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Obstetrician-Gynecologist Opportunity New York Health Suffolk County, NY Job Details: Occupation: Physician Specialty: Obstetrics and Gynecology Clinic Location: Suffolk County, NY Employment: Full-Time Opportunity: Private Practice, Outpatient/Inpatient Board Certifications: BE/BC Degree: MD/DO Ideal Candidate: • Experienced Physicians and Residents encouraged to apply About the Role: New York Health is seeking a compassionate and skilled OBGYN to join our thriving multi-specialty practice in Suffolk County, NY. In this role, you’ll be part of a collaborative and patient-centered team, working alongside experienced providers in a supportive, well-resourced clinical environment. This position offers a mix of obstetrics and gynecology, with access to a diverse patient population and a strong referral network—making it an ideal opportunity for both seasoned physicians and those early in their careers. Living in Suffolk County, NY offers a balance of suburban comfort, natural beauty, and coastal charm. Located on the eastern end of Long Island, Suffolk is known for its picturesque beaches, vineyards, and parks, making it ideal for those who enjoy outdoor activities and waterfront living. The county is home to diverse communities, from family-friendly suburbs to the upscale Hamptons, with plenty of dining, shopping, and cultural attractions. Residents also benefit from strong school systems and proximity to New York City, while still enjoying a slower pace of life and a strong sense of community. Recruitment Package: • Top-Tier Compensation: Benefit from highly competitive compensation structures, including sign-on and relocation bonuses. No cap on earning potential. Exact compensation may vary based on skills, experience, and location., • Professional Growth: Enjoy CME reimbursement to further your education and skills., • Comprehensive Benefits: Full employee benefits include: Medical, Dental, Vision, Short-Term and Long-Term Disability, Life, and Accidental Death., • Secure Future: Robust retirement savings plan., • Peace of Mind: We cover your malpractice insurance., • Future Stability: Partnership opportunity offered., • Work-Life Balance: Paid time off, to ensure you maintain a healthy work-life balance., • Community Care: Make a real difference by caring for patients in their local communities., • Career Advancement: Seize leadership opportunities for career growth within our organization., • Innovative Research: Enroll patients in cutting-edge clinical trials., • Academic Excellence: Present and participate in research at prestigious conferences., • Supportive Environment: Join a physician-led and managed organization that values clinical autonomy, work-life balance, and quality patient care while prioritizing your professional development and well-being. Salary Transparency: Exact compensation may vary based on skills, experience, and location. Base Salary Range: between $350,000-$400,000 annually About the Practice and their Mission: New York Health stands as the foremost destination for comprehensive primary and specialized healthcare services. Within our extensive network, a team of exceptional physicians who offer expertise in various fields, including family medicine, internal medicine, nephrology, rheumatology, surgery, urology, obstetrics/gynecology, pain management, and physical therapy. At New York Health, we are unwavering in our commitment to delivering healthcare of the highest caliber, characterized by professionalism, empathy, and individualized attention. Our relentless dedication to providing accessible care to patients and their families has led us to establish conveniently situated offices spanning Long Island and Manhattan, ensuring that quality healthcare is never far from your doorstep. New York Health is a proud partner of OneOncology. OneOncology is a national partnership of leading independent community oncology practices working together to improve the lives of everyone living with cancer with a physician-led, data-driven, technology-powered, and patient-centric model. Through OneOncology, partner practices have shared technology platforms that foster communication, data sharing, and clinical excellence across the network. OneOncology’s non-exclusive clinical trial site management subsidiary, OneR, delivers complex, multi-center clinical trials to affiliated practices. If you would like to apply or learn more about this opportunity, please email your CV to I look forward to speaking with you!

