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The professional registered nurse is knowledgeable of current trends in healthcare including but not limited to advances in technology, pharmacology, treatment care modalities, quality and patient safety.. The professional registered nurse serves as a patient and family advocate while facilitating a cooperative and collaborative environment among all health care providers.. Performs procedures (including IV therapy) and treatments (including nutrition) using nursing knowledge and judgment, according to established unit/practice area guidelines and professional standards. Knowledge and application of the nursing process to implement a nu r sing plan of care.. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
The professional registered nurse is knowledgeable of current trends in healthcare including but not limited to advances in technology, pharmacology, treatment care modalities, quality and patient safety.. The professional registered nurse serves as a patient and family advocate while facilitating a cooperative and collaborative environment among all health care providers.. The professional registered nurse is responsible for the planning, delivery and management of patient/family centered care utilizing the nursing process and adhering to the standards of nursing practice embedded in research, evidence based practice and/or best practices.. Tufts Medicine is a leading integrated health system bringing together the best of academic and community healthcare to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts.. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
The Regulatory Affairs Manager is responsible for supporting the regulatory function and its activities, the. development of regulatory strategy focused on the use of NGS technology for companion diagnostic. Master's Degree in science, law, health policy, regulatory affairs or engineering and 3+ years of. Doctorate Degree in science, law, health policy, regulatory affairs or engineering. Industry experience in oncology, NGS, IVD, CDx, CAP/CLIA, and/or regulatory
As the Development lead, the Senior Director will work closely with senior leaders from Commercial, Technical Operations, Medical, and Corporate Strategy to ensure alignment on key objectives and the seamless integration of R&D strategies across the drug development process.. Provide strategic oversight for R&D activities, including drug discovery, preclinical research, and clinical development, ensuring they align with the company’s long-term objectives.. Serve as the primary conduit between R&D and other key functions (Commercial, Technical Operations, Medical, Corporate Strategy) to ensure consistent communication and alignment on program direction and execution.. Deep knowledge of drug discovery and development processes, including preclinical research, clinical development, regulatory strategies, and lifecycle management as well as pharmacology, toxicology, formulation science, and biostatistics.. Strong understanding of regulatory pathways, including IND/CTA submissions, clinical trial design, and global requirements.
The successful candidate will be responsible for leading Addiction Psychiatry at Tufts Medical Center (TMC) and across the Tufts Medicine healthcare system in collaboration with the Department of Medicine, and through partnerships with the Tufts Medicine Integrated Network (TMIN), Lowell General Hospital and MelroseWakefield Health.. Our incumbent Chief will also have the opportunity to continue existing and develop new clinical research opportunities in addiction psychiatry at TMC and across Tufts Medicine.. This role will oversee a multidisciplinary team, including non-clinician recovery coaches, to expand addiction care across multiple settings such as the emergency department, inpatient services, TMC outpatient clinics, and TMIN practices.. The Chief of Addiction Psychiatry will address the high prevalence of substance use disorders within TMIN primary care settings by improving access to team-based addiction care and supporting the performance of Medicaid ACO, Medicare, and commercial risk contracts.. Possess an MD, or equivalent, and eligible to obtain a medical license in the Commonwealth of Massachusetts
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries.. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.. University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences. Excellent understanding of the drug development process, systemic drug and biologics experience preferred. Excellent knowledge of international ICH/GCP guidelines, basic knowledge of GMP/GDP
