Collecting information
Organizing data
Every day, more than 40,000 Hartford HealthCare employees come to work with one thing in common: Pride in what we do, knowing every moment matters here.. The Institute of Living, one of the first mental health centers in the U.S., remains one of America’s leading not-for-profit centers for patient care, research and education in the fields of behavioral, psychiatric and addiction disorder.. Programs are offered for children, adolescents and adults struggling with mental illness as well as offering services specializing in Anxiety, Eating Disorders, and Geriatric Services.. With locations around the state, Hartford HealthCare offers exciting opportunities for career development and growth.. Here, you are part of an organization on the cutting edge – helping to bring new technologies, breakthrough treatments and community education to countless men, women and children.
The Director of Nursing (DON) plans, organizes, develops, and directs the overall operation of the Nursing department to ensure the highest degree of quality patient care in accordance with all applicable laws and regulations.. We offer short-term to long-term care and a variety of living options and professional clinical services.. Manage and allocate nursing resources, including staffing, budgeting, and equipment procurement.. Implement and oversee quality improvement initiatives to enhance patient safety and satisfaction.. Stay updated on advances in nursing practice and technology to facilitate evidence-based care.
- Board Certified or Board EligibleInternal Medicine, Family Medicine or Geriatric Medicine. Employed by a PRIVATE group (not the nursing home). Physician would need to be able to obtain liability insurance (negotiable for partial or full reimbursement after 1 year of working). Physician will need to have active Medicare and Medicaid numbers. Suffolk County, Long Island, NY
The Pediatric Nurse Practitioner (NP) will be the Primary Care Manager (PCM) for a panel of up to 1,300 patients. Provide a full range of primary care pediatric nurse practitioner services in accordance with privileges granted by the military treatment facility (MTF). Perform therapeutic procedures and prescribe pediatric treatment and medications based on assessment results and standards of care within the scope of practice of a pediatric nurse practitioner as defined and approved on the provider privileges list. Certified as a Pediatric Nurse Practitioner by the Pediatric Nursing Certification Board (PNCB), American Nurses Credentialing Center (ANCC), or the recognized national nursing certification organization in Pediatrics as appropriate. Familiarity with Department of Defense (DoD), Federal, State, non-profit healthcare systems and organizations, to include DoD Tri-Service Military Healthcare Systems, TRICARE purchased care system, Medicare, Medicaid, and the Veterans Administration (VA) Preferred
We are seeking a detail-oriented Clinic Billing Specialist to join our team. Ensure compliance with billing and coding regulations.. Previous experience in medical billing and coding.. Proficiency with billing software and electronic health records systems.. If you are a self-motivated individual with a passion for healthcare administration, we encourage you to apply for this position.
Under supervision of the Director, the Quality Improvement Specialist (QIS) supports the Centers for Medicare & Medicaid Services (CMS) Quality Innovation Network–Quality Improvement Organization (QIN-QIO) Program by providing hands-on technical assistance and quality improvement (QI) support to healthcare providers—primarily nursing homes, hospitals, and physician practices.. This position plays a vital role in driving the adoption of evidence-based interventions, guiding providers through regulatory requirements, and helping them improve safety, care quality, and outcomes for Medicare beneficiaries through onsite visits, virtual coaching, and educational outreach.. Apply evidence-based QI methodologies to conduct comprehensive assessments, perform root cause analyses, and deliver technical assistance aligned with CMS project goals and metrics.. Promptly and accurately document project activities, site visits, provider communications, and outcomes using HSAG and CMS-approved systems.. Stay current on best-practice guidelines and regulatory updates from CMS, the Centers for Disease Control and Prevention (CDC), Substance Abuse and Mental Health Services Administration (SAMHSA), and other regulatory agencies.
Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. The Senior Director, Regulatory Affairs is a strategic and operational leader responsible for overseeing regulatory strategy, execution, and compliance across all phases of drug development but with a primary focus on early-stage first-in-human / first-in-class molecules. The Senior Director will lead a team of Regulatory Affairs professionals and serve as the primary liaison with global health authorities, including the FDA, EMA, and Health Canada. Deep knowledge of Health Canada and FDA regulatory frameworks, including CTA and IND processes. Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules. Lead and Manage Global Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (e.g., BLA, MAA). Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance documents. Master Degree (MS/MA) Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required.. Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the team's activities from IND-enabling studies and first-in-human (FIH) studies through clinical proof of concept (PoC) trials, and to facilitate post-PoC transitioning to our Otsuka affiliate for global clinical development & commercialization.. Effectively negotiate alignment with Otsuka parent and affiliate organizations on strategy & messaging to produce optimal outcomes from global health authority interactions.. Define and oversee phase-appropriate CMC regulatory strategy for biologics, including CMC regulatory-specific risk mitigation, and ensuring seamless progression from discovery through early clinical development.. Support CMC functions (e.g. Process Development, Analytical Development, Manufacturing and Quality Control) pertaining to the preparation and content of CTA/IMPDs, PPQs, INDs dossiers to ensure timely delivery of final documents to be included in submissions.. 15+ years of global regulatory affairs experience, including at least 5 - 7 years in biologics, with expertise in early-stage development (IND-enabling, FIH, PoC), CMC regulatory strategy, and global compliance.
