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Summary Our client, a Fortune 500 medical device company, has engaged GForce Life Sciences to provide a Clinical Study Supply Coordinator to work closely with the Clinical Project Manager and Medical Affairs teams to fulfill their study product related deliverables in conjunction with the Quality Management system SOPs and regulatory requirements. This individual will play an integral role and have responsibility for clinical study supply inventory, review, preparation, and efficient shipping of clinical trial products to contracted sites. Responsibilities • Collaborate with the Clinical Product Management Group as required., • Assist with procuring study supplies, monitoring inbound shipments and accruing costs per study., • Maintain Study Product and Study Supply inventory using Inventory management database. (Must be able to carry packages up to 30 lbs), • Assist in assembly of kits, formatting and printing labels, over-labeling in accordance with protocol and product accountability practices., • Inspect Study Product, including packaging and labeling per SOP and Study-specific requirements., • Oversight of the storage of Study Product and Study Supplies under secure, controlled conditions which are compliant with GCP and other applicable regulations and guidelines, and which adhere to the required limits of temperature and humidity., • Assist in the disposition of product and/or supplies returned at the end of each study, including documentation, destruction, or restocking., • Assist with packaging, shipment documentation, and shipping of material (domestic and International)., • Tracking all inbound and outbound shipments., • Tracking Documentation and filing in eTMF. Requirements • A minimum AAS in Science, or other Allied Health professions., • A minimum of 1 year experience in Medical Device clinical trials, pharmaceutical, biotechnology or related firm, including direct exposure to the process of clinical study supply (IUO and Ancillary) management and execution. Terms & Start • Onsite 5 days/week in Paterson, NJ, • 12 month contract, • Start ASAP, • Benefits included (Medical, Dental, Vision, and 401k options)

The Clinical Trial Associate (CTA) provides essential operational and administrative support to clinical trial teams to ensure the effective planning, execution, and close-out of clinical studies. The role supports Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and project teams in maintaining trial documentation, tracking study progress, and ensuring compliance with ICH-GCP, SOPs, and regulatory requirements. Key Responsibilities Trial Management Support • Support study start-up, conduct, and close-out activities across assigned clinical trials, • Assist CRAs and CTMs with day-to-day trial operations and coordination, • Track study milestones, deliverables, and timelines Documentation & TMF Management • Maintain the Trial Master File (TMF) ensuring completeness, accuracy, and inspection readiness, • Collect, review, file, and archive essential study documents, • Support TMF quality checks and reconciliation activities Site & Vendor Coordination • Support site initiation, monitoring, and close-out activities, • Track site documents including CVs, training records, regulatory approvals, and essential correspondence, • Coordinate logistics for investigator meetings, monitoring visits, and study materials Regulatory & Compliance Support • Assist with regulatory submissions and maintenance of regulatory files, • Ensure documentation complies with ICH-GCP, SOPs, and applicable regulations, • Support audit and inspection readiness activities Data & System Management • Update and maintain clinical trial tracking tools and systems (eTMF, CTMS, SharePoint, etc.), • Support data entry and reconciliation across clinical systems Required Qualifications • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field, • 1–3 years of experience in clinical research or clinical trial operations, • Basic understanding of clinical trial processes and ICH-GCP guidelines, • Experience working with eTMF and CTMS systems, • Strong organizational and documentation skills, • Excellent written and verbal communication abilities Preferred Qualifications • Experience in CRO or FSP environment, • Exposure to global clinical trials, • Experience supporting Phase I–IV clinical studies, • Familiarity with sponsor-specific SOPs and processes Key Competencies • Attention to detail and quality focus, • Strong coordination and follow-up skills, • Ability to manage multiple tasks and timelines, • Collaborative team player, • Proficiency in MS Office (Excel, Word, PowerPoint) Work Environment • Office-based / hybrid / remote (as applicable), • May require occasional travel for investigator meetings or training

Job Title: Clinical Product Management Associate (Entry‑Level) Location: Franklin Lakes, NJ Pay Rate: $20–$23/hour Must Haves: • AAS in Science or related Allied Health field, • 1+ year experience in clinical trials, pharma, biotech, or medical device environment, • Exposure to clinical study supply management (IUO / Ancillary), • Ability to lift up to 30 lbs and perform repetitive labeling/kitting tasks, • Inventory management system experience, • eTMF documentation exposure