Lead early interactions (Pre-IND) with global health authorities (FDA, EMA, PMDA) to secure alignment on preclinical packages, first-in-human protocols, and biomarker strategies for CNS therapies.. Design integrated early development strategic plans that bridge preclinical data (toxicology, pharmacology, CMC) with Phase I/II clinical objectives, addressing unique psychiatry/neurology challenges (e.g., blood-brain barrier delivery, placebo response mitigation).. Support Phase II PoC & Phase III Readiness; Develop Phase II protocols with Go/No-Go criteria and strategies to de-risk psychiatry/neurology programs; Prepare Phase III regulatory groundwork, including End-of-Phase II (EOP2) meeting packages, safety database planning, and alignment with ICH guidelines for multi-regional trials.. Global Submission & Portfolio Strategy; Oversee NDA/MAA submission roadmaps, ensuring late-phase clinical, nonclinical and CMC data packages meet regional requirements for CNS therapies; Advise on portfolio prioritization, balancing early-stage innovation (Pre-IND/IND) with late-phase assets to optimize resource allocation and regulatory success.. Proficiency with publishing and document management tools (e.g., Veeva, Smartsheet, office timeline pro)
WHOOP is seeking a Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory affairs for Medical Device Software in the US. In this role, you will work with the WHOOP Medical Device Team to act as a champion of U.S. Regulatory activities throughout the medical device lifecycle.. As a Regulatory Affairs Manager, you will be responsible for various regulatory & quality functions, such as leading regulatory submissions, implementation of quality system processes, collaborating with the WHOOP Medical Device Team throughout the product development process, and ensuring compliance with the Quality Management System (QMS).. Implement post-market surveillance, including complaint handling, adverse event reporting (MDR), and field actions. Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience. Nice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health or Mobile Medical Applications
Position Summary: The Massachusetts Senior Medicare Patrol (SMP) Program is part of a national initiative to reach, educate, and counsel Medicare and Medicaid beneficiaries, family members, and caregivers across the Commonwealth to protect, detect, and report healthcare errors, fraud, and abuse.. Review all resolved cases "ready to be closed" with respective Complex Interaction Counselor/s to ensure that the explanation re: monetary savings, such as cost avoidance and/or expected recoveries to Medicare and/or Medicaid or actual savings to the beneficiary is precisely documented with supporting documentation accurately uploaded to SIRS. Close Complex Interaction Cases in consultation with the MA SMP Program Director for Quality Assurance.. Consult with the MA SMP Program Director weekly, or as needed, regarding cases that need to be referred to ACL for the OIG, Office of the Attorney General, Centers for Medicare and Medicaid Services, Quality Improvement Organization, or other investigative and/or law enforcement entities, advocacy organizations such as Legal Services, Health Law Advocates, etc.. Plan and convene regular bi-weekly meetings with SMP Volunteer Complex Interaction Counselor/s and the MA SMP Program Director to discuss and strategize possible solutions related to the healthcare errors, fraud, and abuse allegations brought to the attention of the MA SMP Program.. Maintain up-to-date documentation in SIRS database and in client case files to ensure accurate statistical records, and compliance with reporting requirements from the Administration for Community Living (ACL), Office of the Inspector General (OIG) and AgeSpan.
Join our team at The Brentwood Rehabilitation and Healthcare Center as an MDS Coordinator.. Fulltime or part time positionability to split time between The Brentwood and sister facility, Blueberry Hill in Beverly MA (on site roles). Supervise MDS data entry and transmission.. Primary series of the COVID-19 vaccine required. Graduate of an accredited School of Nursing (RN, BSN, or LPN)
The Biomarker Development (BMD) group at the Novartis Institutes for BioMedical Research (NIBR) is seeking a Senior Expert Imaging to join our Clinical Imaging team and actively provide strategic, scientific, technical and operational leadership on the optimal use of imaging in drug development.. Act as an internal expert in PET/SPECT and Molecular Imaging with focus on clinical trials. Drive molecular imaging and ligand development from late pre-clinic to clinic. Experience in clinical Radioligand/Radiopharmaceutical Therapy (RLT/RPT) is a plus. Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Research, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Decision Making, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy- Leadership, Influence, Laboratory, Lifesciences, Machine Learning (Ml), Medical Research, Mentorship {+ 11 more}
Role Description This is a full-time on-site role for a Regulatory Affairs Specialist located in Torrance, CA. The Regulatory Affairs Specialist will be responsible for regulatory documentation, compliance, requirements, submissions, and overall regulatory affairs activities.. Qualifications Regulatory Documentation and Regulatory Compliance skills. Understanding of Regulatory Requirements and Regulatory Affairs. Comfortable working directly for regulatory agencies, including the Food and Drug Administration (FDA), DEA, and Boards of Pharmacies. Bachelor's degree in a relevant field (pharmacy, biology, chemistry, etc.)
