Healthcare & Pharma Careers

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.

This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines.. The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate).. Key Responsibilities Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors.. ·Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA. Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.). Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles.

Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform.. Manage Vaxess’ Document Control, Training, Equipment and Metrology programs.. Maintain an ongoing understanding of and adaptation to the pharmaceutical, biologics, and medical device industries including staying abreast of quality issues within industry and government.. 3 to 5 years in Quality Assurance, in the medical device, biologics and/or pharma industries; or 7+ years working in a GXP Environment.. Experience in pharmaceutical, biological, and combination product development from preclinical drug development through commercialization preferred.

In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting the study.. Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.. Minimum of 2 years of experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years of related experience in the field of clinical research.. Experience with oncology research and clinical trials.. The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing, and compliant study conduct according to all relevant local, federal, and state regulatory and institutional policies and standard operating procedures.

Director of Nursing (DON) Location: Waukegan, Illinois Job Type: Full-Time Summary: The Director of Nursing (DON) is responsible for overseeing the daily operations of the nursing staff with our long-term care facility, ensuring compliance with state and federal regulations, and maintaining high-quality patient care.. Responsibilities: Leadership & Management: Provide direct supervision and leadership to nursing staff, including RNs, LPNs, and CNAs. Develop, implement, and monitor nursing policies, procedures, and protocols to ensure compliance with Illinois Department of Public Health (IDPH), Centers for Medicare & Medicaid Services (CMS), and Joint Commission standards.. Oversee infection control programs, fall prevention initiatives, and quality assurance measures.. Preferred: Master of Science in Nursing (MSN) or Healthcare Administration.. Minimum of 3 years of nursing leadership experience in a hospital, long-term care, assisted living, or skilled nursing facility.

As Sr. Specialist of Regulatory Affairs you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint.. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self.. Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR). Support that QMS requirements are followed and executed consistently from RA perspective. Support business export control (BEC) listing of product for release globally per RA requirements

We are seeking a detail-oriented Home Health Billing Specialist for our home health and home care services.. This role is crucial for optimizing revenue cycle management and supporting the overall financial health of our organization.. Payment Posting: Accurately post payments, adjustments, and denials to patient accounts.. Knowledge of Medicare, Medicaid, and commercial insurance billing processes.. Parx Home Care, an affiliate of Ultimate Care , is a licensed home care provider located in Florida.

Our client, one of Houston's premier research foundations and a global leader in biomedical research and health education, is seeking an RN Clinical Coordinator to conduct research on phase II-IV clinical pharmaceutical trials on an outpatient basis.. Recruit and follow-up with patients participating in clinical trials and outcomes studies.. Conduct phase II-IV clinical pharmaceutical trials in compliance with governmental, company sponsor(s) and IRB regulations.. Associate's degree in nursing (ADN) required; BSN preferred. CCRC to be obtained within 2 years of employment

Director, Regulatory Affairs - Regulatory Operations and North America (Hybrid / Onsite). As the Director, Regulatory Affairs - Regulatory Operations and North America for Advanced Bionics, you will play a critical leadership role in guiding the regulatory team in navigating complex regulatory landscapes and ensuring compliance with all applicable regulations of active implantable medical devices.. Compliance Oversight: Ensure that the company's products comply with regulatory standards (FDA, EU MDR, and other international regulations) throughout the product lifecycle.. In conjunction with Clinical Research, prepare or direct regulatory affairs staff in the generation of applications (i.e., IDE) for conducting clinical investigations.. Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)

The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Velocitys SOPs.. Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocitys SOPs. 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. life science industry AND1 year Clinical Research Coordinator experience

The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Velocitys SOPs.. Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocitys SOPs. 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. life science industry AND1 year Clinical Research Coordinator experience

Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.. This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote.. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.. You will lead the Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs.. The Director of Global Regulatory Affairs will be responsible for developing and executing regulatory strategies for drug development and commercialization ensuring compliance with global regulations and standards across multiple markets.

Pay: We negotiate high salaries using the US Bureau of Labor Statistics.. Benefits & Bonuses: You are eligible for medical, dental, vision insurance benefits, and 401k.. Permanent Employment: Many of Addison's job openings lead to potential permanent employment.. Connections: You connect directly with hiring managers.. Options: You are presented with multiple employment options near your home.

