Collecting information
Organizing data
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.
Find Your Passion and Purpose as a Home Health Patient Care Manager. Company store credit for your first AccentCare-branded scrubs for patient-facing employees. Previous experience in home care setting with two years management or supervisory experience, preferred.. Knowledge of accepted professional standards and practice, Medicare Conditions of Participation, and federal, state, and local regulatory requirements. AccentCare is proud of how we are building a culture and inclusive infrastructure to help elevate the voice of all our employees with a special focus on the underrepresented and marginalized.
The Regional Clinical Reimbursement Specialist is directly responsible for the management of the MDS RAI process, Medicaid Case Mix, Medicare/PDPM and Managed Care systems across 5 centers to ensure appropriate reimbursement in accordance with all applicable laws and regulations.. ICD-10 Coding for accuracy and reimbursement. Serves as a resource to facility teams in Medicare, Medicaid, ACO and Managed Care/Commercial plans to capture clinical complexity that supports favorable clinical and financial outcomes. Works collaboratively with Regional Clinical, Operations and Quality Assurance team to provide regional and facility interdisciplinary teams with education and support for the development of systems to address and manage Quality Measures, CMS Five Star Rating, VBP and QRP data.. Supports centers through DPH survey, plans of correction, and Case Mix Audits.
Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue.. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).. Role Summary: The Senior Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs.. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
MMS is a award-winning, data-focused clinical research organization (CRO).. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.. Join us at MMS and be part of a team that is shaping the future of clinical research.. Discover more about our exciting opportunities and why MMS is a great place to advance your career.. College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
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.
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
The Senior Specialist, Pharmacovigilance (PV) Quality and Compliance encompasses a key leadership role in providing direction to the PV department and promote the spirit of proactive, continuous quality improvement in adverse event case management for all Deciphera Pharmaceuticals Clinical Trials, Extended Access Programs and post marketing (where applicable). This position will report to the Senior Manager, Pharmacovigilance (PV) Quality and Compliance and be remote or near the Waltham, MA office. Assist in managing vendor and business partner oversight by supporting audit follow-ups, tracking CAPA implementation, and ensuring appropriate documentation. Minimum of 3+ years of experience in Pharmacovigilance (PV) operations and/or quality roles within the pharmaceutical, biotech, or healthcare industry. Hands-on experience with safety databases (e.g., Argus) for case management and regulatory reporting.
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.
The Senior Specialist, Pharmacovigilance (PV) Quality and Compliance encompasses a key role in providing direction to the PV department and promote the spirit of proactive, continuous quality improvement in adverse event case management for all Deciphera Pharmaceuticals Clinical Trials, Extended Access Programs and post marketing (where applicable).. This position will report to the Senior Manager, Pharmacovigilance (PV) Quality and Compliance and be remote or near the Waltham, MA office.. Assist in managing vendor and business partner oversight by supporting audit follow-ups, tracking CAPA implementation, and ensuring appropriate documentation.. Minimum of 3+ years of experience in Pharmacovigilance (PV) operations and/or quality roles within the pharmaceutical, biotech, or healthcare industry.. Hands-on experience with safety databases (e.g., Argus) for case management and regulatory reporting.
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.
This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development.. The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.. Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.. PhD or equivalent degree in statistics/biostatistics with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience. Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
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.
Establish and monitor systems for collection of claims data, processing claims, and reporting functions related to fee-for-service billing.. Functions as liaison to the provider relations department of the payors.. Serves as liaison to Practice Management application vendors around claims processing and financial reporting.. Collaborates with AVP of Finance around issues related to revenue reports and claims processing for annual audit.. Proficiency in medical billing codes (CPT, ICD-10, HCPCS)
The Associate Director will be the technical lead for Drug Product small molecule drug product development, manage outsourced development activities, and handle cGMP manufacturing campaigns.. This individual will collaborate with partners in Supply Chain, Quality Assurance, Regulatory Affairs, Finance and various CRO/CMO’s to achieve Rhythm’s objectives.. Collaborates with internal stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs.. Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA, NDA, MAA etc).. Early formulation development (animal studies) to support discovery and preclinical stages of drug development
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).. Additionally, you will need to bring best practices and creative problem-solving abilities to support high-speed medical development in a consumer wearable company.. At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience.. An employer who violates this law shall be subject to criminal penalties and civil liability.
Vicarious Surgical is hiring an Agile Product Owner to join our team in Waltham, MA. In this role, you will be responsible for defining the software and electrical technical product roadmap and vision for Vicarious Surgical’s robotic platform, working as the software liaison between the software development/electrical teams and the cross-functional stakeholders. Vicarious Surgical is a next-generation robotics company developing disruptive technology with the goal of increasing the efficiency of surgical procedures, improving patient outcomes, and reducing healthcare costs. Collaborate with various stakeholders, including Product Development, Marketing, Quality, and Regulatory Affairs team members and leadership. 5-7+ years of experience working as a Software or Systems Engineer, Product Owner, or Product Manager in complex device software development; experience with robotics systems, medical devices, and/or UI/UX software development is helpful. Desired Certified SAFe Product Owner/Product Manager or Release Train Engineer.
Job Title: Database Developer – MySQL (Healthcare EMR/EHR Systems). Perform ETL operations, data migration, and validation from legacy systems.. Familiarity with data privacy regulations and best practices for healthcare data (e.g., HIPAA compliance).. Exposure to EMR platforms such as Epic, Cerner, or Athenahealth.. Harvard Square, One Mifflin Place
We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs.. With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed.. This position also requires knowledge in biological sciences, strong organizational, management, interpersonal skills, and familiarity with a variety of the field's concepts, practices, and procedures.. Manages the day-to-day clinical operations, including management of vendors (e.g., CROs, bioanalytical labs) and coordination of activities.. Experience with CNS and Rare disease therapeutic areas is required.
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 Clinical Trial Associate (CTA) provides Clinical Operations support in the initiation, execution, and close-out of global clinical trials.. This role is based in Waltham, MA, without the possibility of being fully remote.. Collect and track documents for the trial master file (TMF), perform TMF reviews to ensure completeness, and support inspection readiness activities.. Experience working across multiple functional areas, e.g., Quality Assurance, Data Management, Biostatistics, Medical Writing, Clinical Supply, Finance.