Functional areas of oversight include: St. Francis Hospital Operating Room, Pre-op and PACU. Ensures the quality of Perioperative patient care in the Operating Room and serves as a role model for professional nursing practice. At UCSF St. Francis Hospital, our Operating Room and Surgical Services department embodies excellence in surgical care, providing patients with state-of-the-art facilities and a dedicated team of highly skilled professionals. At UCSF St. Francis Hospital, patient safety and comfort are our top priorities. UCSF St. Francis Hospital is dedicated to serving our community. Strong hospital management experience, with progressive and in-depth expertise in patient care services.
Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS).. Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.. The Senior Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs.. This role is based in Waltham, MA without the possibility of being fully remote.. Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc).
Bicara Therapeutics is seeking a proactive and detail-oriented Regulatory Affairs Program Manager to contribute to the development of regulatory strategies and to coordinate regulatory activities across the product lifecycle.. Minimum 2-4 years of experience in regulatory affairs within the biotech or pharmaceutical industry strongly preferred. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-ß).. Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-ß signaling within the tumor microenvironment.. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types.
Job Summary: We are seeking a Regulatory Affairs Specialist (Contractor) with expertise in China NMPA registration for ultrasound imaging devices.. The role involves supporting the preparation and compilation of regulatory submissions to ensure timely product approvals in China.
The Director, Regulatory Affairs is a senior leadership role responsible for overseeing all aspects of regulatory compliance, advocacy, and strategic engagement with regulatory bodies.. Ensure that nuclear facilities and operations are in full compliance with regulatory standards such as the Atomic Energy Act, the Code of Federal Regulations (CFR), and industry-specific safety and environmental standards.. Work closely with senior leadership to integrate regulatory considerations into long-term business strategy, including nuclear plant construction, upgrades, or decommissioning.. Bachelor's degree (minimum), Master's or advanced degree preferred (e.g., Nuclear Engineering, Regulatory Affairs, Environmental Science, Law).. 15+ years in nuclear power industry, with 10+ years in regulatory affairs, including leadership experience in managing teams and projects, and specific regulatory experience with NRC or equivalent bodies.
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials.. Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.. Minimum of 8-years’ regulatory experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience
About Us: Big Horn Rehabilitation and Care Center is a leading provider of skilled nursing and rehabilitation services in the beautiful community of Sheridan, Wyoming.. Our 128-bed facility specializes in short-term rehabilitation, long-term care, respite care, and comfort care services.. We proudly serve the people of Wyoming through accepting Medicare, Medicaid, and private insurance.. Position Overview: A Registered Nurse is a healthcare professional primarily responsible for providing direct care, which includes assessing patient health, administering medications, monitoring vital signs, and collaborating with doctors to ensure optimal patient outcomes.. Every day, you’ll have the opportunity to create positive change and provide comfort, care, and connection.
McLaren Northern Michigan is a 202-bed regional hospital located in Petoskey, Michigan serving residents in 22 counties across northern Lower Michigan and the eastern part of the Upper Peninsula. McLaren Northern Michigan has a network of primary care providers and specialty care clinics throughout the region, and an outpatient surgery center in Cheboygan. It has achieved Magnet status for nursing excellence, been named a Top 50 heart hospital in the U.S. by IBM Watson Health and received the highest national ratings from the Centers for Medicare and Medicaid Services for quality and safety. McLaren Northern Michigan is a subsidiary of McLaren Health Care , a fully integrated health network committed to quality, evidence-based patient care and cost efficiency. In the winter, the Winter Sports Park offers outdoor hockey, ice skating, and sledding; while the summer provides tubing, swimming, and countless beaches, and woods to explore.
Ensure that nuclear facilities and operations are in full compliance with regulatory standards such as the Atomic Energy Act, the Code of Federal Regulations (CFR), and various industry-specific safety and environmental standards.. Work closely with senior leadership to integrate regulatory considerations into long-term business strategy, including nuclear plant construction, upgrades, or decommissioning.. Identify, assess, and mitigate regulatory risks related to the licensing, operation, and shutdown of nuclear plants.. Bachelor's degree (minimum), Master's or advanced degree preferred (e.g., Nuclear Engineering, Regulatory Affairs, Environmental Science, Law).. 15+ years in nuclear power industry, with 10+ years in regulatory affairs, including leadership experience in managing teams and projects, and specific regulatory experience with NRC or equivalent bodies.
Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.. Develops the global regulatory plan for inclusion in the design file, advising the Company on product classifications and registration path in key markets based on the commercial plan.. Minimum of 8-years’ regulatory experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience. Experience in the preparation of regulatory submissions to US FDA, Health Canada and/or EU Notified Body with in the past 8 years.. Ability to prioritize and balance work load, with minimal supervision and in a fast pace environment
But working at Bristol Myers Squibb is anything but usual.. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.. The Executive Director of Biostatistics will provide scientific and operational leadership across oncology programs, guiding data and statistical strategy, talent development, and cross-functional collaboration to support the successful development of innovative therapies.. 12+ years of experience in biostatistics in the pharmaceutical industry with clinical trials, drug development, pharmaceutical industry or healthcare experience (Oncology experience preferred). Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.