budget reviews, invoice reconciliation, and PO close-out. Ensure vendor service excellence, maintaining quality and service standards at the study level. Drive site activation, compile central documents, and address risks/issues during site activation. Conduct user-acceptance testing (UAT) for eCOA and IRT systems. Monitor vendor-related cycle times and risks using tools like FIRST, while implementing corrective actions as needed. Essential Requirements: • 5+ years of experience with clinical operations and vendor management processes. Strong understanding of GxP and ICH regulations. Solid knowledge of clinical trial design and alignment to supplier requirements. Experience conducting User Acceptance Testing (UAT) for eCOA and IRT systems. Proven expertise in vendor management, including outsourcing, contracting, and sourcing clinical services. Results-oriented, with a track record of completing projects on time. Ability to collaborate effectively in cross-functional teams within a matrixed environment. Strong influencing, negotiation, communication, and problem-solving skills. 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. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Skills Desired Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model

Job Description Summary Onsite #LI-Onsite East Hanover, New Jersey About the role: The Statistical Programming community at Novartis comprises of approximately 350 (internal) statistical programmers and part of the Advanced Quantitative Sciences (AQS) organization which also includes more than 450 biostatisticians, pharmacometricians and data scientists supporting the entire portfolio of clinical projects across the Research, Development and Commercial spectrum In this role, you will be responsible for all statistical programming aspects of one or more drug development programs or indication programs. This role may involve being a people manager, a program lead, or both. You will lead cross-functional collaboration within and outside AQS and decision-making for assigned trials/programs in drug life cycle management and efficient, timely execution of integrated/clinical development/evidence plans. You will also take on strategic technical roles across programs or at an enterprise level. This includes, but is not limited to, consulting on pooling strategies, acting as a subject matter expert (SME) at audits/inspections, and leading technical non-clinical initiatives. You will engage with and influence industry working groups and organizations. Job Description Your Key Responsibilities: Lead statistical programming activities for multiple clinical trials within a program or an indication /disease area, or development program. Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Coordinate activities of internal / external programmers. Make statistical programming decisions and propose strategies at program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s). Responsible for allocating resources within a program and ensuring resource sharing between programs to meet AQS and organizational goals. May act as an operational and/or functional manager of associates including providing supervision and guidance to these programmers on operational / functional expertise and processes. Recruit, mentor, and develop statistical programmers. Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan). Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training. Represent statistical programming at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC). Offer expert technical and professional recommendations, thought leadership for the SP function at the indication/ program level or for non-clinical initiatives. Video Link _ This position will be located at the East Hanover, New Jersey site and will not have the ability to be located remotely. Role Requirements: Essential Requirements: BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 6+ years in a programming or statistical role. 3+ years experience in a line management or equivalent leadership experience, such as matrix management (applicable for people managers only). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met. In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP) Expert in SAS or R programming, including the development and validation of deliverables within a Statistical Programming environment, and the creation of advanced MACROs and/or functions. Significant experience in contributing to statistical analysis plans and developing technical programming specifications. Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs. At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers. Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders. Desired Requirements: 10+ years experience in a programming or statistical role equivalent Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $145,600 and $270,400 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. To learn more about the culture, rewards and benefits we offer our people click _. 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. Be a part of this mission and join us! Learn more here: _ You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. _ 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: _ 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 us.reasonableaccommodations@novartis.com 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 $145,600.00 - $270,400.00 Skills Desired Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, People Management, Programming Languages, Reporting, Statistical Analysis, Waterfall Model

The Director, Medical Affairs (Nutrition) is responsible for leading and managing medical affairs for approved nutrition products and those in development. Areas of support include Product pre-launch and launch activities, Product Development, Product Lifecycle management, Business Development, and Post-Marketing medical affairs strategies. Collaborates cross-functionally and globally to ensure corporate goals and objectives are met at the highest levels. Directs the Region's medical needs for support of drugs and devices on the market, in development, and under evaluation. Responsible for cultivating and maintaining external relationships esp. with Health Care Providers (HCPs) and/or Health Care Decision Makers (HCDMs) to enable comprehensive scientific exchange around disease states and associated Company products. Must maintain scientific expertise in the application of treatment guidelines and clinical data as it pertains to disease states and associated Company products. Must be able to communicate complex medical and scientific concepts to a broad range of audiences. The Director, Medical Affairs, will also support execution of Medical Affairs strategy and activities where and as appropriate. The Director, Medical Affairs will lead the field clinical education team and ensure that the respective territory engagement plans are effectively executed per defined targets, following Fresenius Kabi compliance rules and code of conduct and that relevant medical and scientific insight is routinely shared to optimize the Medical Affairs strategy for the nutrition portfolio. *Priority will be given to candidates in the Chicagoland area who are able to regularly work at our Lake Zurich, IL site. *This position does not offer visa sponsorship either now or in the future. • Salary Range: $185,000-220,000., • Position is eligible to participate in an annual bonus plan with a target of 16% of the base salary., • Position is eligible to participate in our medium-term incentive plan., • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities., • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage., • Lead the strategic planning, launch, and lifecycle support of nutrition products including high-risk medications., • Lead the development and execution of medical affairs strategy to support successful product launch ensuring alignment with commercial, clinical development, regulatory teams and internal stakeholders., • Maintain the highest levels of professional integrity & performance standards by consistently providing high quality medical deliverables on time. Maintains a high standard for medical and scientific accuracy, representative of a comprehensive understanding of the medical concept at hand. Maintains a high level of professional expertise by staying abreast of current medical landscape with regard to key clinical conditions our products support., • Identify, engage, and build strong relationships with Key Opinion Leaders (KOLs), influencers in HCP community, scientific experts, and medical societies to support scientific exchange and