JOB DESCRIPTION Insight Global is seeking a Regulatory Specialist with hands‑on clinical research site experience to join the Clinical Research team of our healthcare client in Hackensack, NJ. This on‑site, 40‑hour‑per‑week contract role will support day‑to‑day site‑level regulatory operations for active clinical trials, ensuring compliance with institutional, federal, and sponsor requirements. On a daily basis, the Regulatory Specialist will prepare, submit, and manage IRB documentation including initial submissions, protocol amendments, continuing reviews, and informed consent updates; maintain complete and audit‑ready regulatory binders; track and manage essential documents within CTMS and document management systems; and serve as a primary regulatory point of contact for PIs, study teams, sponsors, CROs, and IRBs. The role also involves supporting protocol activation and ongoing study maintenance, preparing for and assisting with site audits, inspections, and monitoring visits, addressing regulatory findings through corrective and preventive actions, and managing multiple studies simultaneously in a fast‑paced clinical research environment while ensuring ongoing compliance with FDA regulations, ICH‑GCP guidelines, and institutional policies. MUST‑HAVE REQUIREMENTS • Bachelor’s degree in life sciences or a related field, • Minimum 2–3 years of hands‑on clinical research site regulatory experience, • Direct experience with the IRB lifecycle at the site level, including:, • IRB submissions, • Informed consent documents, • Continuing reviews, • Protocol amendments, • Strong working knowledge of:, • IRB processes, • FDA regulations, • GCP guidelines, • Proficiency with CTMS and regulatory document management systems, • Strong organizational and communication skills, • Proven ability to manage multiple studies and deadlines in a fast‑paced research environment, • On‑site availability required

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.

Job DescriptionJob Title: Pain Management Physician - Partnership Opportunity Salary: Up to $500k with Partnership Opportunity Job Summary: We are seeking a dedicated and skilled Pain Management Physician to join our healthcare team. The ideal candidate will possess a comprehensive understanding of pain management techniques and a commitment to improving patient outcomes. This role involves diagnosing and treating patients with acute and chronic pain conditions, utilizing a variety of interventional and non-interventional approaches. The Pain Management Physician will collaborate with multidisciplinary teams to develop tailored treatment plans that enhance the quality of life for patients. Duties • Conduct thorough patient assessments, including medical history reviews and physical examinations, to determine appropriate pain management strategies., • Develop individualized treatment plans that may include medication management, physical therapy, and interventional procedures such as injections or nerve blocks., • Utilize electronic health record (EHR) systems to document patient interactions, treatment plans, and progress notes in compliance with HIPAA regulations., • Collaborate with other healthcare professionals, including psychiatrists, physiotherapists, and nurses, to ensure comprehensive patient care., • Stay current with advancements in pain management practices through continuous education and participation in clinical research., • Provide education to patients regarding pain management techniques, lifestyle modifications, and self-care strategies., • Monitor patient progress and adjust treatment plans as necessary to achieve optimal outcomes., • Participate in quality improvement initiatives aimed at enhancing patient service and care delivery within the practice. Experience • Board certification in Pain Medicine or a related field is required., • Proven experience in managing acute and chronic pain conditions through both interventional radiology and non-interventional methods., • Familiarity with EHR systems and medical imaging technologies is essential for effective patient documentation and care coordination., • Experience in critical care settings or hospital medicine is preferred, along with knowledge of basic life support protocols., • Strong communication skills are necessary for effective collaboration with multidisciplinary teams and for educating patients about their treatment options., • Previous experience in outpatient settings is advantageous, as well as familiarity with CPT coding for accurate billing practices., • A commitment to ongoing professional development through participation in clinical trials or research related to pain management is highly valued. Join us in making a meaningful impact on the lives of patients suffering from pain by delivering compassionate care through innovative treatment approaches!Job Types: Full-time, Part-time Benefits: • 401(k), • Dental insurance, • Flexible schedule, • Health insurance, • Paid time off

Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes a Difference The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. How You'll Make An Impact • Ability to understand and follow institutional SOPs, • Participate in recruitment and pre-screening events (may be at another location), • Assist with preparation of outreach materials, • Identify potential participants by reviewing medical records, study charts and subject database, • Assist with recruitment of new participants by conducting phone screenings, • Request medical records of potential and current research participants, • Schedule visits with participants, contact with reminders, • Obtain informed consent per Care Access Research SOP, under the direction of the CRC, • Complete visit procedures as required by protocol, under the direction of the CRC, • Collect, process and ship specimens as directed by protocol, under the direction of the