Collecting information
Organizing data
Maxim Healthcare Services is seeking an RN or LPN to assume responsibility and accountability for the application of the nursing process and the delivery of patient care. Other RN or LPN duties as assigned. Current PPD or Chest X-Ray. Competitive pay & weekly paychecks.. We offer private duty nursing, skilled nursing, physical rehabilitation, companion care, respite care and behavioral care for individuals with chronic and acute illnesses and disabilities.
Odysseys Unlimited, a Newton (Massachusetts) based tour operator and direct marketer, provides international small group tours to older Americans including members of some of the country's most prestigious non-profit organizations. Title: Quality Assurance & Communications Specialist.. This position requires a candidate who possesses exceptional written communication, judgment, proofreading, and customer service skills, as well as a keen attention to detail and ability to effectively prioritize tasks. Proofread guest correspondence for proper grammar, spelling, and style according to company guidelines; review to ensure content is accurate and complete.. Must demonstrate strong writing skills with excellent spelling, grammar, and proofreading abilities, as well as exceptional attention to detail and accuracy; maintains quality and accuracy across all assignments
Southcoast Health is a not-for-profit, charitable, health system with multiple hospitals, clinics and facilities throughout Southeastern Massachusetts and Rhode Island.. Shift: Evening shift with weekend and holiday rotation; 11:00am - 11:30pm. Professional growth opportunities and customized leadership training. Under direction of individually assigned Manager, Patient Care and/or Director, Patient Services, perform diversified duties both within and in support of the department including leadership, performance review process, daily operations, departmental manpower scheduling , fiscal responsibilities, educational responsibilities, performance improvement , liaison, quality, etc.. Current RN Registration in the Commonwealth of Massachusetts is required.
Reporting to the Head of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities that support the company's product development strategies and providing guidance to broader CMC functions. Lead the development of CMC regulatory strategy for assigned programs, identifying key issues, necessary remediation activities, and opportunities for acceleration throughout project/product life cycle. Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and global CMC regulatory submissions (e.g., original INDs, CMC amendments, IMPD Amendment, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development. Coordinate and conduct global CMC regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations to Regulatory department, Product Development Team Lead, or executive management, as required. A minimum of 10 years of increasing responsibility in CMC Regulatory Affairs within the biopharmaceutical industry is required.
May represent Alexion as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca's internal knowledge and expertise.. Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.. Alexion provides reasonable accommodations to meet the needs of candidates and employees.. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com.
Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology. Computer proficiency in Microsoft Office (including Word, Excel, PowerPoint, and Project Management tools) with some experience with Veeva Vault products and MW artificial intelligence (AI) software/writing tools would be a g plus. Head (Executive Director) Rare Disease, US Medical Affairs.. Medical Director, Drug Safety & Pharmacovigilance.. Senior Medical Director, Drug Safety & Pharmacovigilance
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.. The Director of Regulatory Affairs, Advertising and Promotions will also collaborate with internal stakeholders in commercial, medical affairs and legal to ensure external communications, including but not limited to promotional communications, are compliant and align with Lantheus’ strategic commercial, medical, and regulatory objectives.. Serve as a strategic partner to internal stakeholders including Commercial, Medical Affairs, Corporate Communications, Legal and Compliance providing regulatory guidance and perspectives on key business strategies, objectives, and tactics.. Advanced degrees (PharmD, PhD, MS, MBA, JD) preferred.. Minimum of 10+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a minimum of 5 years’ experience specific to Regulatory Affairs – Advertising and Promotion.
We're looking for someone who is not only adept at managing complex product and program lifecycles but also thrives in highly regulated environments, with a deep understanding of FDA requirements, QMS systems, and the unique challenges of digital health.. Master's or equivalent work experience in Healthcare, Regulatory Affairs, Biomedical Engineering, or related fields (preferred).. Deep knowledge of FDA regulations, including 510(k) clearance processes, SaMD guidelines, and relevant international regulatory frameworks (e.g., CE marking, MDR).. Experience with clinical trials and/or real-world evidence collection and how to integrate clinical data into product development.. Solid understanding of software product lifecycle management, particularly for regulated digital health products (from early design through development, testing, regulatory approval, and post-market monitoring).
About the job Mailroom Quality Assurance Associate Mailroom Quality Assurance Associate needs 1+ years experience required.. Experience of working with teams in a collaborative environment•Must possess excellent communications skills (i.e., interpersonal, written, verbal and presentation)Mailroom Quality Assurance Associate duties: Maintains Quality Management System (QMS) programs and initiatives.. Provides critical information for audits and reviews/analyzes data and documentation.. Maintains all required documentation to meet the required security compliance standards and to meet audit control standards, Standard Operating Procedures (SOP), Forms, spreadsheets, data analytics.. Identifies the interface of key activities within and between the functions of the organization.
