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Job Description JOB 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 Companys 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

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

Job Description Job Title: Clinical Research Nurse (Transplant) We are seeking a Clinical Research Nurse specializing in Transplant to join our dynamic team. This role is perfect for a motivated individual with a strong background in clinical research and nursing. You will coordinate and oversee the clinical operations of clinical trials, contributing to the assessment, planning, implementation, and evaluation of patient care in research studies. Responsibilities • Assist the principal investigator in preparing proposed clinical trials by reviewing trial protocol and ensuring appropriate departments are notified., • Ensure all protocol revisions, informed consents, and serious adverse events are submitted to the appropriate IRB in a timely manner., • Act as a liaison between principal investigators and sub-investigators on regulatory issues., • Review studies for feasibility and evaluate potential competition with other protocols., • Recruit and evaluate study patients, schedule appointments, and conduct interviews., • Identify the needs of the patient population served and deliver care specific to those needs., • Review medical records for potential study patients and ensure comprehensive documentation., • Instruct study patients and healthcare providers on clinical trials, treatments, and side effects., • Assist in the consent process and ensure patients understand clinical trials., • Document study patients' medical histories and monitor their progress during trials., • Evaluate and develop study patient education materials., • Plan appropriate care for study patients under the direction of a physician or advanced practice nurse., • Report adverse events to the sponsor and IRB according to established timelines., • Coordinate research activities including scheduling laboratory tests and medical exams., • Perform and oversee clinical duties such as EKGs and blood serum processing., • Maintain accurate and up-to-date records for each patient in a clinical trial., • Prepare for sponsor monitor site visits and resolve any issues found., • Develop case report forms and assist in preparing for publication., • Provide education to all departments and attend research meetings and conferences., • Graduate of an NLN/AACN accredited program in nursing., • 3-5 years of clinical nursing experience., • Transplant RN experience required., • Adherence to the American Nurses Association standards., • Mandatory education on human subjects research., • BSN preferred., • Experience with FDA regulatory, IND reporting, and Microsoft Office Suite. This position offers flexible work hours, typically consisting of four 10-hour days from 7 AM to 6 PM. Employees can choose and coordinate start times with the team. The work environment is fast-paced, high-volume, and high-pressure, requiring efficiency and effectiveness. The team is diverse and supportive, providing a welcoming atmosphere for hardworking individuals. The role requires standing for a minimum of 6 hours a day, with occasional lifting, pushing, and pulling of at least 5 lbs. Job Type & Location This is a Permanent position based out of Hackensack, NJ. Pay and Benefits The pay range for this position is $100000.00 - $120000.00/yr. Hackensack Meridian Healthcare perm benefits package Workplace Type This is a fully onsite position in Hackensack,NJ. Application Deadline This position is anticipated to close on Mar 16, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

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