advocacy., • Lead the nutrition team ensuring achievement of compliant and effective healthcare professional interaction for scientific exchange related to disease states and/or associated Company products per predefined engagement plans and targets., • Establish and maintain relationships with HCPs and HCDMs to provide scientific exchange related to disease states and/or associated Company products., • Represent the company at major medical and scientific conferences; manage planning and coordination of congress activities, including symposia, medical affairs booth presence, and thought leader engagements., • Oversee publication planning and execution, including abstracts, posters, manuscripts, and scientific communications, ensuring timely and compliant dissemination of clinical data., • Drive medical education initiatives for internal and external stakeholders, including training programs, advisory boards, and peer-to-peer education aligned with the product's scientific platform., • Provide scientific leadership and oversight for Investigator-Initiated Trials (IITs), including review, approval, and ongoing collaboration with investigators., • Collaborate cross-functionally to design and implement company-sponsored clinical studies to support product differentiation, real-world evidence generation, cost-effectiveness analysis, HEOR studies and post-marketing commitments., • Lead and manage a team of medical affairs professionals; provide coaching, development, and performance management to ensure high team effectiveness., • Collaborate with Global Medical Affairs in the support of USA-based clinical trials, both internal and external., • Review, develop, and approve clinical summaries in support of NDA 505(b)(2), ANDA, NDA applications., • Serve as a medical expert for on market parenteral nutrition products, products in development, and potential acquisition targets providing medical affairs strategies and due diligence for on market products and business development opportunities., • Responsible for writing and/or review of relevant Standard Operating Procedures (SOPs) pertaining to the role as needed. Job Requirements: • Medical/clinical professional degree required, such as Licensed Registered Dietitian., • Clinical Nutrition knowledge is required., • 10+ years of experience in the pharmaceutical industry in a medical affairs or clinical development role required., • 3+ years of hands-on experience in patient care and in hospital and/or clinic and/or home infusion settings is required, with demonstrated expertise in clinical nutrition including experience in managing formula selection for oral nutritional supplement use and tube feeding regimens., • 5+ years of clinical experience preferred., • 5+ years of direct people management experience with demonstrated ability to develop and lead high-performing teams., • Ability to understand and interpret the regulatory requirements under which drugs and devices are developed, reviewed, and supported after approval., • Experience with the clinical drug development process and product launch experience is highly preferred., • Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents., • Position will require travel (20-50%), including overnight stays. A valid US driver's license and clean driving record are required., • Ability to understand and interpret FDA 505(b)2, 505(b)1, 505 (j) submission requirements., • Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required. We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Description Summary #LI-Remote The Medical Science Liaison (MSL) role is a field based, customer-facing, non-promotional medical and scientific position. The MSL's key objective is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the potential strategic impact of critical insights. This is a field-based and remote opportunity supporting key accounts in an assigned geography: South Texas. The preferable location for the successful candidate would be to reside in San Antonio or Austin, Texas or near a major airport in territory. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Company will not sponsor visas for this position. Job Description Key responsibilities: The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy. The primary responsibility of the MSL is to engage with customers - customer engagements may include but are not limited to: emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within their territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle. Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence on the patient journey and in the disease space throughout the product development lifecycle to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate Provide clinical trial support for company sponsored trials facilitating relevant medical activities and working cross-functionally with Medical Affairs and Clinical Operations colleagues. Regularly and effectively collaborates with internal colleagues (e.g., HEOR, access, marketing, commercial, sales) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards. Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues (in accordance with Working Practice Documents). Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect day-to-day responsibilities. Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM. Champion emerging responsibilities as strategic priorities and territory needs evolve. Proactively drive personal and professional development. Essential Requirements: Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc.) Leveling Guidelines: the position will be filled at level commensurate with experience. Experience for Manager Level: 0-3 years of experience in a Field Medical position within the pharmaceutical industry or as an MSL is required OR3-5 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting preferred. Experience for Associate Director Level: Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Experience all levels: Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required. Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies. Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around them do the same. Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment. Adherence with Company policies, state and federal laws and regulations Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. Desirable Requirements: Previous experience in assigned or related therapeutic area is preferred. NOTE: Above level experience criteria are not an exhaustive list. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. Novartis Compensation Summary: The pay range for this position at commencement of employment is expected to be between; for Manager: $145,600 - $270,400 year and for Associate Director: $160,300 - $297,700 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. 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. 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 us.reasonableaccommodations@novartis.com 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 $160,300.00 - $297,700.00 Skills Desired Biostatistics, Clinical Practices, Clinical Research, Clinical Study Reports, Curious Mindset, Customer Relationship Management (CRM) Software, Disease Management, Drug Development, Education, Epidemiology, IT Tools, Medical Information, Medical Research, Medical Writing, Phase Iv Clinical Trial, Product Placement, Scientific Support

