NewAssociate Medical Director Mitchell MartinAssociate Medical DirectorNew York, NY$225,000–$240,000 / yearBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. Associate Medical Director - New York, NY (Onsite) - Full Time - Mon-Fri 09:00am-05:00pm - $225,000-$240,000 Per Year.
Veterinarian Medical Director National Veterinary AssociatesVeterinarian Medical DirectorBrooklyn, NY$185,000–$250,000 / yearHere’s what to expect when interacting with us: •We’ll always reach out via verified LinkedIn profiles or emails ending in @nva.com•We may also contact you via text message from an identified NVA representative for recruiting-related communication•All job opportunities and applications are hosted on our official careers site: careers.nva.com•There is no cost or confidential information required to apply or be considered for a position If you have any doubts about a communication, feel free to visit our careers page to verify authenticity or email us at hiringhub@nva.com. Animal Kind Veterinary Hospital is seeking a motivated, collaborative, and experienced Medical Director to lead our thriving, nine-doctor companion animal practice in the heart of Park Slope, Brooklyn.
Emergency Medicine Assistant Medical Director in Edison, NJ TeamHealthEmergency Medicine Assistant Medical Director in Edison, NJEdison, NJFull timeThis leadership opportunity is ideal for a board-certified or board-eligible emergency physician who is passionate about clinical excellence, physician engagement, operational performance, and advancing quality patient care in a high-acuity community hospital setting. As assistant medical director, you will partner closely with the medical director and hospital leadership to support the clinical, operational, and strategic success of the emergency department while maintaining an active clinical practice.
Medical Director National Veterinary AssociatesMedical DirectorNew York, NY$175,000–$200,000 / yearHere’s what to expect when interacting with us: •We’ll always reach out via verified LinkedIn profiles or emails ending in @nva.com•We may also contact you via text message from an identified NVA representative for recruiting-related communication•All job opportunities and applications are hosted on our official careers site: careers.nva.com•There is no cost or confidential information required to apply or be considered for a position If you have any doubts about a communication, feel free to visit our careers page to verify authenticity or email us at hiringhub@nva.com. For positions based in Colorado, NVA provides eligible employees with paid sick and safe leave and public health emergency leave in accordance with the requirements of Colorado's Healthy Families and Workplaces Act.
Pediatric Emergency Medicine Medical Director in Summit, NJ TeamHealthPediatric Emergency Medicine Medical Director in Summit, NJSummit, NJ$190–$220 / hourFull timeTeamHealth is seeking a visionary, board-certified pediatric emergency medicine (PEM) physician to serve as medical director at the Overlook Medical Center Pediatric Emergency Department in Summit, New Jersey . With a dedicated pediatric connection to Goryeb Children's Hospital in Morristown, Overlook offers robust support and seamless care to more than 100 pediatric specialists.
Emergency Medicine Assistant Medical Director in Summit, NJ TeamHealthEmergency Medicine Assistant Medical Director in Summit, NJSummit, NJFull timeOverlook Medical Center offers a wide range of services, including the Atlantic Neuroscience Institute, The Gagnon Cardiovascular Institute, and award-winning emergency medicine services. A hospital with a proven track record of clinical excellence, Overlook Medical Center has been ranked by Healthgrades in the top five percent of hospitals in the nation for the treatment of stroke six years in a row.
NewEmergency Medicine Medical Director Inhospital Physicians CorpEmergency Medicine Medical DirectorBayonne, NJPhysical Demands: This physician role requires stamina in fast-paced healthcare: prolonged standing/walking (8-12 hrs/shift); rapid emergency movement (sprints, crowds); lifting/carrying 25-50 lbs equipment; pushing/pulling 100 lbs (beds/carts) with aid; frequent bending/stooping/kneeling for care; constant reaching/fine motor skills (suturing/IVs); occasional climbing/balancing; tolerating stressors (temps, noise, fluids, hazards) during irregular shifts/on-call/infection risksaccommodations for disabilities; varies by setting (clinic/ER). If youre an Emergency Medicine leader ready to take the next step in your career, apply today and join a team committed to delivering outstanding emergency care.
OB/Gyn Hospitalist Medical Director in Westwood, NJ TeamHealthOB/Gyn Hospitalist Medical Director in Westwood, NJWestwood, NJFull timeIdeal for experienced OB/Gyn hospitalists or physicians transitioning from private practice who are seeking a collaborative environment and the opportunity to lead and grow a high-quality program. Known as The Hub of the Pascack Valley, this vibrant suburban community features a walkable downtown, boutique shopping, local restaurants, parks, and top-rated schools.