Remote Position Type On-Site Work Only. Published Description: Job Title: Registered Nurse (RN) - ICU About Aequor: Established in 1998, Aequor is a premier healthcare and education staffing company, committed to connecting skilled professionals with rewarding career opportunities.. Maintain accurate and detailed documentation in electronic health records (EHR), ensuring all patient interactions, medications, and procedures are properly recorded.. Proficiency in electronic health records (EHR) systems.. Benefits: Tax-free housing and meal stipend (depending on the location of your assignment).
Job DescriptionAbout the JobThe Regulatory Affairs Manager is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products.. The position actively supports the development of regulatory strategy focused on the use of NGS technology for companion diagnostic assays for cancer patients.. Master's Degree in science, law, health policy, regulatory affairs or engineering and 3+ years of experience in life sciences, biopharmaceutical, medical device, biologics regulatory or closely related field, OR. Doctorate Degree in science, law, health policy, regulatory affairs or engineering. Industry experience in oncology, NGS, IVD, CDx, CAP/CLIA, and/or regulatory
Dialysis Experience/CCHT Required. DaVita Kidney Care, is bringing our industry-leading clinical quality to patients on-site at skilled nursing facilities (SNF) through a new team called DaVita Skilled Nursing Dialysis Services.. Valid Certified Clinical Hemodialysis Technician (CCHT) certification. Support for you and your family: family resources, EAP counseling sessions, access Headspace®, backup child and elder care, maternity/paternity leave and more. Reimbursement for your Certified Hemodialysis Technician (CHT) license
We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges.. Author and maintain documentation as required to sustain regulatory compliance.. College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.. Minimum of 10 years experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA).. Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.
Review and provide feedback on CDM and study documents, including the Data Management Plan, study protocols, data transfer agreements, and data validation specifications.. Oversee the electronic data capture (EDC) database build process, including review of specifications, data validation documents, and user acceptance testing (UAT) during initial build and subsequent modifications.. Collaborate with Programming, Biostatistics, Clinical Operations, Patient Safety, Pharmacovigilance, Medical Science, and other teams to meet project timelines.. At least 8 years of clinical data management experience in biotech or pharma, with a strong understanding of late-phase drug development, preferably in Phase 3 Oncology trials.. Knowledge of clinical research regulations, including FDA, ICH, GCP, and GCDMP.
Review and provide feedback to CDM and study documents, including but not limited to the Data Management Plan, study protocols, data transfer agreements and data validation specifications. Oversee electronic data capture (EDC) database build process, including but not limited to review of specification and data validations documents and user acceptance testing (UAT) of the EDC during initial build and subsequent database modification. Collaborate with Programming, Biostatistics, Clinical Operations, Patient Safety and Pharmacovigilance, Medical Science, and other cross-functional teams to meet project deliverables and timelines. 8+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required. trong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
Experienced Recruitment Consultant - Life Sciences. A fantastic opportunity has arisen for an Experienced Recruitment Consultant at Senior/ Principal level & above, to join our Boston Office under Our Life Sciences Recruitment brand.. The recruitment industry is roaring right now and working as an Experienced Recruitment Consultant within our business will offer a very lucrative and exciting career path.. Catalyst Life Sciences - operating in the Biotech, Medical Devices, Pharmaceuticals and Consulting sectors placing into quality, regulatory affairs, engineering, technical operations, clinical development, data, medical affairs and information, and pharmacovigilance.. Paid company vacations with destinations such as Miami, Las Vegas & Ski trips in Europe!
Our cGMP storage solutions are custom-built for the pharmaceutical and biotech industries, managing mission-critical consumables, equipment, raw materials, and finished goods with precision.. Nationally acclaimed for laboratory relocation, principal investigator support, and other logistics services, Tobin Scientific's holistic approach and commitment to excellence make us an integral player in life science services.. We are seeking a Manager of Quality Systems to drive our quality assurance initiatives and maintain compliance with industry standards.. Periodic review and updates (as a quality reviewer), metadata review, document review, etc.. 3-5 years in a GMP quality function.