Healthcare & Pharma Careers

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.

Overview Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for a Supervisor of Clinical Research.. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment.. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance.. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.. Special knowledge of GCP and ICH guidelines preferred Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trials

Providence Health Plan caregivers are not simply valued – they’re invaluable.. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect.. Your voice matters here, because we know that to inspire and retain the best people, we must empower them.. Our are uniquely designed to support you and your family in staying well, growing professionally and achieving financial security.. We take care of you, so you can focus on delivering our of caring for everyone, especially the most vulnerable in our communities.

CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health.. Their primary focus includes multi-site clinical trials, local and large-scale data research, partnerships with industry and academia for technology and innovation research, physician-initiated research, resident-initiated research in teaching facilities, nurse-initiated research, and health sciences student-initiated research.. As a Clinical Research Nurse (CRN) in neurology, you will be vital in managing and executing clinical trials and research projects focused on advancing neurological care.. Patient Care : Providing compassionate and expert care to research participants, performing clinical assessments and procedures within your RN scope of practice, including blood draws, injections, and neurological assessments.. This job requires a highly qualified and experienced Clinical Research Nurse.

Gentiva is seeking a Registered Nurse (RN) Quality Assurance for a nursing job in Austin, Texas.. Job Description & Requirements Specialty: Quality Assurance Discipline: RN Duration: Ongoing Employment Type: Staff Our Company: New Century Hospice, part of the Gentiva family of hospice, home health, palliative, and community care providers, focuses on clinical excellence with compassion and dignity.. Ensure compliance with Medicare Conditions of Participation (CoPs), The Joint Commission (TJC), National Hospice and Palliative Care Organization (NHPCO), and state-specific hospice regulations.. Posted job title: QA Nurse, RN About Gentiva Gentiva is a family of industry-leading hospice, palliative, and home health providers that are passionate about caring for others.. Gentiva’s corporate headquarters is in Atlanta, Georgia, with providers delivering care across the U.S. Benefits Continuing Education Medical benefits 401k retirement plan Vision benefits Discount program Pet insurance Holiday Pay Wellness and fitness programs Mileage reimbursement Dental benefits Employee assistance programs Life insurance

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 Guidelinesand Velocitys SOPs. Create, collect and submit regulatory documents to Sponsors and IRBs as required perprotocol, 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

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.

Position Summary The HMO/Medicare Part A Billing Specialist is responsible for accurate and timely billing and collection of HMO and Medicare Part A claims for long term care and rehabilitation services.. Prepare and submit clean claims to Medicare, including inpatient and outpatient hospital services, skilled nursing facility stays, and home health services.. Qualifications High School Diploma or equivalent required; Associate's Degree in Finance, Healthcare Administration or related field preferred.. Strong understanding of Medicare regulations, coding guidelines (ICD-10, CPT, HCPCS), and billing procedures.. Experience with electronic data interchange (EDI) and claims submission software.

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.

Associate Director, Medical Writing, CTTD Who we are: Agios is a biopharmaceutical company that is fueled by connections.. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. The impact you will make: Agios Pharmaceuticals is searching for a dynamic Associate Director, Medical Writing to join our growing Regulatory Affairs & Medical Writing team.. What you bring: 7+ years as a medical or scientific writer, or equivalent professional or educational experience (e.g., graduate degree in life sciences).. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.

The Clinical Research Nurse carries out the research and works under the general supervision of the principal investigator responsible for the clinical trials.. 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 study.. Reviews study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs.. Recruits and evaluates potential study patients, and works with clinical research coordinator to schedule required appointments and interviews.. Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).

JOB TITLE: Clinical Research Study Coordinator(Contract to hire). As a Clinical Research Study Coordinator , you will play a vital role in managing and administering cutting-edge clinical trials under the guidance of the Principal Investigator.. Accurately enter data into EDC systems, review medical records, and resolve queries per FDA requirements. Minimum of 1.5 years as a Clinical Research Coordinator. Gain hands-on experience in clinical trials that shape the future of medicine.

As a Clinical Research Nurse (CRN) in neurology, you will be vital in managing and executing clinical trials and research projects focused on advancing neurological care.. Patient Care : Providing compassionate and expert care to research participants, performing clinical assessments and procedures within your RN scope of practice, including blood draws, injections, and neurological assessments.. Licenses & Certifications : A current RN license in the state of employment, BLS certification, and a current CCRP or CCRC certification from SOCRA or ACRP are all required. At least 5 years of experience working as a primary research nurse on drug or device trials is preferred. Knowledge : It is crucial to have a thorough understanding of regulatory requirements involving human subjects research, including FDA, OHRP, and GCP guidelines

The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.. Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply.. Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency)Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial supportBasic Qualifications:BS in a Life Sciences or related field.. Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.. RAPS CertificationBiologics experienceVeeva Vault experiencePre-approval experience (phase 1 to phase 3 submission experience)Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.

Snelling Staffing is seeking a Clinical Research Nurse Coordinator.. Will play a key role in the smooth execution of multiple clinical trials through coordination and oversight ensuring compliance with established research protocols and standards.. Additionally, this role will review study candidates’ medical records ensuring study eligibility and obtain proper consent from patients for clinical research studies.. Responsibilities also include performing vital signs, venipuncture/phlebotomy, nasal swabs, and medication dispensing and tracking.. Using good documentation practices, monitor and maintain case reports, forms, and charts that follow established SOP, GCP, and other applicable regulatory requirements.

This role will provide strategic direction and oversight for the management and development of the QMS to support their combination product development and commercialization!. Evolve Quality Systems parameters to meet requirements of various drug and device development stages.. Manage the 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.. Experience in pharmaceutical, biological, and combination product development from preclinical drug development through commercialization preferred.

The Clinical Research Coodinator I conducts and manages clinical trials 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. 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

The Clinical Research Coodinator I conducts and manages clinical trials 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. 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

The Clinical Research Coodinator I conducts and manages clinical trials 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. 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

The Clinical Research Coodinator I conducts and manages clinical trials 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. 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