Physical Therapist -Clinic Director JAG Physical TherapyPhysical Therapist -Clinic DirectorNew Brunswick, NJJAG Physical Therapy, a comprehensive outpatient, orthopedic physical therapy company with 100 facilities throughout Pennsylvania, New Jersey, and New York, is seeking compassionate and motivated individuals to join our winning team! Important Disclaimer Notice: The above statements are only intended to represent the essential job functions and general nature of the work being performed and are not exhaustive of the tasks that an Employee may be required to perform.
Clinical Director - Physical Therapist JAG Physical TherapyClinical Director - Physical TherapistSouth Amboy, NJJAG Physical Therapy, a comprehensive outpatient, orthopedic physical therapy company with 100 facilities throughout Pennsylvania, New Jersey, and New York, is seeking compassionate and motivated individuals to join our winning team! Important Disclaimer Notice: The above statements are only intended to represent the essential job functions and general nature of the work being performed and are not exhaustive of the tasks that an Employee may be required to perform.
Pediatric Emergency Medicine Medical Director in Edison, NJ TeamHealthPediatric Emergency Medicine Medical Director in Edison, NJEdison, NJ$190–$220 / hourFull timeThis leadership role offers the opportunity to guide clinical excellence, mentor physicians, and collaborate with hospital leadership to deliver outstanding pediatric emergency care. Join our dynamic group of physician colleagues at a premiere practice location that serves 20,000 pediatric patients annually!
Medical Director of Quality – Heart & Vascular RWJBarnabas HealthMedical Director of Quality – Heart & VascularWest Orange, NJWorking in close partnership with the VP for Quality, Heart & Vascular, this leader will leverage data and registry insights to drive performance improvement, oversee clinical event reviews and regulatory compliance, and engage physicians and multidisciplinary teams in fostering a culture of accountability, collaboration, and continuous improvement. RWJBarnabas Health, the largest integrated healthcare system in New Jersey, is seeking a Medical Director of Quality – Heart & Vascular to serve as a key clinical leader driving quality, safety, and performance excellence across our system.
NewDiagnostic Medical Sonography Dean/Program Director Swedish Institute IncDiagnostic Medical Sonography Dean/Program Directornew york, NY$150,000–$165,000 / yearDevelops and maintains positive partnerships with the local workforce boards, local economic development agencies, program advisory committees, business and industry, school districts, and other governmental, community, business and educational institutions of the College’s service area to ensure the needs of the area businesses, credit, and non-credit students are met. Plans, administers, manages, and evaluates the Diagnostic Medical Sonography Program and course offerings, in a teaching and learning environment that utilizes face-to-face and digital solutions for courses, textbooks, learning labs, on-line tutoring, and other learning support services.
Adult Congenital Heart Disease (ACHD) Cardiologist – Medical Director RWJBarnabas HealthAdult Congenital Heart Disease (ACHD) Cardiologist – Medical DirectorNewark, NJp>Our partnership with Rutgers University creates the state’s largest academic healthcare system dedicated to providing high-quality patient care, leading-edge research, and world-class health and medical education, further advancing our mission of providing high-quality healthcare in New Jersey. With 12 acute care hospitals, 3 children‘s hospitals, a growing number of our outpatient facilities and physician practices, our healthcare system is committed to providing the highest quality of patient care and health education to the community and region.
NewDirector Medical Monitor JouléDirector Medical MonitorParsippany, NJ$210,000–$335,000 / yearServe as the primary medical contact for investigators and study sites regarding protocol-related medical questions, including subject eligibility and enrollment guidance. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
NewMedical Science Director (Ohio Valley) JouléMedical Science Director (Ohio Valley)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
NewMedical Science Director (New England Region) JouléMedical Science Director (New England Region)Parsippany, NJRemote$200,000–$235,000 / yearA field-based Medical Science Director will support Medical Affairs through compliant scientific exchange, insight gathering, and cross-functional collaboration across oncology and related therapeutic areas (infectious disease, nephrology, acute/critical care). This role partners with HCPs/KOLs, pharmacy leaders, and institutional stakeholders across inpatient/outpatient settings to support medical strategy, evidence generation initiatives, and scientific engagement (congresses, advisory boards, education).
