NewCenter Clinical Director in Houston, TX making $360K+ Annual Compensation OptigyCenter Clinical Director in Houston, TX making $360K+ Annual CompensationHouston, TX$280,000–$300,000 / yearTo support continued growth, our client is seeking high-caliber primary care physicians and clinical leaders who are motivated by purpose, professional development, and the opportunity to make a meaningful impact in the lives of patients and communities. Our client is a physician-led, mission-driven primary care organization dedicated to transforming healthcare for seniors through high-quality, value-based care.
NewDirector of Nursing Recruiting Source InternationalDirector of NursingKaty, TX$100,000–$125,000 / yearFull timeThis role is responsible for ensuring the delivery of high-quality, compliant, and compassionate home care services while supportingstaff development, performance improvement, and strong interdisciplinary collaboration. Our client is seeking a Director of Nursing and Licensed Administrator to provide visionary clinical leadership and operational oversight across the agency.
Associate Director, Clinical Educator, Sickle Cell Disease (West Zone) - Remote Agios PharmaceuticalsAssociate Director, Clinical Educator, Sickle Cell Disease (West Zone) - RemoteHouston, TXRemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Regional Agios Clinical Educator Manager is a unique leadership opportunity, providing day to day oversight of 5-7 Agios Clinical Educators (ACEs) who interact directly with patients and healthcare professionals.
RN Assistant Director of Nursing Touchstone CommunitiesRN Assistant Director of NursingPorter, TX$90,000–$94,000Th Heights on Valley Ranch 23200 Valley Ranch Parkway Porter, TX 77365 Are you an experienced Registered Nurse (RN) who thrives on leading, mentoring, and driving clinical excellence? This is more than just a job—it’s a chance to grow your career in long-term care leadership while helping us fulfill our mission to Make Lives Better.
Laboratory Director HCA Houston Healthcare WestLaboratory DirectorHouston, TXOur infrastructure includes a fully automated esoteric core laboratory in Fort Lauderdale, a histology and microbiology operation in Largo, Florida, and a network of hospital-based rapid-response laboratories present in four HCA Healthcare divisions in Florida. HCA Healthcare Laboratory Services is a full-service provider of clinical laboratory and anatomic pathology services, providing hospitals, physicians, and clients with timely diagnostic information for patient care.
Director, Biostatistics - Remote Agios PharmaceuticalsDirector, Biostatistics - RemoteHouston, TXRemote$183,000–$275,000 / yearThe current base salary range for this position is expected to be between $183,000 and $275,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Director will serve as the lead statistician for assigned clinical development programs, leading the development and implementation of statistical solutions to support all phases of clinical trials, regulatory filing and facilitating decision-making.
Manager, GMP Quality Assurance - Clinical, QA - Remote Agios PharmaceuticalsManager, GMP Quality Assurance - Clinical, QA - RemoteHouston, TXRemote$110,029–$165,044 / yearThe current base salary range for this position is expected to be between $110,029 and $165,044 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Manager, GMP Quality Assurance, Clinical will be responsible for responsible for supporting and maintaining high quality levels on Agios Drug Substance and Drug Product by Contract Manufacturing Organizations (CMOs).
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteHouston, TXRemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
Associate Director, Medical Review Lead, MSRM - Remote Agios PharmaceuticalsAssociate Director, Medical Review Lead, MSRM - RemoteHouston, TXRemote$185,369–$308,948 / yearThe current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This role provides oversight of medical review for Individual Case Safety Reports (ICSRs) across investigational and marketed products, ensuring medical accuracy, regulatory compliance, and high-quality safety data to support pharmacovigilance and risk management activities.
NewOB Hospitalist - Director Opportunity - The Woodlands OptigyOB Hospitalist - Director Opportunity - The WoodlandsThe Woodlands, TXHighly 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 - Houston OptigyOB Hospitalist - Director Opportunity - HoustonHouston, TXHighly 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 - Cypress OptigyOB Hospitalist - Director Opportunity - CypressCypress, TXHighly 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.
Hospital Laboratory Director HCA Houston Healthcare NorthwestHospital Laboratory DirectorHouston, TXOur infrastructure includes a fully automated esoteric core laboratory in Fort Lauderdale, a histology and microbiology operation in Largo, Florida, and a network of hospital-based rapid-response laboratories present in four HCA Healthcare divisions in Florida. HCA Healthcare Laboratory Services is a full-service provider of clinical laboratory and anatomic pathology services, providing hospitals, physicians, and clients with timely diagnostic information for patient care.