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 Specialist III, Regulatory Lifecycle Maintenance is responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assists with the preparation of dossiers in eCTD format. This role will provide a high level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements. Essential Functions • Prepare or review documents including investigator brochures, protocols, clinical study reports , annual reports, DSURs, PAERs, clinicaltrials.gov entries, and other lifecycle maintenance documents., • Compile, organize, and catalogue essential regulatory documents on all active clinical studies to maintain compliance with Health Authorities., • Review, edit and approve all final submissions to Health Authorities., • Assist in daily operations outside of essential BLAs and provide regulatory input on day-to-day issues and provide regulatory documents to other departments., • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan., • Assemble the reporting of clinical studies performed by IBRX or by CROs., • Draft written summaries for regulatory submissions including but not limited to, INDs, NDAs, and BLAs., • Provide support and training to others in the preparation, analysis, and documentation of studies., • Draft and review essential BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing, and reconciliation., • 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 a related field required; 5+ years of relevant regulatory clinical Science experience is required, or, • Master's degree in life sciences or a related field required; 3+ years of relevant regulatory clinical Science experience is required, • Experience in the preparation of the submission of clinical modules in eCTD format is preferred, • Familiar with organizing responses to Health Authority information requests is preferred, • Familiarization with regulatory submissions internationally is preferred. Knowledge, Skills, & Abilities • Knowledge of Health Authority clinical guidance documents and requirements, • Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Strong 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 Working Environment / Physical Environment • This position works on-site in Summit, NJ., • The 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., • They will work closely with scientific colleagues throughout the day, often on a project team basis., • 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. $132,000 (entry-level qualifications) to $145,200 (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 Hybrid Working: This role requires a hybrid working model based in East Hanover, New Jersey, with an expectation of 12 days per month onsite. Novartis cannot sponsor visas for this location. Location: East Hanover, United States Relocation Support: This role is based in East Hanover, United States. Novartis is unable to offer relocation support: please only apply if accessible. Imagine shaping the data that brings life-changing medicines to patients faster. As a Principal Clinical Data Scientist at Novartis, you will play a critical role in ensuring the integrity, quality, and timeliness of clinical trial data across entire programs or assigned trials. You will lead end-to-end data management activities, overseeing study delivery, driving key performance indicators, and ensuring inspection-ready data that supports timely submissions to health authorities. By introducing innovative, data-driven solutions, you will enable efficient and high-quality drug development. Working at the heart of cross-functional clinical trial teams, you will collaborate closely with data quality experts, clinical teams, and external partners, fostering a high-performing, well-organized team environment. Your work will directly influence clinical decision-making and ultimately help improve outcomes for patients worldwide. Job Description Key Responsibilities Lead end-to-end data management for multiple clinical trials or across programs from Phase I to IV. Drive study and/or program-level data strategies aligned with therapeutic area and organizational objectives. Coordinate internal and external data scientists to ensure high-quality, timely study delivery. Provide expert input to protocol design, ensuring data quality, feasibility, and efficient data collection. Identify and resolve data-related risks impacting database design, analysis, or reporting outcomes. Collaborate cross-functionally to communicate study progress, timelines, and key data management insights. Oversee design and standardization of electronic case report forms and data structures. Ensure audit readiness, quality control, and reliability of clinical databases and deliverables. Apply advanced tools and industry standards to enable robust reporting and data visualization. Contribute to process improvements and act as a data management expert in complex problem-solving. Essential Requirements Bachelor's degree in life sciences, computer science, pharmacy, nursing, or a related field. Proven experience managing clinical trial data across multiple studies and delivering to deadlines. Ideally, a minimum of 7+ years' experience in clinical data management. Strong knowledge of clinical trial methodology, good clinical practice, and medical terminology. Advanced ability to analyze and interpret data using programming or graphical user interface tools. Demonstrated leadership and collaboration skills in cross-functional, global team environments. Ability to identify risks, solve complex problems, and implement effective data management solutions. Excellent communication skills, with ability to influence stakeholders across functions and organizations. Experience mentoring colleagues and sharing knowledge to support team and project success. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between 119,700.00 - 222,300.00 USD 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. 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 us.reasonableaccommodations@novartis.com 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 $119,700.00 - $222,300.00 Skills Desired Clinical Data Management, Data Architecture, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategy, Master Data, Waterfall Model

Job Description Summary The Medical Science Liaison (MSL) role is a field based, customer-facing, non-promotional medical and scientific position. The MSL's key objective is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the potential strategic impact of critical insights. This territory will be responsible for covering Illinois. The preferable location for the successful candidate would be to reside in the Chicago metropolitan area. Must live within 50 miles of the border of this territory to be considered. Relocation is not available. Role Responsibilities include, but are not limited to • The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy, • The primary responsibility of the MSL is to engage with customers - customer engagements may include but are not limited to: emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within their territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle., • Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence on the patient journey and in the disease space throughout the product development lifecycle to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate* Provide clinical trial support for company sponsored trials facilitating relevant medical activities and working cross-functionally with Medical Affairs and Clinical Operations colleagues. • Regularly and effectively collaborates with internal colleagues (e.g., HEOR, access, marketing, commercial, sales) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards., • Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues (in accordance with Working Practice Documents)., • Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect day-to-day responsibilities., • Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM., • Champion emerging responsibilities as strategic priorities and territory needs evolve, • Proactively drive personal and professional development. Job Description Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc) Experience for Manager Level: • 0-3 years of experience in a Field Medical position within the pharmaceutical industry or as an MSL is required OR, • 3-5 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting preferred. Previous experience in assigned or related therapeutic area is preferred. Experience for AD Level: • Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR, • 5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Previous experience in assigned or related therapeutic area is preferred. Experience all levels: • Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required., • Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies., • Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around him/her do the same, • Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment, • Adherence with Company policies, state and federal laws and regulations, • Field-Based Region covering the state of Illinois. Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from territory border., • The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager, • Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). NOTE: Above level experience criteria are not an exhaustive list Field roles with a dedicated training period only: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. Field roles with a company car: Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving. The pay range for this position at commencement of employment is expected to be between; for Manager: $145,600 - $270,400 and for AD: $160,300 - $297,700 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 us.reasonableaccommodations@novartis.com 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 $160,300.00 - $297,700.00 Skills Desired Building Constructions, Business Analysis, Business Networking, Clinical Protocols, Clinical Research, Clinical Study Reports, Communication, Curious Mindset, Disease Management, Diversity and Inclusion (D&I), Drug Development, Epidemiology, Medical Information, Medical Research, Medical Writing, Microsoft Word, Phase Iv Clinical Trial, Product Placement, Scientific Support