CRC, • Record data legibly and enter in real time on paper or e-source documents, • Request study participant payments, • Update all applicable internal trackers and online recruitment systems, • Assist with query resolution, • Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc., • Assist with maintaining all site logs, • Assist with inventory and ordering equipment and supplies, • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials., • Maintain effective relationships with study participants and other care Access Research personnel., • Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management., • Communicate clearly verbally and in writing., • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required, • Bilingual in Spanish required, • Ability and willingness to work independently with minimal supervision, • Ability to learn to work in a fast-paced environment, • Excellent communication skills and a high degree of professionalism with all types of people, • Excellent organizational skills with strong attention to detail, • A working knowledge of medical and research terminology, • A working knowledge of federal regulations, Good Clinical Practices (GCP), • Critical thinker and problem solver, • Friendly, outgoing personality with the ability to maintain a positive attitude under pressure, • Contribute to team and site goals, • Proficiency in Microsoft Office Suite, • High level of self-motivation and energy, • An optimistic, "can do" attitude Certifications/Licenses, Education, and Experience:, • A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist., • Phlebotomy Experience and Proficiency Required, • Some Clinical Research experience preferred, • California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health, • Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners, • Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health, • Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together, • Location: This is an on-site position with regional commute requirements., • Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (<10%)., • Paid Time Off (PTO) and Company Paid Holidays, • 100% Employer paid medical, dental, and vision insurance plan options, • Health Savings Account and Flexible Spending Accounts, • Bi-weekly HSA employer contribution, • Company paid Short-Term Disability and Long-Term Disability We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: Mandatory Employer Disclosures: Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction. Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment. Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment. Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws. Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.

Job Description Location: Paramus, NJ Work Arrangement: Onsite Job Type: Contract A growing pharmaceutical organization is seeking an experienced Biostatistics leader to support clinical development programs from protocol design through final study reporting, regulatory submissions, and post-study analysis. This role will lead key statistical activities across clinical trials and work closely with cross-functional teams, programmers, data management, and external partners to ensure high-quality statistical deliverables and timely execution. Key Responsibilities • Lead statistical support for clinical trials from protocol development through final study report, • Review study protocols and prepare statistical sections, including study design inputs, sample size calculations, analysis methods, and study duration assumptions, • Review CRFs, database design, and edit check specifications to support quality data collection, • Prepare and/or review Statistical Analysis Plans, TFL shells, and variable derivation specifications, • Partner with Statistical Programming and Clinical Data Management to identify and resolve data quality issues impacting key efficacy and safety endpoints, • Provide statistical review and validation support for analysis datasets, outputs, and tables/listings/figures, • Review study reports, manuscripts, and other scientific or regulatory documents with statistical content, • Support regulatory submissions by contributing statistical input and performing additional analyses requested by health authorities, • Monitor timelines and deliverables related to biostatistics and statistical programming, • Oversee CRO statistical activities and review vendor deliverables for quality and compliance, • Collaborate effectively with clinical, regulatory, data management, medical writing, and external vendor teams, • PhD in Statistics or Biostatistics with at least 4 years of pharmaceutical or CRO industry experience, or MS in Statistics/Biostatistics with at least 6 years of relevant industry experience, • Strong SAS programming knowledge, • Deep understanding of ICH guidelines, CDISC standards, and FDA regulatory expectations, • Hands-on experience with:, • Protocol statistical review, • Sample size calculation, • SAP development, • TFL shells and output specifications, • CRF review, • Database design review, • Edit check specifications, • Analysis dataset review and validation, • Regulatory response support, • CRO oversight, • Strong communication, organizational, and time management skills, • Ability to work independently while also leading cross-functional collaboration, • Experience supporting regulatory filings and health authority responses, • Experience contributing to drug development programs, study reports, and publication-related statistical content, • Strong analytical and problem-solving skills, • High attention to detail, • Ability to adapt quickly in a fast-paced clinical development environment, • Composed and effective under pressure