The Center for Multiple Sclerosis (MS) and Related Diseases in the Department of Neurology at Hackensack University Medical Center (HUMC), a major academic medical center within the Hackensack Meridian Health( HMH) system, seeks to employ a full-time BC/BE neurologist with fellowship training in MS, neuromyelitis optica & related disorders & interest in teaching neurology and other residents and medical students. The Center boasts a robust clinical trial program with Phase 1b, 2, 3, and 4b studies, including CAR-T studies and integrated digital solutions. The Center seeks candidates with an interest in outcomes research, clinical trials & translational research. The Center fosters an interprofessional approach in which neurologists, psychologists, neurorehabilitation specialists, pain management physicians, neuro-ophthalmologists & social workers who are cognizant of health care disparities, strive to provide patient-centered care, accurate diagnoses, state-of-the-art treatment, opportunities for clinical trial participation & to maximize community living. Faculty rank at Hackensack Meridian School of Medicine will be commensurate with experience. This position will be recruited by Krupa Pandey, MD, Director, Division of Multiple Sclerosis & Vice-Chair of Research for the Department of Neurology & Associate Professor of Neurology at the School of Medicine, and Florian P. Thomas, MD, PhD, Professor & Chair of the Neuroscience Institute & the Department of Neurology at HUMC & the School of Medicine. The Center is a nationally recognized leader in MScare. It is accredited as a Center for Comprehensive MS Care by the National MS Society and is a member of the Consortium of Multiple Sclerosis Centers. The Center is led by Dr. Krupa Pandey, a fellowship-trained MS specialist, features 2 other MS specialists, an APN, and 2 registered nurses. The Center has over 1250 established MS patients and is rapidly growing. HMH is the largest, most comprehensive, and integrated network in New Jersey, with 18 hospitals and more than 500 patient care and physician practice locations throughout the state. It comprises three academic medical centers (all featuring Comprehensive Stroke Centers), and has a dedicated team of over 36,000 members and 7,000 physicians. HUMC is consistently recognized for its excellence: For 2025-2026, U.S. News & World Report ranked HUMC as the #1 hospital in New Jersey and the New York metro area, with Neurosurgery-Neurology being in the top 50 since 2021. HUMC is the first hospital in New Jersey and only the second in the nation to achieve Magnet recognition for nursing excellence seven consecutive times. HUMC has also been distinguished as one of Healthgrades' "America's 50 Best Hospitals. It is located 8 miles west of Northern Manhattan. The successful candidate will possess the following qualifications: • Excellent clinical skills, • Fellowship trained in Neuroimmunology, • Board Eligible in Neurology, • Ability to obtain professional licensure, DEA and CDS licenses in New Jersey, • Track record of teaching medical students and residents, • Track record of scholarship, • Has 100+ Team Members. Prominent specialties include Epilepsy, MS, Stroke, Neurosurgery, Neuro-Oncology, Movement Disorders, Neuro-Ophthalmology, Neurogenetics, Neurocritical Care, Sleep Medicine, Hereditary Neuropathy, Headache/Pain Medicine, TBI/Concussion & ALS, • Active Clinical Research Unit led by physician-director with several coordinators & multiple ongoing sponsored & investigator-initiated research projects in MS, Stroke, Spinal Cord Injury, Hereditary Neuropathy, Pain, ALS, Dementia & Movement Disorders HOW TO APPLY: Nancy Massa Physician Recruiter Email: Phone: 732-890-9339 HMH is committed to pay equity and transparency for our team members. The minimum base salary for this position is $228,730.. The posted rate of pay in this job posting is a reasonable good-faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting base salary is provided for informational purposes only and is not a guarantee of a specific offer. The base compensation determined at the time of the offer may be different than the posted base salary based on a number of non-discriminatory factors, including but not limited to: Specialization: Area of specialization and sub-specialization. Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant experience in the areas of specialization and sub-specialization. Leadership: Relevant experience as a department chair or chief, practice group leader, or other leadership roles. Education and Certifications: Degrees attained, residencies, fellowships, board certifications, research, and publications. Productivity: Levels of productivity, quality, and patient satisfaction. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the specialty and/or sub-specialty. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. In addition to our compensation for full-time and part-time (20+ hours/week) positions, HMH offers a comprehensive benefits package, including health, dental, vision, tuition reimbursement, and retirement benefits. The final compensation and benefits package will be discussed during the interview process.