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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences. Responsibilities • Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team, • For assigned programs and studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at the study level, • Interacts with and influences cross-functional team members to achieve program objectives, • Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions, • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits, • Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance, • Responsible for coaching and mentoring team members, • Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives, • Conducts study execution “lessons learned” across functions, • May include indirect supervision of employee as well as supervision of work of contract resourcesQualifications, • Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired., • Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience)., • In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred, • Demonstrated performance as a functional leader, • Demonstrated ability to influence others without direct authority, • Demonstrated ability to successfully coach / mentor in a matrix environment, • Demonstrated effective communication skills, • Demonstrated effective analytical 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 thisposting 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 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 anduntil 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Associate Director, Patient Centered Outcomes Research, is responsible for the design and execution of strategically-focused and innovative patient experience data (PED) evidence to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (e.g., Clinical Development & Operations, Regulatory, Commercial). The Associate Director, Patient-Centered Outcomes Research, will support multiple programs across therapeutic areas and cultivate strong partnerships to enable effective cross-functional collaboration with other product team members from internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs, Medical Affairs, and the Commercial organization. In addition, the Associate Director will support collaborations with external partners (e.g., industry consortiums, key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / HTA meetings and may lead and/or support negotiations in collaboration with cross-functional team members to drive internal strategy and alignment with global regulatory & reimbursement agencies. He / She serves as a subject matter expert (SME) on PED and patient-centered measurement strategies within HEOR and AbbVie to drive a patient-centric culture and adoption/uptake of standards and best practices for PED. The Associate Director will be responsible for several programs across AbbVie’s portfolio (e.g., spanning multiple products/ indications). Additional responsibilities for the Associate Director include developing annual strategic planning of PED aligned with TA / asset strategy and managing multiple projects and vendors to execute PED for their respective TA responsibilities. *This position can sit anywhere in the U.S. Responsibilities • Responsible for execution of global PED evidence generation and stakeholder engagement strategies that encompasses innovative research aligned with overall asset strategy across multiple therapeutic areas, • Leads management of projects to ensure timely execution of PED research to characterize patient outcomes, identify patient preferences and unmet needs, inform patient-focused measurement strategies, and develop innovative patient-relevant outcomes measures and endpoints to differentiate AbbVie’s portfolio and meet business and global needs, • Supports alignment of strategy with HEOR-Strategy counterparts and communicates strategy and translates results cross-functionally to key cross-functional teams that are part of Pipeline Commercial Model to facilitate alignment and integration of PED plans into the broader Integrated Evidence Plans, • Ensures the scientific quality and integrity of COA research through development of rigorous qualitative and quantitative study research proposals, protocols, analysis plans and reports, • Leads integration of COA measurement strategy into clinical development programs through clinical trial program support (e.g., protocol/SAP content development, results interpretation and CSR development) and ensures appropriate implementation of COAs on eCOA platforms in global programs Leads development, validation, and implementation of COAs measures for randomized controlled trials (RCTs) / observational studies, • Leads/contributes to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints and leads/participates in regulatory and reimbursement discussions and negotiations to optimize registration approval, product labeling & promotion and patient access decisions, • Develops strategic scientific communication plan including submission and presentation of research in peer-reviewed journals and at medical / methodological congresses, • Serves as internal SME on technical specialty areas to identify new methodologies and advancements in the field (e.g., COA methods, regulatory requirements to obtain COAs on labels, industry trends), • Develops and delivers standards/best practices and educational resources for functions across AbbVie to drive the integration of patient voice in development programsQualifications, • Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and, • Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred, • Minimum of 5 years of experience required, with relevant pharmaceutical industry or consulting experience in patient experience data research; clinical outcome assessment / patient reported outcome development, psychometric validation, and implementation; and medical product development and trial design, • Demonstrated ability in evaluation & development of PED from conceptualization through negotiations by global authorities, • Experience in preparing regulatory & HTA submissions, • Excellent interpersonal skills with an ability to leverage deep expertise to understand, respond and influence effectively across multiple internal and external customers, • Demonstrated ability to manage multiple priorities in rapidly changing environment, • Excellent written and verbal communication skills, • Experience in handling delivery of services across complex matrix environments and on a global level, • Excellent project management skills, • Demonstrated experience / knowledge of the pharmaceutical industry (knowledge of regulatory/compliance frameworks) and clinical trial design, • Knowledge of regulatory & HTA requirements for patient-centered endpoints, • Ability to effectively interpret and communicate research results to internal and external audiences, • Ability to work collaboratively to leverage other HEOR capabilities (Strategy, Geographies, other Centers of Expertise [CoEs] – Economic Modeling, Meta-Research, RWE Analytics), • Develop standards and respond quickly to business questions, • Travel – Position requires up to 15% travel 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 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access. • Provides scientific and technical support for assigned multiple myeloma products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned multiple myeloma products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training., • In cooperation with other medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned multiple myeloma products/projects., • Drives medical affairs related launch activities, identifies launch risks and develops & executes mitigations strategies and makes sure that medical affairs considerations are heard during regulatory negotiations, • Drives the execution of the molecule and disease specific publication plan based on the unmet needs, evolving data and evolving treatment landscape through a cross functional collaboration with publication lead and clinical development team, • Drives Medical Affairs strategies and be a key internal contact/subject matter expert. Responsible for delivery of strategic alignment plan, brand plan, gap analysis and integrated tactical plan., • Develops