NewSenior Director, Client Partner EPAM SystemsSenior Director, Client PartnerHouston, TXIn this role, you will act as the primary point of contact for clients, delivery teams, technology practices and consulting teams within the Life Sciences Business Unit, developing account strategies, architecting delivery approaches, building successful relationships and owning business results. • Shape solutions that bridge strategy and plans to real-world execution, properly scoping and pricing engagements with delivery team counterparts, establishing optimal operating models and project team organization, and leading the transition from the sales process to the delivery phase.
Associate Director, Scientific Communications & Publications - Remote Agios PharmaceuticalsAssociate Director, Scientific Communications & Publications - RemoteHouston, TXRemote$153,000–$230,000 / yearOperating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Associate Director, Forecasting & Performance Analytics, Commercial Operations & Analytics - Remote Agios PharmaceuticalsAssociate Director, Forecasting & Performance Analytics, Commercial Operations & Analytics - RemoteHouston, TXRemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Build, maintain, and evolve operational, unit-based forecasts across the portfolio – demand, revenue, and patient-based models – including scenario planning and risk and opportunity assessments for multiple launches and in-line products.
Engineering Director - Tax Product Development bdo consultingEngineering Director - Tax Product DevelopmentHouston, TX$210,000–$325,000 / yearExtensive knowledge of cloud platforms (Azure, AWS GCP), AI platforms like OpenAI, Anthropic, DevOps practices, CI/CD pipelines, containerization (Docker, Kubernetes), and database technologies (SQL, NoSQL), preferred. The Engineering Director, Product Technical Lead is responsible for product engineering for cloud-based solutions for a Tax service line, including Partnership, Corporate, Indirect, and Strategic Tax Services within BDO.
Interim Director of Acute Inpatient Rehabilitation Signet HealthInterim Director of Acute Inpatient RehabilitationHouston, TXSignet Healths Acute Rehabilitation Division is growing and recruiting seasoned Interim Acute Rehabilitation Directors to manage hospital-based inpatient rehab programs. As an Interim Acute Rehabilitation Director, you will be responsible for the onsite daily management needs of the Signet Health Client hospital contractual relationship and the supervision of patient care for the unit.
Director of Acute Inpatient Rehabilitation Signet HealthDirector of Acute Inpatient RehabilitationHouston, TXAbility to utilize metrics (CMI, Functional Gain, Length of Stay, Discharge Destination)from tools like UDSMR/PEM reports to benchmark performance, drive quality improvement, and manage productivity. Signet Healths Acute Rehabilitation Division is growing and recruiting seasoned Acute Rehabilitation Director to manage a hospital-based inpatient rehab program in Texas.
Associate Director, Global Safety Lead - Remote Agios PharmaceuticalsAssociate Director, Global Safety Lead - RemoteHouston, TXRemote$185,369–$308,948 / yearo The current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. • Proactively assesses and evaluates the clinical implications of safety data from all sources in order to understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing settings as appropriate.
NewManaging Principal / Senior Director, Data Analytics Consulting EPAM SystemsManaging Principal / Senior Director, Data Analytics ConsultingHouston, TXThis is a high-impact, client-facing role designed for an ambitious professional with deep technical expertise in AI & Data, proven consulting acumen, and a track record of driving transformational outcomes for enterprise clients. • Serve as a trusted strategic advisor to senior executives (VP, SVP, C-suite) on AI enablement, data-driven transformation, and operational efficiency for Fortune 500/50 clients.
NewRegistered Nurse (RN) - Home Health - $70K-95K per year Elara CaringRegistered Nurse (RN) - Home Health - $70K-95K per yearHighlands, TX$70,000–$95,000 / yearAssesses assigned case load of home health care patients and families to identify the physical, psychosocial, and environmental needs of patients as evidenced by documentation, clinical records, Interdisciplinary Team reports, after hours reports, and on-site evaluations. As a Registered Nurse Home Health, you’ll contribute to our success in the following ways: Ensures that all activities performed align with the vision of Elara Caring’s board of directors, executive team, and the leadership of the Home Health team.