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers (Health Care Providers, researchers, professional organization leadership, and population-based decision makers) in the areas of Eisai's interest. The MSL brings relevant insights from the field on research developments, treatment landscape and new concepts in medical treatment. The impact that a MSL will have to the organization include the following: a) as representatives of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for communication between Eisai Research and the medical community regarding ideas for future research with Eisai's products; and c) provide corporate value through demonstrated leadership and participation in strategic thinking. Job DescriptionJob SummaryThe Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers(healthcare providers, researchers, professional organization leadership, and population-based decision makers) in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of the customer's needs, issues and priorities as they relate to Eisai's strategic business plan. TheMSL/Sr. MSLbrings relevant insights from the field on research developments, treatment landscape and new concepts in medical treatment. The MSL/Sr. MSL will assume a leadership role by teaching, coaching and mentoring new or less experienced MSLs and by assuming responsibility for special projects as they arise.The impact that a MSL/Sr. MSL will have on the organization includes the following: a) as a representative of Eisai,theMSL/Sr. MSL will communicate key information about Eisai, the company and itshhc mission;b) provide key scientific and clinical information about Eisai's products; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research with Eisai's products, and c) provide corporate value through demonstrated leadership and participation in strategic thinking.Essential FunctionsProduct/Therapeutic Area Support to External Stakeholders • Act as the primary clinical/scientific resource toHealthcare Providers(HCPs) in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in the therapeutic areas in which Eisai has current and future interests., • Share knowledge and participate in scientific exchanges and interactions with identified KOLs., • Present clinical, scientific and economic data on Eisai's products and relevant therapeutic areas to population-based decision-makers, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr. MSLactivities, as required and assigned by the management., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs., • Develop, implement and present to management plans to support Medical Affairs strategic direction for assigned territory.Training/Education Resource, • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data., • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives., • Serve as technical/scientific subject matter resource to Eisai commercial personnel, if requested., • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performanceevaluation;assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning.Research Support, • Facilitate review and follow up of submitted Investigator-InitiatedStudies(IISs) and assist with Eisai sponsored trials., • Serve as primary contact to external investigators who submit IISs. The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored post-marketing studies.Professional Organization Support, • Lead field medical efforts in support of Eisai's collaboration and interactions with professional organizations/societies&advocacy groups, as required.Educational RequirementsRequires an advanced, terminal Doctorate level (D-level) degree in medical or health sciences (e.g. MD, PhD, PharmD, DPH, EdD).Experience, • For MSL 0-3years of experience in the pharma/biotech industry/clinical pharmacist/research/ related experience in a scientific or clinical setting, preferably as MSL., • For Sr. MSL, a minimum of 3 years MSL experience in Oncology/Hematology., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred., • Knowledge of treatment guidelines, clinical research processes, FDA regulations and OIG guidelines are required., • Knowledge and experience within Eisai desired therapeutic area(s) and ability to communicate with confidence and accuracy across multiple disease states., • Established relationships with key opinion leaders and knowledge of institutions in therapeutic areas of interest.Other Skills and Abilities:, • Excellent presentation and teaching skills., • Strong overall written and verbal communication skills., • Demonstrated ability to assess issues and think strategically., • Demonstrated ability and experience working cross-functionally., • Demonstrated ability to anticipate, organize, plan and handle multiple changing priorities., • Demonstrated ability to work independently and not requiring close supervision while adhering to Medical Affairs strategic direction., • Ability and interest in coaching and mentoring less experienced MSLs. Ability to lead and motivate team members without a direct reporting relationship., • Ability and interest in leading and participating in projects while effectively balancing projects with field work., • Demonstrated ability to analyze complex situations and proactively identify opportunities/issues;effectivelysolve problems that cross functional boundaries., • Committed to the concept of team and working within the framework of the Medical Affairs Department and Eisai organization, including as it pertains to compliance with policies, systems and practices., • Sound computer skills including applications for word processing, producing slide materials and working with spreadsheets., • Previous established relationships with KOLs in Oncology/Hematology., • Possesses anunderstandingof the pharmaceutical corporate environment and appreciation for commercialoperations,including marketing and sales strategies., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • Domestic and international travel may include spending time at cancer trial sites/institutions, conference center, offices and hotels., • Possesses and maintains a valid driver's license. As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Oncology - DC, DE, MD and WV is from :$160,100-$210,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