and executes innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally, • Ensures appropriate selection of investigator initiated studies and maintains oversight for appropriate execution., • Collaborates closely with HEOR and V&A team to develops and co-executes HEOR & access strategy., • May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia, • May assist with the scientific review, development, execution and communication of area/global medical affairs sponsored or supported clinical research activities., • Keeps abreast of evolving multiple myeloma treatment landscape as well as competitive landscape, other professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource and is able to translate this info into strategic implications., • 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., • Provides guidance to cross-functional team members to aid in the development of promotional materials., • Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs, • Oversees the work of a small team of Scientific/Associate Scientific Directors or Medical/Associate Medical directors, • Coordinates induction, mentoring, training, and development of others., • Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.Qualifications For US/Global Senior Medical Director: • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant multiple myeloma experience in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred., • Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 6+ years of experience is preferred., • Substantial understanding of multiple myeloma required., • 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 leadership skills in a cross-functional global team environment, • Ability to interact externally and internally to support global business strategy., • Must possess excellent oral and written English communication skills., • People leadership experience preferred For US/Global Scientific Director: • Advanced Degree PhD or PharmD., • Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of multiple myeloma required., • 7-10 years of experience in Medical Affairs with Global/US Medical Affairs experience highly preferred., • Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent 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 or real-world study independently with little supervision., • Proven leadership skills in a cross-functional global team environment, • Must possess excellent oral and written English communication skills., • People leadership 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 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionABOUT VITALIEF Vitalief is a trusted partner to Sponsors, CROs, and Sites across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver Consulting and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. POSITION OVERVIEW We are seeking a highly experienced, strategic yet hands-on Clinical Research Operations Leader to join our delivery team as a full-time, fully benefited employee. In this role, you will partner with a multi-location community hospital system to transform its research enterprise into a scalable, high-performing, world-class clinical research operation. As the primary subject matter expert (SME), this leader will collaborate closely with the Vitalief delivery team to design and implement enterprise-level operational initiatives, with a strong emphasis on Non-Oncology programs and enhancing cross-system communication and coordination. A central focus of the role will be leading the operational build-out and execution of a Cardiovascular clinical trials pilot, including infrastructure development, staffing strategy, workflow optimization, and technology deployment. WHY VITALIEF? • Professional Growth: Join a team of experienced practitioners who bring both business acumen and domain expertise., • Impactful Work: Contribute to scientific advancements that directly improve patient lives., • People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k) retirement plan, and robust healthcare options., • Flexible Work Location: Hybrid role with 2–3 days per week onsite in the Orange, NJ area., • Competitive Compensation: Base salary, performance bonus, and equity incentives. KEY RESPONSIBILITIES - What Success Looks Like: • Successful design, launch and operational stabilization of a scalable Cardiovascular research pilot across multiple hospital campuses and ambulatory sites., • Aligned research strategy with institutional priorities through close partnership with executive, clinical, and administrative leadership., • Established standardized workflows, SOPs and enterprise-wide performance metrics for research operations., • Strengthened investigator engagement and increased research participation across service lines., • Established scalable infrastructure and service line activation frameworks, in collaboration with investigators and sponsors, to reduce study activation timelines, enhance start-up predictability, and support sustainable research growth., • Successfully managed cross-functional initiatives within matrixed reporting environments and complex academic-clinical governance structures., • Transition from opportunistic research conduct to a deliberate, strategic, and scalable clinical research enterprise. QUALIFICATIONS • Bachelor’s degree required; Master’s degree in Clinical Research Administration, Public Health, Nursing, or related field strongly preferred., • Minimum of 7 to 10 years of progressive clinical research operations experience, including 3 to 5 years in leadership or management roles., • Experience building and launching a clinical research multi-location operation from scratch, enabling timely initiation of multiple studies across diverse therapeutic areas., • Demonstrated experience leading and supporting complex multi-site clinical research settings, including academic medical centers, affiliated and non-academic health systems, and disparate research locations., • Demonstrated experience managing complex drug, device, adaptive, or multi-arm trials., • Cardiovascular clinical research experience strongly preferred., • Expertise in study start-up optimization, IRB processes, and regulatory compliance., • Experience with CTMS platforms (e.g., OnCore) and Epic research integration., • Strong knowledge of research billing compliance and Medicare clinical trial requirements., • Proven ability to develop SOPs, quality systems, and performance dashboards., • Experience strong relationships with sponsors and CRO partners to enhance site reputation and repeat business opportunities., • Strong executive presence with the ability to influence across matrixed environments., • Demonstrated success leading operational transformation or research program development initiatives. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR r6vZMkintD

Job Description Laboratory Technician Title: Laboratory Technician Location: Secaucus, NJ Reports to: Laboratory Manager Per diem Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The laboratory technician performs a variety of laboratory procedures as required by the study protocol. Laboratory technicians are responsible for assisting the Laboratory Manager, Principal Investigator, Clinical Research Coordinators, and other medical professionals in the preparation and handling of specimens, analyzing results, and maintaining laboratory equipment. Laboratory Technicians ensure accuracy, quality control, and adherence to safety protocols, contributing directly to scientific research, development of new products, or medical diagnostics. Roles & Responsibilities: • Performs routine laboratory procedures including specimen labeling, collection, processing, and shipping in accordance with established SOPs and/or study protocol under the supervision of the Laboratory Manager, Clinical Research Coordinator, Principal Investigator, and Sub-Investigators., • Operate and maintain laboratory equipment such as centrifuges, pipettes, and refrigerators/freezers., • Develop a strong working knowledge of the study protocols and flow chart of study procedures and implement study procedures in full compliance with protocol requirements., • Maintain accurate and timely documentation in laboratory or study-specific documents, temperature logs, and shipping logs., • Perform environmental monitoring and equipment temperature checks to ensure proper specimen storage conditions., • Assist with inventory management, restocking supplies, and maintaining organized work areas., • Ensure compliance with safety, quality, and regulatory standards (GCP and internal QA procedures)., • Support weekend and surge workload coverage as needed