Job DescriptionJOB DESCRIPTION:The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. RESPONSIBILITIES:Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc. Review CRF, database design, and edit check specs Review study quality surveillance plan and monitor study conduct Prepare and/or review SAP, TFL shells and specifications for variable derivation Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents Perform other ad-hoc statistical activities as needed Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming Participates in monitoring CRO activities and reviewing CRO deliverables Other duties as assigned QUALIFICATIONS:Education: Ph.D. or MS in Statistics or Biostatistics Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Excellent knowledge of SAS computer package Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines Excellent organizational skills, time management, and ability to meet established deadlines. Excellent communication and interpersonal skills to effectively interface with others Exceptional interpersonal skills and problem-solving capabilities Ability to work independently and collaboratively Ability to provide leadership for the CRO statisticians and statistical programmers PHYSICAL AND MENTAL REQUIREMENTS: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

Job DescriptionJob Title: Physician Assistant- Partnership Opportunity Salary: Up to $500k with Partnership Opportunity Overview We are seeking a highly skilled and dedicated Physician Assistant to join our multidisciplinary healthcare team. The ideal candidate will possess a comprehensive understanding of clinical assessment, diagnostic evaluation, and patient management across diverse medical settings. This role offers an exciting opportunity to contribute to patient-centered care in a dynamic environment, utilizing advanced clinical skills and a commitment to excellence. The Physician Assistant will collaborate closely with healthcare professionals to deliver high-quality medical services while adhering to regulatory standards and best practices. Responsibilities • Conduct thorough patient assessments, including history taking, physical examinations, and vital signs documentation, ensuring accurate and complete clinical data collection., • Perform diagnostic evaluations utilizing EMR systems such as Epic, Cerner, or eClinicalWorks, integrating laboratory results, imaging reports, and other pertinent data for comprehensive patient care., • Assist in the management of acute and chronic conditions across various specialties including hospital medicine, emergency medicine, ICU, neonatal intensive care (NICU), pediatric (PICU), geriatrics, and primary care., • Administer injections and medications safely following aseptic techniques while maintaining compliance with HIPAA regulations and patient confidentiality standards., • Provide advanced procedures such as suturing, airway management, ventilator support, catheterization (including cardiac catheterization), spinal taps, and gastric lavage under supervision or independently as appropriate., • Support triage processes in urgent care and emergency room settings by prioritizing patient needs based on acuity levels and facilitating timely interventions., • Participate in clinical research trials, data collection efforts, and quality improvement initiatives aimed at enhancing patient outcomes and advancing medical knowledge., • Engage in discharge planning, post-acute care coordination, hospice & palliative medicine services, and health coaching to promote continuity of care beyond the clinical setting., • Maintain accurate medical records using electronic health record (EHR) systems like eClinicalWorks or Cerner; ensure proper coding with ICD-10/ICD-9 codes and CPT coding for billing purposes., • Contribute to infection control protocols, radiation safety procedures during imaging or therapy sessions, and adhere to hospital standards including NCQA guidelines for outpatient clinics., • Demonstrate proficiency in handling complex cases involving infectious disease care, trauma management at Level I/II trauma centers, occupational health issues, addiction counseling, or esthetic laser treatments when applicable. Skills • Extensive experience with EMR systems such as Epic, Cerner, or eClinicalWorks for documentation and data management., • Proficiency in performing clinical procedures including suturing, phlebotomy, IV infusion administration, dialysis support, dermal fillers (nice-to-have), DME management (durable medical equipment), and outpatient clinic workflows., • Strong knowledge of physiology principles relevant to patient assessment and diagnostic evaluation across age groups from neonatal ventilator support to geriatric care., • Demonstrated expertise in acute pain management strategies and medication administration tailored to individual patient needs., • Familiarity with CPT coding practices for billing procedures related to outpatient visits or procedures; understanding of ICD-10/ICD-9 coding standards for diagnoses documentation., • Experience managing complex cases involving ventilator support in ICU settings or neonatal units; Level I/II trauma center experience is highly desirable., • Ability to perform basic life support (BLS) certifications; knowledge of airway management techniques essential for emergency interventions., • Skilled in telehealth platforms for remote consultations; capable of integrating telemedicine into routine practice when necessary., • Excellent communication skills with the ability to educate patients on health coaching topics such as nutrition or family planning while maintaining professionalism within diverse healthcare environments., • Strong organizational skills for managing multiple priorities including intake assessments, discharge planning, clinical trials participation, and data collection efforts aligned with hospital standards. Join our team as we deliver compassionate healthcare through expert clinical practice combined with innovative approaches that improve lives every day!