The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. Actively collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca's internal knowledge and expertise. Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients worldwide. 7+ years of medical writing experience in pharma, biopharma, or CRO. Track record of contributing to successful regulatory filings (IND/CTAs, NDA/BLA/MAA). Knowledge of biologics, clinical research, study design, biostatistics, and medical terminology. Proficiency in Microsoft Office, with experience in Veeva Vault and AI writing tools a plus.
Waters, the world's leading specialty measurement company that cares about inclusion and diversity is seeking for a Design Quality Engineer, Clinical, to be located in Milford, Massachusetts, USA. This position will have a hybrid work schedule ( three days per week on-site).. Also supports post market activities (e.g. product release, design changes, non-conformances, CAPA, complaints, post-market surveillance), regulatory documentation creation and maintenance, supplier management, auditing and general Quality Management System (QMS) activities.. Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years.. Diversity and inclusion are fundamental to our core values at Waters Corporation.. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law.
The Quality Assurance Manager drives quality improvements for our customers across the Americas, fostering a culture of continuous improvement and operational excellence.. Promote the development of a company-wide culture of quality assurance and understanding of key QMS elements.. Experience with Immunohistochemistry methods and evaluation. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.. Please contact us at applyassistance@danaher.com to request accommodation.
The Regulatory Affairs Director (RAD), Global Regulatory Strategy, will be responsible for the development and implementation of global regulatory strategies for all assigned products and therapeutic areas.. Contribute to internal governance and advisory bodies for strategic and operational insights.. Collaborate with senior management and enterprise functions to provide regulatory insights and drug development expertise.. Strong knowledge of drug development, regulatory policy, and scientific and business judgment.. Bachelor’s Degree in life sciences or related field; postgraduate degrees (MSc, PhD) are a plus.
Nursing care is provided in accordance with the stated philosophy and standards established by the Nursing Services Department and regulatory agencies.. The Patient Care Technician is accountable for the aspects of nursing care they are directed to provide within their scope of practice.. Certified Nursing Assistant training program strongly preferred.. Minimum of one year acute care experience or medical/surgical clinical experience preferred.. Certified Nursing Assistant certification strongly preferred.
Are you a skilled Quality Assurance Analyst with a proven track record testing Web based applications, data intake and warehousing systems?. Thoroughly document test case results utilizing tools such as MS Excel, Teams, Azure DevOps, CHIA collaboration tools and others Document issues in CHIA bug tracking applications, detailing functionality requirements deficits.. Review and provide feedback to Business Analysts on application and systems requirements documents Attend and / or lead bug triage meetings with development and business teams Triage, logging and tracking of production bugs for LTC, RPO, and other CHIA Web Applications as applicable Comply with CHIA data security requirements and assist in identifying potential data security risks.. Able to adapt to shifting priorities based on business needs and multi-task Health Information and Analysis Industry knowledge Experience with MS O365, SQL, Snowflake, MS Azure, Excel, ETL Tools Bachelor’s degree or equivalent work experience required.. Applications Development Job Family Level I; Quality Assurance Analyst I Full salary range is: $71,453.20- $102,351 Comprehensive Benefits When you embark on a career with the Commonwealth, you are offered an outstanding suite of employee benefits that add to the overall value of your compensation package.
The PACU RN is responsible for monitoring and assessing patients' vital signs, ensuring they recover safely from anesthesia, managing pain, and monitoring for any complications to ensure optimal recovery outcomes.. Provide education to patients and families about post-operative care, wound care, and pain management. Monitor and support the use of medical devices, such as oxygen therapy, IV lines, and pain management equipment.. Qualifications:Education: Bachelor of Science in Nursing (BSN) preferred; Associate Degree in Nursing (ADN) accepted.. Experience: Minimum of 1-2 years of acute care or perioperative nursing experience preferred, with a focus on post-anesthesia care.
We understand that every business is unique, so we tailor our services-including payroll processing, tax compliance, and HR support-to meet the specific needs of our clients.. The software quality assurance analyst will analyze, test and implement software quality assurance systems and procedures to support software application releases.. Work with developers on web-reporting platform and provide ongoing assistance and education on QA testing methodologies, systems, processes and standards. Use regression testing to ensure full functionality of Gallup's reporting site. 5+ years of software QA experience related to functional or front-end QA testing required
on W2 100% Remote Must Have Python Java Automation testing Qualifications. 2-4 years of experience in software testing and test automation. Strong understanding of software testing methodologies and best practices. Familiarity with AWS cloud-based testing platform.. Identify opportunities to expand test automation coverage and improve testing efficiency
Familiarity with IT and/or Computer System Validation (CSV) concepts. Industries Translation and Localization. Entry Level 2025 | Audit Staff | Braintree (44580) Greater Boston $70,000.00-$80,000.00 2 weeks ago. Jr. Accountant - Part Time Live Nation Boston Boston, MA $80,000.00-$85,000.00 3 weeks ago. Entry Level 2025 | Audit Staff | Braintree (44580) Peabody, MA $70,000.00-$75,000.00 1 week ago