Healthcare & Pharma Careers

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.. Engage in extensive matrix working within GSK, including with senior management, and represent GSK with local regulatory agencies.. Advanced Scientific Degree (PhD, MD, PharmD).. Experience with all phases of the drug development process in regulatory affairs.. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.

Work closely with clinical staff, department heads, and hospital leadership to promote a culture of safety and quality.. Certified Professional in Healthcare of Quality (CPHQ) or similar certification preferred.. Proficiency in quality improvement tools such as NHSN databases as well as Athena and Point Click Care EMR systems.. Knowledge of healthcare regulations, including CMS, CDPH, and LA County.. CIH is an equal opportunity employer.

The Director will collaborate with multidisciplinary teams across Clinical, Research, DMPK, Biometrics, Translational Medicine, Regulatory, and CMC functions to ensure seamless integration of clinical pharmacology insights into development strategies.. Collaborate cross-functionally to integrate pharmacology insights into drug development decisions.. Ph. D. in Pharmacokinetics, Pharmaceutical Sciences, or a related field.. Experience with regulatory filings (NDA/BLA/MAA) and health authority interactions is preferred.. If you are a strategic thinker with a passion for advancing drug development through clinical pharmacology, we encourage you to apply.

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life.. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it.. Providers of compassionate, evidence-based nursing care to Oncology patients and families living with cancer in a healing and innovative environment Nursing at MSKCC. Participate in an individualized training/orientation program geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC. Register now to join Memorial Sloan Kettering's Talent Community to receive inside information on our organization and new job opportunities.

As a Pharmacy Operations Manager with HCA Florida Mercy Hospital you can be a part of an organization that is devoted to giving back!. We are looking for an enthusiastic Pharmacy Operations Manager to help us reach our goals.. The Pharmacy Operations Manager provides managerial support to the Director of Pharmacy and other Pharmacy Department Leadership through day to day departmental leadership and coordination of pharmacy workflow.. HCA Healthcare Co-Founder. We are reviewing applications for our Pharmacy Operations Manager opening.

Dren Bio's pipeline is currently comprised of two distinct drug discovery programs.. The Director will work in close partnership with other key functions such as Clinical Development, Biostatistics, Regulatory Affairs and Translational Science to plan and review study designs, analyze and interpret pharmacokinetic and pharmacodynamic data; apply Model-Informed Drug Development and principles of quantitative clinical pharmacology to ensure optimal drug development and author the clinical pharmacology sections of regulatory documents.. Author and review relevant sections of IND/CTA filings as well as NDA/MAA/BLAsubmissions and other key documents including investigators brochures, clinicalstudy protocols and reports, and regulatory briefing documents.. Analyze, interpret, summarize, and present clinical pharmacology data to internalproject teams, senior management, and to global health authorities.. PhD in pharmaceutical sciences, pharmacology or equivalent professional degree e.g. PharmD.

Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Clinical Research Coordinator II or III position in Chandler.. Title: Clinical Research Coordinator II or III. Minimum (2) years of experience working previously as a Clinical Research Coordinator for late phase clinical trials.. A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.. Experience and training in the conduct of clinical research (specific experience and/or training in clinical research recruitment, including IRB submissions and trial enrollment management)

Company Overview: SystImmune Inc. is a dynamic clinical-stage bio-pharmaceutical company headquartered in Redmond, WA. Our mission is to revolutionize cancer treatment by developing breakthrough-therapeutic multi-specific antibodies and ADCs. With eight assets in ongoing clinical trials and a robust preclinical pipeline, we are committed to advancing innovative therapies from discovery through IND-enabling stages.. The ideal person will be responsible for ensuring that all clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies related to GCP. This role plays a crucial part in maintaining the integrity, reliability, and ethical standards of our clinical research endeavors.. Quality Management System (QMS): Maintain and enhance SystImmune’s QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.. Corrective and Preventive Actions (CAPA): Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.. Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.

Clinical Research Professionals is looking for a Clinical Research Coordinator (preferably with a Nursing license) to manage clinical research protocols.. This individual will work directly with the investigators, and other research staff to ensure protocol visits are being conducted according to ICH GCP guidelines.. Experience and training in conducting clinical trials with knowledge of ICH GCP. Licensed Nurse in Missouri - RN or LVN/LPN (Strongly Preferred). Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing lab specimens

Senior Manager/Associate Director, Regulatory Affairs. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline.. We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company.. Manages the writing, editing, reviewing and compiling of documents needed for regulatory submission activities for US and global assigned products.. Accountable for maintenance and archival of regulatory documents and correspondence.