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 Locations US-NJ-Paramus ID 2026-1967 Category QA Type Regular Full-Time The Associate Director of Quality Assurance-GCP/PVG will report to the VP of Quality. The Director of QA Good Clinical Practices (GCP)/PVG (Pharmacovigilance) will be responsible for all aspects of Quality Assurance GCP activities to ensure quality assurance and compliance of SK Life Science, Inc. (SKLSI) sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, SKLSI Standard Operating Procedures (SOPs), and current industry standards and practices including clinical safety and post marketing pharmacovigilance activities. Activities will generally fall under the following areas: GCP/PVG QA audit program, SKLSI quality systems, and internal/clinical study team support. The Associate Director, QA GCP/PVG will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP/PVG compliance and inspection readiness for all clinical programs. 1. Provide/Handle an oversight on a day-to-day activity for GCP/PVG activities which includes multiple clinical studies, clinical/Post Marketing Requirements/Commitments and EAP programs., 2. Provide supervisory support to GCP/PVG QA as applicable, 3. Work collaboratively with internal Clinical Operations Team to ensure compliance standards are achieved, 4. Manage the GCP Quality interface and support for all Project Teams on assigned projects., 5. Identify and access compliance risk areas and develop and implement risk mitigation measures., 6. Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines, 7. Review and approve Clinical SOPs, 8. Develop and Implement Clinical QA SOPs, 9. Develop and implement detailed audit plans and yearly GCP audit schedules and provide management reports on audit strategy, plans, and findings,, 10. Ensure the timely and effective follow up of all identified or assigned quality issues, 11. Conduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested, 12. Direct or perform CSR audits including systems audits EDC, IRT, PVG and eTMF audits as applicable, 13. Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans, 14. Direct and/or deliver GCP/PVG training for internal staff as applicable, 15. Work closely with Clinical Development, Clinical Operations, Biostats, PVG/Safety and other departments to ensure compliance/inspection readiness, 16. Provide leadership in inspection preparedness to SKLSI clinical sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory government agencies, 17. Host or participate in regulatory inspections related to GCP/PVG, 18. Review and support product quality complaint/AE trends reviews and trends, 19. Support process improvement initiatives; Lead continuous process improvements within Quality., 20. Maintain required knowledge of applicable regulations, guidelines and company standards and procedures. Supervisory Experience: Supervise GCP/PVG team members as applicable. Provide day to day support for the entire QA team, become a key contact in QA team for GCP/PVG related activities communication with VP of QA Provide support in managing the consultant QA as needed BS degree or advance degree in scientific, health care or related discipline • 10+ years of pharmaceutical experience, • Intensive GCP and PVG including process and system auditing background, • Experience with both internal and external audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Strong leadership with demonstrated ability to interface with senior leaders and different levels of organization., • Excellent written/oral communication skills and interpersonal skills to build key networks and business relationships across all levels of the business., • A self-starter and a team-player who thrives in a fast-paced dynamic team environment., • Knowledge of Microsoft Office applications, Adobe, DocuSign, and Veeva., • Experienced working with EDC, IRT, eTMF, and PVG systems

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

Job Locations US-NJ-Paramus ID 2026-1979 Category QA Type Regular Full-Time The Director of Inspection Management/Quality Compliance will report to the VP and Head of Global Quality. The Director, GCP/GVP QA, leads the end-to-end GCP/GVP QA strategy, compliance, and inspection readiness program across the organization. The role oversees a GCP QA team, drives risk-based audits and quality-by-design integration, and manages quality risk processes, metrics, and compliance oversight for GCP and GVP activities. Key compliance responsibilities include monitoring adherence to GCP/GVP regulations, company SOPs, and ICH guidelines; assessing and reporting compliance status across functions; and ensuring timely remediation of findings from audits and inspections. The Director also maintains regulatory intelligence to anticipate changes in global requirements and translates them into actionable QA and compliance standards. Additional responsibilities include leading inspection readiness internally and at clinical sites with CROs, conducting mock inspections and audits with Compliance QA, and acting as the primary moderator for regulatory sponsor inspections. The Director partners with Clinical Development, Operations, Regulatory Affairs, Patient Safety, Data