- Merck & Co. (North Wales, PA)
- …is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical ... investigator's brochures, clinical sections of submissions) per company and regulatory requirements.Applies an in-depth knowledge of medical writing responsibilities,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking applications for a Senior Scientist position available at the Rahway, NJ research facility. Join Small Molecule Analytical Research and ... and dedicated colleagues while developing and expanding your career.In your role as Senior Scientist, you will be part of a team developing innovative analytical… more
- Merck & Co. (North Wales, PA)
- …to other clinical scientists.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... in life sciences, preferred.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May ... talented and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for the… 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. (North Wales, PA)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for… more
- Merck & Co. (Rahway, NJ)
- …department of our Research & Development Division is seeking applicants for a Senior Scientist position available at our research facility. The Senior Scientist ... program deadlines.Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external scientific publications.Strong… 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. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... diverse background and expertise, including research scientists, clinical scientists, regulatory experts, IT specialists, etc.Identify opportunities to add value to… more
- Merck & Co. (North Wales, PA)
- …(CTT)May work closely with the Medical Writer on clinical/scientific and regulatory documents and the Study Manager on study deliverables.May provide ... sciences, preferred. Required experience & skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH) - Ability to manage multiple… 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)
- …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. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... assignments Review & approve documents in accordance with local, corporate & regulatory regulations Collaborate, review & approve IQ, OQ & PQ protocols for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... all applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters in MA. Internal relationships include… 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 ... that they need.Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects. Sharing lessons learned… more
- Merck & Co. (Rahway, NJ)
- …& Development Division , Human Health, and our Manufacturing Division - Senior Leaders.Executes business development and commercial activities in the evaluation and ... o ur Research & Development Division Process, Analytical and CMC Regulatory groups.Defines, assesses, and presents business analyses for potential transactions… more
- Merck & Co. (Rahway, NJ)
- …provide insights into implementation of strategic direction.In support of the Senior Director, Operations and Reference Data Management, ensures project delivery ... organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for clinical data standards, technology, and clinical data… more