NewTravel Physical Therapist - $1,939 per week HCS 247Travel Physical Therapist - $1,939 per weekHouston, TXOur clinical coverage includes Registered Nurse specialties such as ER, ICU, Med-Surg, Telemetry, Step-Down, OR, PACU, L&D, Mother/Baby, NICU, Cath Lab, Endoscopy, and more along with a full range of allied and imaging professionals, including Respiratory Therapists, Surgical Technicians, X-Ray Techs, CT Techs, MRI Techs, Interventional Radiology (IR) Techs, Cath Lab Techs, Ultrasound/Sonographers, Mammography Techs, and Nuclear Medicine Techs. HCS 24/7 is a national healthcare staffing organization specializing in the placement of Registered Nurses and Allied health professionals across acute care and other clinical settings.
NewHome Health Occupational Therapist - $85K-120K per year Elara CaringHome Health Occupational Therapist - $85K-120K per yearStafford, TX$85,000–$120,000 / yearEvery day our compassionate teams deliver high-quality care to more than 60,000 patients nationwide, helping them live safely and independently in the place they love most. At Elara Caring, every team member plays an important role in delivering compassionate care that helps patients live safely and comfortably at home.
NewTravel CVOR RN - $2,339 per week HCS 247Travel CVOR RN - $2,339 per weekHouston, TXOur clinical coverage includes Registered Nurse specialties such as ER, ICU, Med-Surg, Telemetry, Step-Down, OR, PACU, L&D, Mother/Baby, NICU, Cath Lab, Endoscopy, and more along with a full range of allied and imaging professionals, including Respiratory Therapists, Surgical Technicians, X-Ray Techs, CT Techs, MRI Techs, Interventional Radiology (IR) Techs, Cath Lab Techs, Ultrasound/Sonographers, Mammography Techs, and Nuclear Medicine Techs. HCS 24/7 is a national healthcare staffing organization specializing in the placement of Registered Nurses and Allied health professionals across acute care and other clinical settings.
Clinical Director - Academy Social Skills ABCClinical Director - Academy Social SkillsKaty, TexasUnique Perks: First Stop Virtual Health for you and up to 7 household members, CALM membership for you and your family, Door Dash Pass, MilkStork access to ship home breast milk while traveling, a SNOO smart sleeper for new parents, and more. Monthly Performance Bonuses: Bonuses are uncapped and start at just 26 hours of treatment delivery per week, meaning you’ll be rewarded for your impact without waiting months to qualify.
Physician (Clinical Director) - Direct Hire U.S. Department of JusticePhysician (Clinical Director) - Direct HireTX$145,000–$350,000 / yearResponsible for clinical care provided at the institution, including reviewing applications and credentials for membership to the medical staff; interviewing prospective physicians and mid-level providers; implementing and monitoring in-house Continuing Professional Education (CPE) training; maintaining the quality of health records; supervising Physicians (if applicable), and evaluating patient care through an ongoing quality assurance program that identifies problems and their resolution. If you are on active duty and expect to be discharged or released from active duty service within 120 days, you may submit a Certificate of Release or Discharge from Active Duty from the appropriate Branch Personnel Office containing the following information: (1) the military service dates including the expected discharge or release date; (2) and the character of service (must be an honorable or general discharge); and (3) any qualifying service/campaign/expeditionary medals.
Clinical Director United Surgical Partners International Inc (USPI)Clinical DirectorCypress, TXFull timeJob Summary: The Clinical Director is responsible for overseeing and developing the ambulatory surgical center’s clinical departments through key tasks such as hiring, evaluating, mentoring, scheduling, and supervision. Additionally, the clinical director needs to possess great organizational and program development skills, as well as experience in basic computer software such as the Microsoft Office suite.
BCBA Clinical Director ABA Therapy for AutismBCBA Clinical DirectorKaty, TexasUnique Perks: First Stop Virtual Health for you and up to 7 household members, CALM membership for you and your family, Door Dash Pass, MilkStork access to ship home breast milk while traveling, a SNOO smart sleeper for new parents, and more. Education and Support Continuing Education: A minimum of 10+ free CEUs per year in-house, extra funds to attend additional training courses, and 2 paid days off to use for CEU events.
In-Home BCBA Clinical Director ABA Therapy for AutismIn-Home BCBA Clinical DirectorSouth Houston, TexasUnique Perks: First Stop Virtual Health for you and up to 7 household members, CALM membership for you and your family, Door Dash Pass, MilkStork access to ship home breast milk while traveling, a SNOO smart sleeper for new parents, and more. Education and Support Continuing Education: A minimum of 10+ free CEUs per year in-house, extra funds to attend additional training courses, and 2 paid days off to use for CEU events.