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

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

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

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers (Health Care Providers, researchers, professional organization leadership, and population-based decision makers) in the areas of Eisai's interest. The MSL brings relevant insights from the field on research developments, treatment landscape and new concepts in medical treatment. The impact that a MSL will have to the organization include the following: a) as representatives of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for communication between Eisai Research and the medical community regarding ideas for future research with Eisai's products; and c) provide corporate value through demonstrated leadership and participation in strategic thinking.Job SummaryThe Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers(healthcare providers, researchers, professional organization leadership, and population-based decision makers) in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of the customer's needs, issues and priorities as they relate to Eisai's strategic business plan. TheMSL/Sr. MSLbrings relevant insights from the field on research developments, treatment landscape and new concepts in medical treatment. The MSL/Sr. MSL will assume a leadership role by teaching, coaching and mentoring new or less experienced MSLs and by assuming responsibility for special projects as they arise. The impact that a MSL/Sr. MSL will have on the organization includes the following: a) as a representative of Eisai,theMSL/Sr. MSL will communicate key information about Eisai, the company and itshhc mission;b) provide key scientific and clinical information about Eisai's products; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research with Eisai's products, and c) provide corporate value through demonstrated leadership and participation in strategic thinking. Essential FunctionsProduct/Therapeutic Area Support to External Stakeholders • Act as the primary clinical/scientific resource toHealthcare Providers(HCPs) in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in the therapeutic areas in which Eisai has current and future interests., • Share knowledge and participate in scientific exchanges and interactions with identified KOLs., • Present clinical, scientific and economic data on Eisai's products and relevant therapeutic areas to population-based decision-makers, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr. MSLactivities, as required and assigned by the management., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs., • Develop, implement and present to management plans to support Medical Affairs strategic direction for assigned territory. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data., • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives., • Serve as technical/scientific subject matter resource to Eisai commercial personnel, if requested., • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performanceevaluation;assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning. Research Support • Facilitate review and follow up of submitted Investigator-InitiatedStudies(IISs) and assist with Eisai sponsored trials., • Serve as primary contact to external investigators who submit IISs. The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored post-marketing studies. Professional Organization Support • Lead field medical efforts in support of Eisai's collaboration and interactions with professional organizations/societies&advocacy groups, as required. Educational RequirementsRequires an advanced, terminal Doctorate level (D-level) degree in medical or health sciences (e.g. MD, PhD, PharmD, DPH, EdD). Experience • For MSL 0-3years of experience in the pharma/biotech industry/clinical pharmacist/research/ related experience in a scientific or clinical setting, preferably as MSL., • For Sr. MSL, a minimum of 3 years MSL experience in Oncology/Hematology., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred., • Knowledge of treatment guidelines, clinical research processes, FDA regulations and OIG guidelines are required., • Knowledge and experience within Eisai desired therapeutic area(s) and ability to communicate with confidence and accuracy across multiple disease states., • Established relationships with key opinion leaders and knowledge of institutions in therapeutic areas of interest. Other Skills and Abilities: • Excellent presentation and teaching skills., • Strong overall written and verbal communication skills., • Demonstrated ability to assess issues and think strategically., • Demonstrated ability and experience working cross-functionally., • Demonstrated ability to anticipate, organize, plan and handle multiple changing priorities., • Demonstrated ability to work independently and not requiring close supervision while adhering to Medical Affairs strategic direction., • Ability and interest in coaching and mentoring less experienced MSLs. Ability to lead and motivate team members without a direct reporting relationship., • Ability and interest in leading and participating in projects while effectively balancing projects with field work., • Demonstrated ability to analyze complex situations and proactively identify opportunities/issues;effectivelysolve problems that cross functional boundaries., • Committed to the concept of team and working within the framework of the Medical Affairs Department and Eisai organization, including as it pertains to compliance with policies, systems and practices., • Sound computer skills including applications for word processing, producing slide materials and working with spreadsheets., • Previous established relationships with KOLs in Oncology/Hematology., • Possesses anunderstandingof the pharmaceutical corporate environment and appreciation for commercialoperations,including marketing and sales strategies., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • Domestic and international travel may include spending time at cancer trial sites/institutions, conference center, offices and hotels., • Possesses and maintains a valid driver's license., • This is a field-based position. The employee is required to set up a home-based office. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #IND123#LI-MI1#LI-Remote As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Oncology - Pennsylvania is from :$160,100-$210,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Job Description Summary We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards. * Strategic Leadership: * * Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio. * Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives. * Innovation & Execution * * Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine. * Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices. * Risk Management & Problem Solving * * Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges. * Thought Leadership & External Engagement * * Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices. * Team Leadership & Development * * Manage and mentor a diverse team of data scientists and people managers across geographies. * Foster career growth through open dialogue, performance management, and strategic development planning. * Operational Excellence * * Ensure GxP compliance in data science programming for clinical trials. * Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency. * Executive Communication * * Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence. Qualifications * Ph.D. in Biostatistics or a Master's Degree in Biostatistics in combination with a Ph.D.in Bioinformatics or related computational sciences. * Deep expertise in statistical methods and their application in clinical trials. * Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics. * Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine). * Proven experience presenting at external forums and influencing regulatory authorities. * Strong people leadership experience in a Data Science setting. * Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred. Eisai Salary Transparency Language: The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

