- CoxHealth (Lake Spring, MO)
- …future issues. The specialist serves as a liaison between patients, families, healthcare providers, and regulatory agencies to uphold patient rights, improve ... or patient advocacy * Skills ◦ Advanced knowledge of patient rights, regulatory requirements, and healthcare ethics. ◦ Strong leadership, team management,… more
- 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
- 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
- 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. (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
- 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. (Philadelphia, PA)
- Job DescriptionDescription The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety ... execution, and management of delivery of high quality and timely regulatory submissions.The responsibilities of the incumbent may include the following:Maintain… 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
- 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
- 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
- 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. (Durham, NC)
- …materials or managing a portfolio of complex process changes with regulatory impact Responsibilities Business Case Development Understanding the requirements of a ... Management - Supply Transitioning Defining key business requirements (validation, regulatory filing, inventory builds, and creating inventory transition plans to… 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. (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
- 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
- Merck & Co. (Rahway, NJ)
- …oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience supporting/writing regulatory filings… more
- Merck & Co. (Rahway, NJ)
- …Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements. - Defines and contributes to the development of training ... Familiarity with FDA Good Clinical Practices, ICH Guidelines, and other major regulatory agencies' regulations and guidance. - Experience working in a hybrid… more
- Formation Bio (New York, NY)
- …data workflows (NLP, embeddings, semantic search, knowledge graphs). Understanding of regulatory and compliance considerations in healthcare , pharma, or finance. ... data pillars interoperable, consistent, and actionable. You'll work across healthcare (EHR, claims, real-world data), commercial/pharma (pricing, formulary, market… 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
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