Managing Clinical Director - Licensed Psychologist - Bilingual (Spanish) - Spring, TX Next STEPS WorldwideManaging Clinical Director - Licensed Psychologist - Bilingual (Spanish) - Spring, TXSpring, TX$167,000–$192,000 / yearAt Next STEPS Worldwide , we’re redefining outpatient care across Texas—and we’re looking for a passionate Managing Clinical Director (Licensed Psychologist) - Bilingual (Spanish) to lead our team in Spring . As Managing Clinical Director, you’ll oversee daily clinic operations, lead a multidisciplinary team, and drive initiatives that ensure top-tier client care and clinic success.
Managing Clinical Director – Licensed Psychologist - Bilingual (Spanish) - Houston, TX Next STEPS WorldwideManaging Clinical Director – Licensed Psychologist - Bilingual (Spanish) - Houston, TXHouston, TX$167,000–$192,000 / yearAt Next STEPS Worldwide , we’re redefining outpatient care across Texas—and we’re looking for a passionate Managing Clinical Director (Licensed Psychologist) - Bilingual (Spanish) to lead our team in Houston . As Managing Clinical Director, you’ll oversee daily clinic operations, lead a multidisciplinary team, and drive initiatives that ensure top-tier client care and clinic success.
NewAssociate Market Clinical Director ChenMed Family of CompaniesAssociate Market Clinical DirectorHouston, TXThe rest of your time will focus on leadership: mentoring Clinical Directors, fostering a strong clinical-operations partnership, and helping cultivate a positive, thriving culture. As an Associate Market Clinical Director, youll lead and mentor Clinical Directors across multiple centers within your market.
Clinical Director Board Certified Behavior Analyst/ BCBA BlueSprig IncClinical Director Board Certified Behavior Analyst/ BCBAStafford, TXAs part of that, we work hard to maintain our Great Place To Work status so that everyone is rewarded fairly and earns opportunities for bringing their whole and best selves every day, to allow for the fulfillment of our mission to change the world for children with autism. Balanced Leadership RoleStay connected to clinical work while leading at a higher level.
Occupational Therapy Assistant OTA - Clinical Director Pima Medical InstituteOccupational Therapy Assistant OTA - Clinical DirectorHouston, TX$78,030–$97,535 / yearIn this role, you will lead and coordinate the clinical (fieldwork) education and instruction of OTA students-managing clinical site relationships, ensuring effective fieldwork experiences, and supporting students from initial orientation through program completion. Site Visitations: Visit clinical sites regularly to review, observe, and evaluate student clinical performance and progress; collaborate with site instructors to ensure effective clinical education.
Clinical Director - Board Certified Behavior Analyst/ BCBA BlueSprigClinical Director - Board Certified Behavior Analyst/ BCBAStafford, TexasAs part of that, we work hard to maintain our Great Place To Work ® status so that everyone is rewarded fairly and earns opportunities for bringing their whole and best selves every day, to allow for the fulfillment of our mission to change the world for children with autism. For the safety and security of our clients, this position requires a background check, which may include, but is not limited to, criminal history and driving record.
Assistant Clinical Director CYE GA LLCAssistant Clinical DirectorHouston, TXThe ideal candidate is highly organized with excellent written and verbal communication skills and a friendly demeanor. In this role, you will provide support to our office staff, ensuring they have all the information and resources they need to perform their best.
NewRN Clinical Director Hospice Altus HospiceRN Clinical Director HospiceKingwood, Texas$90,000–$105,000 / yearFull timeCollaborating closely with your Program Director, Hospice Physician, and Community Liaisons, you'll orchestrate office excellence, foster growth in patient numbers, and guarantee adherence to Federal, State, ACHC, and Altus Hospice guidelines. A minimum of 3 years experience as a nurse, including 1 year of full time experience in providing direct patient care in a hospice, home health or oncology setting, and 1 year of supervisory experience in hospice or home health care preferred.
Center Clinical Director in Houston, TX making $360K+ Annual Compensation Optigy GroupCenter Clinical Director in Houston, TX making $360K+ Annual CompensationHouston, TEXAS$280,000–$300,000 / yearTo support continued growth, our client is seeking high-caliber primary care physicians and clinical leaders who are motivated by purpose, professional development, and the opportunity to make a meaningful impact in the lives of patients and communities. Our client is a physician-led, mission-driven primary care organization dedicated to transforming healthcare for seniors through high-quality, value-based care.