ThermoFisher Scientific Director, Regulatory Affairs, LED Cambridge, Massachusetts Apply Now When you’re part of the team at Thermo Fisher Scientific, you’ll do important work.. Responsible for providing regulatory mentorship and support to product development teams for strategic design and development, and post-market surveillance and compliance activities.. Writes, coordinates, compiles, and submits Regulatory documents to regulatory agencies including FDA, including International Authorities such as Health Canada, NMPA which includes Pre-submission documents, PMA and/or 510k submissions, CE/MDR Technical Files as well as NMPA partners such as UL, CSA or appropriate notified bodies.. May act or delegate the PPRC and/or official correspondent when vital for IVDR/MDR products.. Validated experience in multiple aspects of RA, including; strategy creation, design control, cGMP/Quality Systems, and import/export requirements.

The Clinical Research Nurse Coordinator is a licensed registered professional nurse who is a clinical expert who provides ethical, evidenced-based, safe and compassionate nursing care.. The Clinical Research Nurse Coordinator focuses on patient safety and high-quality nursing care by identifying and clarifying patient needs, performing clinic related patient care, conducing health education, promoting patient advocacy, coordinating health care services, and evaluating patient outcomes.. Responsible for accurate and timely data collection, documentation, and reporting of all procedures to research coordinator for data entry, data entry as needed.. Coordinate with sponsor, Research Institute, IRB, or FDA as necessary to support studies.. Hematology/oncology nursing experience

We are pioneers in RNtargeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.. The Associate Director / Director of Regulatory Affairs will help develop regulatory strategy and be an active partner in drug development project planning and execution.. Experience with rare disease/orphan drug development and/or cardiovascular or neurology targeted therapeutics is a plus.. This position may be fully remote, however preference will be given to San Diego-based applicants.. Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents

Join to apply for the Medicare/Medicaid HMO Biller (Hospice) role at HospiceMD.. We are a trusted provider of medical billing services and are seeking a dedicated, detail-oriented Medical Biller to join our team.. Job Title: Medical Biller. Process and submit claims for Medicare, Medicaid, and Private/HMO insurance policies.. Stay up to date with current Medicare billing guidelines and insurance regulations.

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.. Performs the incoming quality inspection process to verify that received materials meet quality standards.. Proficiency in Microsoft Office Suite, D365 ERP, and other relevant applications are preferred.. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

The Senior Manager, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM) and bioanalytical (BA) supports and operation for Summit's assets.. Serve as Clinical Pharmacology and DMPK subject matter expert on cross-functional teams in both early- and late-stage projects. Design and outsource in vitro and in vivo ADME studies to characterize the compounds. D., or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with 1+ years of clinical pharmacology industry experience or M.S. with 5+ years of relevant experience. Understanding of clinical pharmacology concepts and conducting clinical pharmacology studies and knowledge of regulatory requirements related to clinical trials (GCP, ICH guidelines), and drug development

Description :Job Responsibilities:Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trialsMaintain source documents and submit case report forms (CRFs) as required for clinical trials.. Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR. Work closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.. Required Qualifications:Education: Associate’s degree plus two years required work experience OR an equivalent combination of relevant post-secondary education and work experience that equals 4 years.. Work Experience: Experience with governing clinical research (CFR, GCP, HIPAA)Experience applying a basic understanding of statutes and guidelines relevant to regulatory affairs in clinical researchExperience with study budgets, contracts and grant applications.. Preferred Qualifications:Work Experience: Prior CRC/Regulatory experience.

This position provides independent coordination of multiple, complex clinical research studies in order to ensure the efficiency and accuracy of clinical studies through all stages as the study progresses and shows vigilance in participant safety, protocol compliance, and data quality.. Participates as needed in the regulatory document submissions as required by the sponsor of the trial, regulatory agencies, and TGH research policy.. CCRC, CCRP or related certification required or must be obtained within 1 year of employment.. Work Locations: TGH Main Campus 1 Tampa General Circle Tampa 33601. Eligible for Remote Work: On Site

The Clinical Research Coodinator I conducts and manages clinical trials in accordance with the study protocol,GCP, and Velocity’s SOPs.. Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs. Coordinate, with supervision, assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.. Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.. Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope

Currently recruiting a Medical Billing Sepcialist to provide Financial Labor Services in support of the Resource Management Division (RMD) at the Brooke Army Medical Center (BAMC) at Joint Base San Antonio, located on Fort Sam Houston, Texas.. DUTIES OF THE MEDICAL BILLING SPECIALIST: Monitors insurance claims and patient accounts in work queues to ensure they are billed and worked within BAMCs guidelines.. Verifies the patient insurance information is correct in Electronic Health Record (EHR) and/or on claim forms.. QUALIFICATIONS OF THE MEDICAL BILLING SPECIALIST: Certified Professional Biller (CPB) or Certified Billing and Coding Specialist (CBCS) or Associate college degree in medical billing/coding or Possess a minimum of 1 years of experience within the past 3 years, in private sector (non-DOD or VA).. Experience must include working with a variety of health insurance companies, Medicare/Medicaid, as well as medical billing and collections.