Through the practice of professional nursing the Oncology Clinical Research Nurse (RN) I prioritizes and advocates for the best interest of the patient enrolled on an oncology clinical trial while maintaining the fidelity of the clinical research protocol and compliance with policies, procedures and regulations.. The oncology clinical research nurse works independently under the general supervision of the Clinical Trials Office Management and Leadership and the Principle Investigator for the specific protocol in order to competently support the safe, high quality and compliant conduct of oncology clinical research and ensure the protection of the patient.. The oncology clinical research nurse I is expected to develop and maintain competencies in clinical research nursing in the first year of the position including but not limited to comprehension and compliance with all NYU PCC Clinical Trials Office policies and procedures, NYU OSR and IRB policies and procedures, familiarity and application of Good Clinical Practice (GCP) guidelines and Federal Regulations that govern the conduct of human subjects research.. The oncology clinical research nurse I demonstrates nursing skills as required under NY state and federal regulations for RN licensure and the ability to navigate patients successfully through the course of trial participation within assigned DMG from pre-screening through coming off protocol.. Is flexible to support clinical care needs as the assigned DMG and day off are based on CTO, PCC clinical care needs.

Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is now well funded by a syndicate of life science investors including Sofinnova, Forbion, Perceptive Advisors, Xontogeny, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures.. They will serve as the main point of contact for all regulatory operations and submissions while collaborating with cross-functional teams internally and externally.. Oversee and drive regulatory operations, lead global regulatory submissions INDs/CTAs and NDAs/BLAs, and manage correspondence with agencies like the FDA or EMA.. Ensure the company is in compliance with regulatory standards (e.g. GCP, GMP, and GLP).. Deep and facile understanding of the drug development and global regulations and guidelines, ideally encompassing preclinical through commercialization.

May assist in development of study tools (e.g. tracking forms, questionnaires, chart review forms, etc. Basic Qualifications:ExperienceMinimum two (2) years of experience in public health, healthcare administration, epidemiology, or healthcare-related field OR one (1) year of experience in public health, healthcare administration, epidemiology, or healthcare-related field AND Masters or terminal degree in public health, healthcare administration, epidemiology, or healthcare-related fieldMinimum one (1) year of experience coordinating research projects under specific guidance.. EducationBachelors degree in public health, healthcare administration, epidemiology, or health-related field (ex.. License, Certification, RegistrationN/AAdditional Requirements:Experience with interviewing (by phone and/or in-person) and medical chart review.. Preferred Qualifications:Experience with Infectious Diseases or related areas of researchBilingual SpanishMasters degree in public health, healthcare administration, epidemiology or related field.

The CRN is a member of the clinical research team and assists in the recruitment, compliance and follow-up of patients that are eligible for, or registered to a clinical trial.. Responsible for managing patient standard of care needs as well as participant and protocol needs through application of independent judgment, communication and collaboration with the research patient, patient's family, ancillary/support services, the physician, and the clinical research team.. Provides clinical trial support to ensure patients are offered appropriate clinical trials following Good Clinical Practice standards.. Participates in process improvement activities of the department to ensure patient safety.. Provides clinical research support staff with the documentation needed to determine eligibility and maintain compliance

We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.. The Associate Director of Global Regulatory Affairs & Safety serves as a key point of contact for GRAIL’s UK Responsible Person (UKRP).. Support the legal manufacturer (GRAIL US) in preparation and delivery of required regulatory reports, e.g. annual reports to the MHRA according to regulatory reporting timelines for marketed products in assigned jurisdictions.. Experience in diagnostics or biomarker development with emphasis on oncology is a plus.. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. Our Liver Disease department pioneer’s development of treatments for MASH and ALD and oversee a robust pipeline of projects from early research through late-stage clinical development.. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.. In this role, the International Medical Director helps develop products within the liver disease team working with MASH and/or ALD projects covering clinical drug development from preclinical assessment through Phase 1-4.. The International Medical Director will also assist the Sr. Medical Director in the development and execution of strategic priorities within the therapeutic area, help develop PRO and biomarker strategies.. Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams.