- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... selected individual will function with a high degree of independence and provide regulatory oversight for assigned products, in order to optimize label and obtain… more
- Merck & Co. (Durham, NC)
- …team goalsUnderstand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testingCapability to function effectively within ... and uses this knowledge in own workUnderstands and applies regulatory /compliance requirements relative to their roleInfluence, motivate, and energize individuals… more
- Merck & Co. (Durham, NC)
- …these programs.Author, review, and/or edit validation documents to support regulatory filingsSupport Change Control documentation for complex process, validation, ... analytical, equipment, facility/utility and/or automation changes.Lead validation topics in regulatory inspections by presenting and defending validation documentation.Develop technical… more
- Merck & Co. (Durham, NC)
- …and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.Build ... team goalsUnderstand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testingCapability to function effectively within… 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 ... to individual contributors. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory… more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC, commercial, and other areas) as ... To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor .NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… 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 ... related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research… more
- Merck & Co. (North Wales, PA)
- …and to support audits of pathology service providersApply understanding of regulatory requirements to support questions related to filings and regulatory ... for trials using pathology for evaluation of efficacy and safety. Regulatory experience supporting drug filingsPreferred Experience and Skills:Histotechnologist certification… more
- Merck & Co. (Durham, NC)
- …neededCollaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirementsProvides active support during audits and inspections ( ... discuss in more detail, please contact your HRBP or Talent Acquisition Advisor . VETJOBS #EBRGEmployees working in roles that the Company determines require routine… more
- Merck & Co. (North Wales, PA)
- …the area and/or companyMaintain knowledge of new technologies, industry standards, regulatory requirements, and our Company guidelines and SOPs.Able to work ... management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.Strong knowledge of the Drug… more
- Merck & Co. (Washington, DC)
- …will monitor, analyze, and communicate internally about federal legislative and regulatory activities and initiatives.- The Associate Director will also represent ... are not limited to: Research and provide analysis of federal legislation, regulatory proposals, government data, third party stakeholder activities, and other key… more
- Merck & Co. (Rahway, NJ)
- …auditing and Quality Risk Management.As required, participate in Regulatory Agency inspection activities.Deliver stewardship for company's corporate initiatives ... with end-to-end data governance.Expertise with configuration management.Knowledge of published regulatory agency data integrity, computer software assurance guidance.Moderate level… more
- Merck & Co. (Rahway, NJ)
- …and in the preparation of study documents for submission to regulatory agenciesExcellent verbal communication and presentation skills required; required to represent ... the group in internal meetings, in meetings with regulatory agencies and in scientific meetingsWorking knowledge of standard computer software applications for… 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 ... projects in Late Development Statistics.Lead the interaction with Clinical, Regulatory , Statistical Programming, Data Management, and other Company Research… more
- Merck & Co. (South San Francisco, CA)
- …DescriptionResponsibilities:Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to ... reports. Interact with colleagues from multiple areas, including discovery, regulatory affairs, project teams, and development functions.Partner with scientists and… more
- Merck & Co. (North Wales, PA)
- …with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory , Early/Late Development Statistics, Statistical Programming, , and other company ... all deliverables meet analysis requirements, standard operating procedures, and regulatory requirementsDesign, develop and apply safety evaluation methods (including… 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 ... and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and our Company's Research… 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 ... pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring … more
- Merck & Co. (Rahway, NJ)
- …imaging tools, and data analysis. You would also contribute towards regulatory submissions to enable clinical trials.Your main responsibilities include: Driving ... technology teams shaping analytical methods and tools of the future.Authoring regulatory submission documents and responding to agency questions across the project… more