based on operational demands., • Assist Laboratory Manager in any task as needed. Education, Experience & Skills Required: • Associate or BS in biology, chemistry, or related area, or completion and certification of Lab Technician course from an accredited or allied health training school., • 1 year of experience in clinical research laboratory or related medical field., • Proficiency in laboratory techniques and laboratory equipment operation., • Good communication skills., • Excellent organization and planning skills. Salary: $18-$22/hour Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description Assistant Clinical Research Coordinator Title: Assistant Clinical Research Coordinator Location: Secaucus, NJ, onsite Reports to: Manager of Clinical Operations. Full-time/ Hourly Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Assistant Clinical Research Coordinator Assists the Clinical Research Coordinator in developing strategies for implementing study procedures in compliance with the study protocol. Roles & Responsibilities: • Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures., • Develops a strategy for implementing study procedures in compliance with the study protocol., • Performs study procedures (e.g., obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators., • Records study data in the source documents. Evaluates and reviews study data to ensure accuracy and completeness., • Assists the clinic team in transcribing study data from source documents to sponsor designated electronic case report forms., • Resolves data queries in conjunction with the sponsor., • Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor., • Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the sponsors and IRB., • Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator., • Maintains investigator/sponsor files in accordance with the FDA and GCP Guidelines., • Assists in the screening of research subjects to evaluate their eligibility for a clinical study., • Creates and performs QC procedures., • Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators., • Other assigned. Education, Experience & Skills Required: • At least 6 months’ experience supporting clinical research study conduct., • Must possess a general knowledge of applicable clinical research regulatory requirements; general knowledge of GCP and ICH guidelines is preferred., • Strong computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint., • Strong written and verbal communication skills., • Effective time management and organizational skills., • Attention to detail and accuracy in work., • Knowledge of applicable protocol requirements. Salary: $25.00/hour Benefits: • 401k Employer Match with immediate vesting, • Vision Insurance, • Medical and Dental Insurance with multiple coverage options, • FSA (Medical, Dependent Care, and Commuter), • Short Term Disability, • Long Term Disability, • Life Insurance, • Generous Paid Holidays and PTO Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job DescriptionSummary: The Clinical Research Assistant will assist the Clinical Research Coordinator and the Principal Investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites. Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties.Duties and Responsibilities: • Assists with the creation and completion of study related documents and new study preparation., • Assists with the completion of regulatory submissions and maintains regulatory files as directed., • Acts as a secondary liaison with sponsors., • Assists with the preparation for study monitor visits as directed., • Completes case report forms as directed., • Creates reports as requested., • Completes study directed assessments with patients to include, but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment., • Assists with subject screening and recruitment as directed., • Updates Clinical Trial Management Software (CTMS) as directed., • Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume., • Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.Education/Experience:High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience.Certificates and Licenses:, • Clinical research certification preferredKnowledge, Skills, and Other Abilities:, • Ability to demonstrate competence in oral and written communication, • Bilingual (English/Spanish) preferred, • Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor, • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner, • Medical knowledge, including medical terminology, • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization., • Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.Work Environment and Physical Demands:The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • Work is performed in an office/laboratory and/or a clinical environment., • Exposure to biological fluids and/or bloodborne pathogens., • Personal protective equipment required such as protective eyewear, garments, and gloves., • Occasional travel may be required domestic and/or international., • Ability to work in an upright and/or stationary position for 6-10 hours per day., • Frequent mobility required., • Occasional squatting, kneeling, or bending., • Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.Perks of working at Summit Pinnacle Clinical Research:, • 401k, • Medical, dental, vision, long term disability, short term disability, FSA, and life insurance, • 3 weeks of paid time off, • 14 paid company holidays, • Scrub voucher (specific positions apply), • And more!Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

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 www.abbvie.com. 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., • Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred. For Medical Director: • 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., • Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred. Other • 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionABOUT VITALIEF Vitalief is a trusted partner to Sponsors, CROs, and Sites across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver Consulting and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. POSITION OVERVIEW We are seeking a highly experienced, strategic yet hands-on Clinical Research Operations Leader to join our delivery team as a full-time, fully benefited employee. In this role, you will partner with a multi-location community hospital system to transform its research enterprise into a scalable, high-performing, world-class clinical research operation. As the primary subject matter expert (SME), this leader will collaborate closely with the Vitalief delivery team to design and implement enterprise-level operational initiatives, with a strong emphasis on Non-Oncology programs and enhancing cross-system communication and coordination. A central focus of the role will be leading the operational build-out and execution of a Cardiovascular clinical trials pilot, including infrastructure development, staffing strategy, workflow optimization, and technology deployment. WHY VITALIEF? • Professional Growth: Join a team of experienced practitioners who bring both business acumen and domain expertise., • Impactful Work: Contribute to scientific advancements that directly improve patient lives., • People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k) retirement plan, and robust healthcare options., • Flexible Work Location: Hybrid role with 2–3 days per week onsite in the Orange, NJ area., • Competitive Compensation: Base salary, performance bonus, and equity incentives. KEY RESPONSIBILITIES - What Success Looks Like: • Successful design, launch and operational stabilization of a scalable Cardiovascular research pilot across multiple hospital campuses and ambulatory sites., • Aligned research strategy with institutional priorities through close partnership with executive, clinical, and administrative leadership., • Established standardized workflows, SOPs and enterprise-wide performance metrics for research operations., • Strengthened investigator engagement and increased research participation across service lines., • Established scalable infrastructure and service line activation frameworks, in collaboration with investigators and sponsors, to reduce study activation timelines, enhance start-up predictability, and support sustainable research growth., • Successfully managed cross-functional initiatives within matrixed reporting environments and complex academic-clinical governance structures., • Transition from opportunistic research conduct to a deliberate, strategic, and scalable clinical research enterprise. QUALIFICATIONS • Bachelor’s degree required; Master’s degree