NewMedical Science Director Southern CA JouléMedical Science Director Southern CAParsippany, NJRemote$200,000–$235,000 / yearServe as a scientific resource to healthcare providers (HCPs), key opinion leaders (KOLs), pharmacy stakeholders, and institutional decision-makers across inpatient and outpatient healthcare settings. Support medical affairs activities across oncology, infectious disease, nephrology, acute care, and related therapeutic areas through compliant scientific exchange, insight gathering, and cross-functional collaboration.
NewMedical Science Director (Mid-Atlantic Region) JouléMedical Science Director (Mid-Atlantic Region)Parsippany, NJRemote$200,000–$240,000 / yearThis role serves as a clinical and scientific resource, facilitating evidence-based discussions, gathering medical insights, supporting clinical research initiatives, and collaborating cross-functionally to help inform medical strategy, education, and patient care. The Medical Science Director is a field-based medical affairs professional responsible for building scientific relationships with healthcare providers, key opinion leaders, and healthcare systems across oncology and related specialty therapeutic areas.
NewMedical Science Director (Mountain Plains) JouléMedical Science Director (Mountain Plains)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
NewMedical Science Director Northern CA JouléMedical Science Director Northern CAParsippany, NJRemote$200,000–$235,000 / yearServe as a scientific resource to healthcare providers, key opinion leaders, pharmacy stakeholders, and institutional decision-makers across inpatient and outpatient healthcare settings. Support medical affairs activities across oncology, infectious disease, nephrology, acute care, and related therapeutic areas through compliant scientific exchange, insight gathering, and collaboration.
NewAssociate Director, Medical Writing - Publications JouléAssociate Director, Medical Writing - PublicationsRaritan, NJRemote$160,000–$165,000 / yearProvide expert writing and editing support to ensure timely production of high-quality documents (abstracts, posters, slide presentations, manuscripts, letters to editor, etc.) for publication in medical/scientific journals or presentation at meetings. A PhD, MD, or PharmD with a minimum of 5 years of relevant pharmaceutical/scientific experience is required OR a Master’s (or other advanced degree) with a minimum of 8 years relevant pharmaceutical/scientific experience is required.
NewDirector, Freight Forwarding Sales JobotDirector, Freight Forwarding SalesNew York, NY$150,000–$200,000 / yearThe Director, Freight Forwarding Sales is a hands-on player/coach responsible for leading a regional sales team, driving new business development, growing strategic accounts, and expanding market share across the U.S. This role partners closely with leadership to execute growth strategies, increase revenue, and develop a high-performing sales organization. Company Overview: Our client is a global leader in end-to-end supply chain and logistics solutions, connecting businesses worldwide through integrated transportation, freight forwarding, terminal operations, and technology-driven services.
Assistant Director of Nursing (ADON) Skilled Nursing of BrooklynAssistant Director of Nursing (ADON)Brooklyn, NY$55A Skilled Nursing Facility in Brooklyn, NY is looking to hire an Assistant Director of Nursing (ADON). Assist the Director of Nursing Services (DNS) with management responsibilities and maintaining quality of care.
NewAssistant Director of Nursing (ADON Beth Abraham CenterAssistant Director of Nursing (ADONThe Bronx, NY$130,000–$140,000A vital part of the Bronx community, the facility has a long history of providing a warm and nurturing environment, allowing each resident to get stronger, healthier, and happier. Beth Abraham Center for Rehabilitation and Nursing is a 448-bed rehabilitation and skilled nursing facility with impressive Resident and family satisfaction ratings.
Assistant Director of Nursing (ADON) Skilled Nursing of BronxAssistant Director of Nursing (ADON)The Bronx, NY$130,000Skilled Nursing of Bronx is hiring a Assistant Director of Nursing (ADON) in Bronx, NY. DUTIES: Assist the DNS with management responsibilities and in maintaining the quality of care.
Director of Respiratory Therapy Mitchell MartinDirector of Respiratory TherapyYonkers, NY$165,000–$170,000 / yearBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. • This position involves overseeing the Respiratory Therapy department in a healthcare setting, located in Yonkers, NY.
Clinical Director JAG Physical TherapyClinical DirectorKenilworth, NJJAG Physical Therapy, a comprehensive outpatient, orthopedic physical therapy company with 100 facilities throughout Pennsylvania, New Jersey, and New York, is seeking compassionate and motivated individuals to join our winning team! Important Disclaimer Notice: The above statements are only intended to represent the essential job functions and general nature of the work being performed and are not exhaustive of the tasks that an Employee may be required to perform.