NewBecome a Center Clinical Director at ChenMed – Lead, Innovate, Transform Healthcare ChenMed Family of CompaniesBecome a Center Clinical Director at ChenMed – Lead, Innovate, Transform HealthcareHouston, TXLeadership: Guide and coach physicians and clinicians, deliver training, and develop clinical training materials. Experience: Minimum of 3 years post-residency, with at least 2 years in a clinical leadership role.
DCS (Director of Clinical Services) Hospice (23344) Cantex Continuing Care Network LLCDCS (Director of Clinical Services) Hospice (23344)Stafford, TXSupervises and provides direction to subordinates, in an effort to ensure quality compliance with Plan of Care and assessment and reassessment of patients needs and continuity of services by appropriate health care personnel. Promotes and educates regarding the concepts of infection control and universal precautions in coordinating/performing patient care activities to prevent contamination and transmission of disease.
Director of Clinical Services (23717) Cantex Continuing Care Network LLCDirector of Clinical Services (23717)Stafford, TXSupervises and provides direction to subordinates, in an effort to ensure quality compliance with Plan of Care and assessment and reassessment of patients needs and continuity of services by appropriate health care personnel. Promotes and educates regarding the concepts of infection control and universal precautions in coordinating/performing patient care activities to prevent contamination and transmission of disease.
Director of Clinical Services (23716) Cantex Continuing Care Network LLCDirector of Clinical Services (23716)TXSupervises and provides direction to subordinates, in an effort to ensure quality compliance with Plan of Care and assessment and reassessment of patients needs and continuity of services by appropriate health care personnel. Promotes and educates regarding the concepts of infection control and universal precautions in coordinating/performing patient care activities to prevent contamination and transmission of disease.
Occupational Therapy Assistant (OTA) - Clinical Director Pima Medical Institute Current OpeningsOccupational Therapy Assistant (OTA) - Clinical DirectorHouston, TexasIn this role, you will lead and coordinate the clinical (fieldwork) education and instruction of OTA students—managing clinical site relationships, ensuring effective fieldwork experiences, and supporting students from initial orientation through program completion. Site Visitations: Visit clinical sites regularly to review, observe, and evaluate student clinical performance and progress; collaborate with site instructors to ensure effective clinical education.
Area Clinical Director (South Central) RxSight IncArea Clinical Director (South Central)Houston, TX$150,000–$200,000 / year10+ years of experience in ophthalmic clinical field roles, with at least 4 years in a leadership capacity; 3-5 years of clinical leadership experience. ESSENTIAL DUTIES AND RESPONSIBILITIES: Partner with the Area Sales Director to align clinical strategy and resource deployment to the area's business direction and account priorities, ensuring clinical execution advances commercial goals.
BCBA Clinical Director Success On The SpectrumBCBA Clinical Director$90,000–$105,000Our model combines the most effective methods of Applied Behavior Analysis (ABA) science, a fun environment, community outings, safety, and high parent involvement in children who have ASD. Our goal is to teach valuable life skills that help our clients become productive and fulfilled adults, ultimately increasing the overall quality of life.
Board Certified Behavior Analyst / Assistant Clinical Director HARMONY ABA CENTERS LLCBoard Certified Behavior Analyst / Assistant Clinical Directorkaty, TX$85,000–$90,000 / weekIf you are ready to lead a dynamic clinical team and make a meaningful impact in the lives of children and their families, we invite you to apply today! Through a focus on family involvement, collaboration, and community inclusion, we create a nurturing environment where every child can thrive and reach their fullest potential.
Clinical Resource Director HCA Healthcare IncClinical Resource DirectorSugar Land, TXThe Clinical Resource Director has a broad enterprise and segment influence and will need to build strategic alliances with Hospital Leadership, Physicians and Supply Chain to execute successfully the clinical supply expense plan. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses.
Clinical Director FYZICAL Therapy & Balance CentersClinical DirectorHumble, TexasFYZICAL Therapy & Balance Centers in Houston, TX is seeking a motivated Physical Therapist (DPT) to help launch and grow a new outpatient clinic. Whether you’re an experienced PT or an early-career clinician ready to be part of something new, this role is flexible based on the right candidate.
Director, Clinical Research Regulatory Affairs University of Texas MD Anderson Cancer CenterDirector, Clinical Research Regulatory AffairsHouston, TXRemoteSuccessful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience Completion of both programs can be substituted for a maximum of two years of supervisory or management experience. Preferred: Demonstrated experience preparing and managing INDs and/or IDEs; familiarity with companion diagnostics and combination products is a plus, and an in-depth knowledge of FDA regulations, ICH guidelines, and GCP requirements, and an experience with EMA submissions.