in Clinical Research Administration, Public Health, Nursing, or related field strongly preferred., • Minimum of 7 to 10 years of progressive clinical research operations experience, including 3 to 5 years in leadership or management roles., • Experience building and launching a clinical research multi-location operation from scratch, enabling timely initiation of multiple studies across diverse therapeutic areas., • Demonstrated experience leading and supporting complex multi-site clinical research settings, including academic medical centers, affiliated and non-academic health systems, and disparate research locations., • Demonstrated experience managing complex drug, device, adaptive, or multi-arm trials., • Cardiovascular clinical research experience strongly preferred., • Expertise in study start-up optimization, IRB processes, and regulatory compliance., • Experience with CTMS platforms (e.g., OnCore) and Epic research integration., • Strong knowledge of research billing compliance and Medicare clinical trial requirements., • Proven ability to develop SOPs, quality systems, and performance dashboards., • Experience strong relationships with sponsors and CRO partners to enhance site reputation and repeat business opportunities., • Strong executive presence with the ability to influence across matrixed environments., • Demonstrated success leading operational transformation or research program development initiatives. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR tM42k6zqBG

Job Description Summary: The Quality Associate will perform independent examination (i.e., audit) of multiple trial related activities and documents, to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to the protocol, standard operating procedures (SOPs), GCPs and the reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.). The Quality Associate is responsible for building and maintaining effective working relationships with internal staff/external vendors. The ideal candidate will be responsive, thoughtful, self-motivated, highly organized, and a team-player. This role reports directly to the VP of Compliance. Under supervision of a mentor/coach, the Quality Associate will be responsible for: Duties and Responsibilities: Quality Duties: • Responsible for quality control checks on study documents related to the conduct of the clinical trial in different therapeutic areas and phases, • Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements), • Will also support training for site staff, this include creating and presenting quality content., • Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, Data Services), • Assist with writing QA audit or QC reports, • Works with internal clinical research team to ensure that inspection findings are clearly communicated and understood, • Evaluates inspection finding responses to ensure they are written to address the findings appropriately, • Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced, • Introduction to in-life audits, process audits, and vendor audits, • Identifies and communicates opportunities for process improvement based on audit and inspection observations, • Maintains necessary documentation of QA records and study files, • Notifies management of observed quality and compliance trends in the areas inspected, • Interprets GCP, and associated regulatory documents to facilitate auditing and process improvement recommendations, • Carries out appropriate self-development efforts as directed, • Performs other related duties as assigned Regulatory Duties: • Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to theconduct of clinical pharmaceutical and device protocols, • Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures, • Works under limited supervision to assure compliance with federal regulations relating to human subject research, • Understands and applies ethical principles and multiple regulations to clinical research protocols, • Review study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements, • Prepares, maintains, and provides oversight to all research-related regulatory documents, • Populates and coordinates the entire process of initial regulatory documents' submission to the IRB, sponsors, and state or federal regulatory offices as necessary, • Compiles study information and submits initial, continuing, and final reports to the IRB and/or sponsor, • Prepares applicable submission forms and submits updated documents, including but not limited to amendments, addendums, investigator's brochures, safety information, form FDA 1572s, and informed consent documents, • Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records, • Prepares for monitoring visits and audits, • Manages and updates employee curriculum vitas and ensures copies of all current and applicable medical licenses are on file, • Creates error free written documents and reports such as cover letters, notes-to-file, and memos, • Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor, • Interacts with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients and attends site initiation visits, • Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume, • Other duties as assigned Duties, responsibilities, and activities may change, or new ones may be assigned at any time. Qualifications: • Bachelor’s Degree in scientific area of study or equivalent combination of education, training, and experience, • Previous experience in a clinical research environment or equivalent work environment, • 2-4 years of previous experience as regulatory and/or quality associate in clinical research, • Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred, • Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint), • Familiarity with clinical trial management system software, preferably Clinical Research IO, • Basic medical knowledge, including medical terminology, • Demonstrated competence in oral and written communication, • Must complete CITI and GCP training certification, • Demonstrated organizational skills and outstanding time management, including keen attention to detail, • Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission, • Comply with the company policies, code of ethics, and guiding values at all times Competencies: • Strong analytical and problem-solving skills, • Detail oriented with the ability to perform at a high level of accuracy, • Proactive at identifying and addressing issues in real time, • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner, • Must handle confidential matters and sensitive information with discretion and judgment, • Ability to research regulatory issues and provide recommendations for resolution, • Ability to handle multiple projects simultaneously, • Ability to manage small projects and work independently, • Ability to understand and interpret clinical research protocols and other applicable sponsor documentsWork Environment and Physical demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. • Work is performed in an office/laboratory and/or a clinical environment., • Exposure to biological fluids and/or bloodborne pathogens., • Personal protective equipment required such as protective eyewear, garments, and gloves., • Travel between two NJ sites is required, • Ability to work in an upright and/or stationary position for 6-10 hours per day., • Frequent mobility required., • Occasionally squatting, kneeling, or bending., • Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.Salary and Benefits: Summit Pinnacle Clinical Research provides each of our team members with opportunities for personal and professional growth in a team-oriented working environment. We offer competitive pay, excellent benefits, and the chance to grow professionally in the healthcare industry. The salary range for this position will be commensurate with experience. • 401k, • Medical, dental, vision, long term disability, short term disability, HSA, and life insurance, • 3 weeks of paid time off, • 14 paid company holidays, • Scrub voucher (specific positions apply), • And more! Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

The Oncology Research Nurse Coordinator is a highly skilled Registered Nurse who plays a pivotal role in the execution and management of oncology clinical trials. ONS Oncology Certified Nurse (OCN) or Advanced OCN (AOCN) preferred. From protocol activation through patient enrollment and ongoing stud

Registered Nurse, Oncology Research RN. The Oncology Research Nurse Coordinator is a highly skilled Registered Nurse who plays a pivotal role in the execution and management of oncology clinical trials. At RWJBarnabas Health, our employees are at the heart of everything we do.

