- Merck & Co. (Rahway, NJ)
- …& Controls ( CMC) , Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our ... company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions for products that may include… more
- Lundbeck (North Hyde, SD)
- …or Regulatory Affairs (Master's preferred). 3-5 years' experience in Regulatory Affairs within the pharmaceutical, biotech, or healthcare industry. Strong ... Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory... Regulatory Affairs Manager to lead and manage regulatory activities across our product portfolio. This role is… more
- AMEGO INC (Franklin, MA)
- …others as requested by the Vice President of Children's Services, Director of Healthcare Services, or other regulatory requirements. Provide supervision to staff ... School Program. The School RN assists the Director of Healthcare Services and Executive Vice President of Children's Services...documentation pursuant to the DESE, DEEC, DPH, and DCF regulatory requirements. The School RN is responsible for the… more
- Eisai, Inc (Nutley, NJ)
- …process for promotional programs, preferred. Experience working with PhRMA and Regulatory /Legal guidelines for healthcare provider interactions to ensure ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Merck & Co. (Rahway, NJ)
- …with opportunities to gain critical business acumen such as product knowledge, healthcare systems, payors and customers, regulatory , business operations and ... comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement… more
- Merck & Co. (North Wales, PA)
- …is responsible for ensuring data integrity, accessibility, and compliance with regulatory standards, while also enabling business users to derive actionable insights ... data governance approval process, ensuring compliance with internal policies and regulatory standards.Triage and respond to real-time inquiries related to data… more
- Merck & Co. (Rahway, NJ)
- …device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical ... and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...both internal teams and external stakeholders, including patients and healthcare professionals, with inquiries, case handling issues, and process… more
- Merck & Co. (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Reklame Health, Inc (New York, NY)
- …improvement, and driving operational efficiency in clinical environments. Knowledge of healthcare compliance and regulatory standards (eg, HIPAA) Leadership and ... forge a world where health equity and effortless access to exceptional mental healthcare can co-exist. About the Role Head of Clinical Operations This leadership… more
- Merck & Co. (Rahway, NJ)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- CHRISTUS Health (San Marcos, TX)
- …to Clinical Staff in all aspects of clinical operations including regulatory compliance. Provides professional nursing care for clinic patients in conjunction ... settingMinimum of 1 year of experience overseeing work of assigned unitsPrevious healthcare management experience, preferredRN license in good standing in state of… more
- Home Care Evolution (Merrillville, IN)
- …Ability to make informed decisions independently. Familiarity with EMR systems and healthcare regulatory requirements. Compensation: $45.00 - $55.00 per hour ... (license/certification if applicable). Minimum of [2-5] years of experience in healthcare administration or management (home health, hospice, or long-term care… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our company ... integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare . Our company is on a quest for cures and is committed to being… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programsFoster… more
- RELI GROUP INC (Baltimore, MD)
- …delivery models Understanding of BAM analytics and data governance within healthcare or regulatory environments Prior experience managing fixed-price federal ... contract EEO Employer: RELI Groupis an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status,… more
- Merck & Co. (Upper Gwynedd, PA)
- …integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare . Our Company is on a quest for cures and is committed to being ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... dataProduce tables and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling resultSupport… more
- BioAgilytix (Durham, NC)
- …ISO 27001).Oversee governance, risk, and compliance activities, including policy development, regulatory alignment (GxP/CLIA, GDPR, Part 11), and global data privacy ... vendor and third-party security risk, ensuring adherence to contractual and regulatory obligations.Define guardrails for AI and new technologies, including M365… more