Management, Biostatistics, and external partners to resolve issues and drive continuous improvement. This role aligns QA and compliance strategy with business and regulatory goals, serves as the primary QA point of contact for stakeholders, and ensures clear communication, transparency, and a unified "One Voice for Quality" across the organization. Establishes and maintains the GCP/GVP Inspection Readiness program and supports the development and revision of functional and cross-functional policies and procedures; supports auditing and compliance monitoring of non-clinical and clinical trials in accordance with applicable health authority regulations and guidelines. • Responsible for the overall health of the GCP/GVP Inspection Readiness program, risks anding with cross-functional stakeholders to identify GCP/GVP issues and risks, and creating a risk log and an overall scorecard that can be applied to manage and mitigate risks., • Develops QA GCP/GVP strategy for a team within QA with clear goals and objectives that align with business needs; manages complex issues leveraging benchmarking data and experience, escalates rapidly when needed, and drives resolution., • Partners with Compliance Clinical Operations for Clinical Site Audits; uses the outcomes to inform risk-based decisions and development or refinement of metrics designed to identify potential noncompliance at SK-sponsored clinical trial sites., • Assesses new regulations and guidance to determine if any changes need to be made to internal GCP and GVP processes and/or if any training needs to be developed and delivered., • Oversee and coaches GCP/GVP QA team members through regular individual touchpoints and team meetings., • Develops a GCP/GVP QA playbook that incorporates past experiences and challenges to train team members to identify common clinical trial issues, such as protocol deviations or potential serious breaches, that could impact patient safety and/or data reliability., • Serves as a GCP/GVP change management agent, establishing and maintaining a culture of quality and compliance., • Reviews and approves, as applicable, non-clinical and clinical trial documents, including clinical study protocols and amendments, risk management plans, etc., and regulatory agency submissions, as applicable., • Partners with key stakeholders, including Clinical Operations, Data Management, Safety, other cross functional teams, and QA oversight of the CROs and other critical vendors., • In partnership with functional stakeholders, identifies and manages issues and risks, making sure to document such issues and risks in a risk log so that risk assessment activities are captured, and awareness of key risks is properly disclosed to the relevant parties., • Interprets and applies ICH E6 (R3), Good Clinical Practice (GCP) ICH regulatory guidelines and directives for clinical trials involving human subjects, in line with the goals and principles of ethics in clinical trials, compliance with the study protocol, informed consent, and protection of confidentiality of the test subject, and quality assurance in clinical trial management., • Provides leadership, compliance, and technical expertise., • Demonstrates cross-functional leadership, establishes strong relationships, and leverages influencing skills and expertise to drive change and foster a culture of quality., • Provides guidance, coaching, and development to the QA team., • Bachelor's degree in healthcare or a related field (Master's degree preferred)., • Minimum 15 to 20 Years of solid current pharmaceutical compliance and Inspection Management experience required, • Led end-to-end GCP/GVP inspection readiness programs, including mock inspections, internal audits, and clinical site audits in partnership with Compliance QA and CROs, • Served as primary moderator for regulatory health authority sponsor inspections, triaging first-level questions, managing complex requests, and defending company processes and positions to achieve successful outcomes, • Developed and maintained a risk-based QA strategy and quality-by-design framework across GCP and GVP functions, systems, and activities, • Monitored compliance with GCP, GVP, guidelines, and internal SOPs; tracked and trended key metrics to inform risk-based decisions and drive timely remediation of audit findings, • Collaborated with Clinical Development, Clinical Operations, Regulatory Affairs, Patient Safety, Data Management, and Biostatistics to identify, assess, and mitigate patient safety and data integrity risks, • Built and maintained relationships with functional leaders as the primary QA point of contact, ensuring "One Voice for Quality" in strategic and decision forums, • Delivered training and coaching to cross-functional SMEs on inspection preparation and effective response to regulatory questions, • Managed complex compliance issues with limited data, applying sound judgment to balance business needs, supply, and quality requirements, • Implemented process improvements based on peer company best practices and evolving global regulatory expectations to strengthen inspection readiness, • Drove measurable outcomes by aligning QA and compliance initiatives with business goals and regulatory commitments