NewDirector of Finance JobotDirector of FinancePearl River, NY$180,000–$220,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. As an auto group with 10+ dealerships across the New York market and over 1000 employees, we have been providing top service and top brands to our customer base for the last 20 years.
Business Development Director Vaco LLCBusiness Development DirectorNew York, NY$75,000–$85,000Duties and responsibilities are to be performed while observing the following Core Tenets: A Team First Approach, aligning with the core tenets: Proud to Wear Jersey, Stay Team Focused, and Assume Positive Intent. Minimum 5 to 7 years’ selling accounting/financial project solutions or comparable client relations experience in audit, tax, and/or public accounting.
NewDirector FP&A - Hospitality Kforce Inc.Director FP&A - HospitalityNew York, NY$160,000–$190,000Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers.
US Sales Director- New Business Sales Vaco LLCUS Sales Director- New Business SalesWoodland Park, NJ$125,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Sr. Director, Enterprise Procurement Vaco LLCSr. Director, Enterprise ProcurementNew York City, NY$180,000–$260,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual's skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Director Field Procurement Operations Vaco LLCDirector Field Procurement OperationsNew York City, NY$180,000–$220,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual's skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Director of IT Vaco LLCDirector of ITNew York City, NY$180,000–$200,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Tax Director Kforce Inc.Tax DirectorParsippany, NJ$175,000–$275,000Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers.
Manager / Director Transaction Services (M&A) Kforce Inc.Manager / Director Transaction Services (M&A)New York, NY$125,000–$200,000Run multiple and challenging Transaction Advisory Services engagements (financial due diligence), participating in transactions related to the acquisitions by private equity investor groups and strategic corporate buyers. Responsibilities Include: Manager/Director Transaction Services will lead buy - side diligence, sell - side diligence, working capital assistance, merger integration and optimization, divestitures and carve outs, and valuation services.
Assistant Director of Nursing Care-OneAssistant Director of NursingParamus, NJ$114,000–$150,000 / yearAlong with the Director of Nursing, promote positive employee relations, strong customer service ethic and commitment to ongoing staff education and training, May exercise direction over the department in the absence of the Director of Nursing. Assist the Director of Nursing with regulatory compliance and ensure effective communication strategies with all levels of nursing staff to promote effective care delivery.
NewOB Hospitalist - Director Opportunity - Belleville OptigyOB Hospitalist - Director Opportunity - BellevilleBelleville, NJHighly relational, able to build strong rapport and positive working relationships with all stakeholders (Hospital leadership, hospitalist teams, nurses, staff physicians, and OBHG corporate staff). Will collaborate with the MMD, MDO or VPCO to ensure the clinical team is delivering a quality program that achieves both OBHG's and the hospital's clinical and operational objectives.
NewOB Hospitalist - Director Opportunity - Plainsboro OptigyOB Hospitalist - Director Opportunity - PlainsboroPlainsboro, NJHighly relational, able to build strong rapport and positive working relationships with all stakeholders (Hospital leadership, hospitalist teams, nurses, staff physicians, and OBHG corporate staff). Will collaborate with the MMD, MDO or VPCO to ensure the clinical team is delivering a quality program that achieves both OBHG's and the hospital's clinical and operational objectives.
NewSenior Director, Clinical Development - Hematology Daiichi Sankyo, Inc.Senior Director, Clinical Development - HematologyBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
NewDirector, Clinical Safety Scientist Daiichi Sankyo, Inc.Director, Clinical Safety ScientistBasking Ridge, NJ$201,840–$302,760 / yearFull timeRisk Management (Signal identification, evaluation, mitigation): Is a key participant in developing and implementing the risk management strategy for assigned products/ TAs; Independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Senior Director, Clinical Safety MD Daiichi Sankyo, Inc.Senior Director, Clinical Safety MDBasking Ridge, NJ$280,350–$467,250 / yearFull timeThe individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
Director, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
Medical Device Sales - Paid Internship Medical Sales CollegeMedical Device Sales - Paid InternshipLawrence, NYProactively research and identify new opportunities via outbound efforts utilizing university relationships, word of mouth, LinkedIn, social media platforms, networking, direct referrals, etc. Shall not misrepresent the nature of the school, facility, programs, expected outcome of training, employment, salary expectations, etc. in any way, either directly or indirectly, implied or omitted.
NewSite Director at New Monmouth Elementary School KinderCare EducationSite Director at New Monmouth Elementary SchoolMiddletown Township, NJ$21.55–$30.20When you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.