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

Job Locations US ID 2026-1934 Category Medical Affairs Type Regular Full-Time Working closely with the Early Development Lead, the Senior/Executive Director of Clinical Development Oncology will lead clinical execution of targeted protein degradation (TPD) projects for SK Life Science Labs (SKLSL) with a dotted line into its sister company, SK Life Science Inc. (SKLSI). This role will provide strategic leadership across both preclinical and clinical development, ensuring seamless translation of discovery and preclinical findings into early- and late-stage clinical programs, with a particular focus on oncology. The incumbent will provide therapeutic and translational expertise to the development of the current TPD asset(s), while also contributing to portfolio and pipeline strategy. The role includes close partnership with discovery, preclinical, translational, CMC, regulatory, and clinical operations teams to enable efficient progression from IND-enabling activities through clinical proof-of-concept. The position reports to the Chief Scientific Officer of SK Life Science Labs with a dotted line to the Chief Medical Officer of SK Life Science Inc. Preclinical and Translational Development Provide clinical and translational leadership to preclinical oncology programs • Partner closely with discovery and preclinical teams to ensure alignment between biological rationale, nonclinical data packages, and clinical development plans, • Contribute to the design, interpretation, and integration of:, • In vitro and in vivo efficacy models, • PK/PD and biomarker strategies, • Translational endpoints to support dose selection and first-in-human studies, • Provide medical and scientific input into IND-enabling studies, including toxicology, safety pharmacology, and reproductive toxicology, • Support development of translational and biomarker strategies to enable early signal detection and patient selection in oncology trials, • Participate in the development of integrated product development plans and clinical trial strategies informed by preclinical and translational data, • Lead the design and conduct of clinical trials and, as a member of the internal SK Life Science Inc. Clinical Development/Medical Affairs team, provide operational oversight by collaborating with internal and external operations personnel, • Provide medical expertise regarding product development or other scientific issues for drug discovery, development, and senior management decision-making, • Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials, • Participate in pharmacovigilance activities, including SAE evaluation, safety signal assessment, and ongoing analysis of safety data, • Participate in preparation and review of protocols, Investigator Brochures, clinical study reports, safety reports, and clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts, • Interface with regulatory agencies for clinical development programs and regulatory submissions as needed, • Oversee scientific interactions with medical consultants, advisors, and clinical investigators, • Training in and adherence to Good Clinical Practices (GCP); working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as they relate to preclinical and clinical development, • Knowledge of relevant global regulatory guidance impacting preclinical, translational, and clinical development, • Experience interacting with FDA and other global health authorities preferred, • Evidence of ability to work with opinion leaders, • Must be able to work effectively in a team setting, • Communication skills necessary to:, • Represent the Company externally in scientific presentations, conferences and industry groups;, • Present to internal stakeholders; Interact with industry, • M.D. degree with specialized training in oncology preferred, • Practice experience preferable but not required, • Minimum of 10 years of experience in clinical development in the pharmaceutical industry, preferably with oncology compounds or relevant academic research experience, • Ability to multitask, • Adapts to change, • Maintain composure under pressure, • Ability to follow verbal or written instructions and use of effective verbal communications, • Adapts change, adjust change and grasps information quickly, • Examine and observe details