A global clinical research provider is seeking experienced Clinical Data Management Leads to oversee data management delivery for global clinical trials. Candidates should have a bachelor’s degree and at least 7 years in clinical data management, including 5 years in a leadership role. This fully

Job Description Receptionist/Recruiter Location: Secaucus, NJ Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: Responsible for serving as the receptionist of the Clinical Research Center. In addition to working as the receptionist for the Frontage CRC, maintain an organized office environment in the day-to-day operation of the Frontage Clinical Research Center (CRC). Supervises: None Education, Experience & Skills Required: • High School Diploma, Associate’s preferred. Medical background is required., • Minimum 3-5 years of experience working as receptionist for a large health care or research organization., • Must have experience in analyzing and solving problems, communicate effectively, both verbally and in writing, created, composed and edited written materials, gathered data, compiled information, organized and establish priorities. Experience in taking notes, dictation and transcription., • The ideal candidate will possess a minimum of 3-years progressively responsible experience with advanced computer skills in MS Word (type 50 WPM), extensive spreadsheet on Excel proposals, PowerPoint presentations, Internet searching capability and organization of e-Recruitment system. Must have database management and records maintenance experience. Bilingual (English and Spanish) language skills desirable. Roles & Responsibilities: • Primary receptionist responsibilities for the Clinical Research Center., • Assist and oversee visitors (including research subjects) with sign-in and sign-out procedures of the Clinical Research Center., • Interact with study volunteers, sponsors and vendors and other clients. Forward all phone calls to appropriate department and staff., • Maintain appointment calendar and make travel and lodging arrangements; compose and produce business correspondence, reports or directs related materials, and reviews and sign, as authorized., • Edit documents; respond to inquiries and requests for information requiring knowledge of departmental and Frontage CRC policies and procedures., • Prepare/distribute related materials, record minutes, and summarize for typing and distribution., • The candidate will be responsible for assisting and actively participate in study subject screening and enrollment process., • Strong interpersonal skills, flexibility, and the ability to function in a fast-paced environment as a team player are essential., • Familiarity with the basic eligibility requirements and study procedures for specific study protocols and the process of a volunteer participating in a research study (e., ability to explain basic study eligibility requirements and procedures to a lay person)., • Recruiter for research subjects. Salary: $18 - $22 per hour Benefits: • 401k Employer Match with immediate vesting, • Vision Insurance, • Medical and Dental Insurance with multiple coverage options, • FSA (Medical, Dependent Care, and Commuter), • Short Term Disability, • Long Term Disability, • Life Insurance, • Generous Paid Holidays and PTO Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description Clinical Research Nurse (per diem) Title: Clinical Research Nurse (per diem) Location: Secaucus, NJ (On-site required) Reports To: Executive Medical Director and Principal Investigator Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: We are seeking a licensed and detail-oriented Clinical Research Nurse in support of clinical trials conducted at Frontage Clinical Services. in support of clinical trials conducted at Frontage Clinical Services. responsible for working under the guidance of the Investigators; Management, Study Coordinator and Supervisor, to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services site in Secaucus. Responsibilities: • Assist Clinical Study Coordinators in any task as needed., • Administer Medications (including IV administration route) per doctor’s and protocol instructions., • Perform study procedures (e.g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators, Director, Associate Director, and Clinical Research Coordinators., • Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness., • Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures., • Develops a strategy for implementing study procedures in compliance with the study protocol., • Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor., • Responsible for maintaining emergency medication in the crash cart., • Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator., • Assists in the screening of research subjects to evaluate their eligibility for a clinical study., • Creates and performs QC procedures., • Assists in the reconciliation of IPs and maintaining accountability., • Acts independently to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.), • Shows desire and initiative to increase knowledge and skills in clinical research. Education and Requirements: • Bachelors in Science in Nursing., • Registered Nurse in the State of New Jersey, • Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Services and sponsor personnel., • 1-3 years' experience in clinical research is desirable. Knowledge of FDA regulatory requirements is necessary, or mandatory on-job training will be required. Salary: $45-$55/hour Benefits: • 401k Employer Match with immediate vesting, • Vision Insurance, • Medical and Dental Insurance with multiple coverage options, • FSA (Medical, Dependent Care, and Commuter), • Short Term Disability, • Long Term Disability, • Life Insurance, • Generous Paid Holidays and PTO Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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