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

Job Description The Clinical Trial Technician position is based within our Clinical Patch Testing department, and works with departmental management and the Principal Investigator in the implementation of clinical trials for patch testing protocols. Job Type: Full Time. Base Hours: 9:00AM - 6:00PM; OR 11:00AM - 8:00PM Monday through Friday MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be able to perform each essential duty satisfactorily, and meet the educational and experience requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES • Review of protocols, test samples, inclusion/exclusion criteria, recruitment requirements and study schedule., • Implementation of all aspects of patch testing clinical trials, including compliance to Standard Operating Procedures, IRB approved protocols, Human Subject Protection, and regulatory requirements., • Perform CRF transcription and data entry into Excel platform., • Peer review trial data as required for accuracy, data integrity, and protocol compliance EDUCATION and/or EXPERIENCE • Must have High School diploma or GED, • Must have at least one year workforce experience COMMUNICATION SKILLS • Must have strong communication and interpersonal skills. OTHER KNOWLEDGE, SKILLS and ABILITIES • Must have initiative and problem solving / analytical skills and keen attention to detail, • Must be organized, flexible, and able to work independently., • Applicant should possess the ability to organize and maintain all clinical trial information for assigned projects and ensure adherence to established policies and procedures., • Must have the ability to work collaboratively and effectively with other clinical team members and physicians. PHYSICAL REQUIREMENTS On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. This position requires the ability to lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials, and use of computer monitor screen frequently. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Summary: This is an individual contributor role that supports the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH, local Regulatory requirements and NS Pharma standard operating procedures. This is a hybrid role that requires employees to come into the office twice a week. Essential Duties and Responsibilities: • Assist in the planning, implementation and management of assigned regional or global clinical studies., • Facilitate CRO./vendor selection process., • Maintain oversight of assigned study vendors (e.g. central labs)., • Perform assigned activities in the selection of clinical sites., • Attend and participate in site visits including pre-study assessments, site initiations, co-monitoring and ad-hoc site visits based on the study’s needs., • Review site visit reports, identify issues and ensure issues are resolved., • Oversight of patient recruitment and development of recruitment strategies and plans., • Track, review, report and present study metrics including enrollment, protocol deviations, issues, risks, data resolution, and other study related metrics., • Support the development of study related documentation (protocol, ICF, CRF, operations manuals, etc.); facilitate internal review of these documents as assigned., • Tracking of clinical data, regulatory documents, and patient, • Assure compliance of investigational sites with SOPs, FDA regulations, ICH guidelines and protocol requirements., • Facilitate internal review of clinical trial agreements and ancillary agreements, • Implement and maintain study-specific training program., • TMF oversight review during study conduct and TMF management during study closeout., • Support creating and maintaining clinical SOPs as part of global QMS., • Perform administrative tasks (e.g. setting-up and facilitating meetings, clinical registrations)., • Thorough understanding of clinical operations including strong knowledge on essential documents as related to the planning, launching, and closing clinical studies, • Must be able to manage and coordinate with the Clinical Lead(s), Study Manager(s), Operations Program Lead and study team members at Headquarters Office in Japan to achieve study objectives and team goals, • Must have the ability to identify and manage/solve study team’s performance issues if they arise with minimal supervision, • Must have demonstrated ability to support the development and management of various aspects of the study operational plans from start-up to close-out., • Must be able to work effectively in a multi-cultural, global team environment and support drug development collaboration with global project teams, Headquarters Office in Japan, external partners and vendors., • Ability to handle multiple tasks and prioritize., • Strong organizational, attention to details, communication and presentation skills., • Team player, flexible, ability to adapt to change, • Ability to interact with Investigators in-person to discuss protocol requirements and study drug., • Bachelor’s Degree in sciences (highly preferred) or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience, • Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials., • Program and project management experience preferred., • Global clinical trial experience is also preferred. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until April 30, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

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